Trial Outcomes & Findings for Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in Non-small Cell Lung Cancer (NSCLC) With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer (CRC) (NCT NCT02437136)
NCT ID: NCT02437136
Last Updated: 2025-03-20
Results Overview
The ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR). CR: Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 millimeters (mm). PR: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%. For purposes of analysis, 1 month was considered to be 30.4375 days.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
191 participants
Primary outcome timeframe
From date of randomization to date of progression (up to 765 days)
Results posted on
2025-03-20
Participant Flow
The study was conducted in 2 phases, a Dose Escalation/Confirmation Phase (Phase 1b) and an Expansion Phase (Phase 2).
Per protocol, 9 participants in the Confirmation Phase who rolled over to Cohort 2, and the other 7 participants who rolled over to Cohort 1 in the Expansion Phase, were counted in the Expansion Phase Population rather than in the Escalation/Confirmation Phase Population for the purpose of collecting data.
Participant milestones
| Measure |
Phase 1b (Dose Escalation): Entinostat 3 mg Weekly + Pembrolizumab
Participants with non-small cell lung cancer (NSCLC) received entinostat 3 milligrams (mg) administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via intravenous (IV) infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 1b (Dose Escalation): Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 1b (Dose Confirmation): Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a programmed cell death receptor-1 (PD-1)- or programmed cell death ligand-1 (PD-L1)-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with colorectal cancer (CRC) (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|---|---|---|---|---|---|---|---|
|
Dose Escalation/Confirmation (Phase 1b)
STARTED
|
6
|
7
|
9
|
0
|
0
|
0
|
0
|
|
Dose Escalation/Confirmation (Phase 1b)
Received at Least 1 Dose of Study Drug
|
6
|
7
|
9
|
0
|
0
|
0
|
0
|
|
Dose Escalation/Confirmation (Phase 1b)
COMPLETED
|
2
|
7
|
9
|
0
|
0
|
0
|
0
|
|
Dose Escalation/Confirmation (Phase 1b)
NOT COMPLETED
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Expansion (Phase 2)
STARTED
|
0
|
0
|
0
|
18
|
76
|
53
|
38
|
|
Expansion (Phase 2)
Received at Least 1 Dose of Study Drug
|
0
|
0
|
0
|
18
|
76
|
53
|
38
|
|
Expansion (Phase 2)
COMPLETED
|
0
|
0
|
0
|
5
|
11
|
17
|
10
|
|
Expansion (Phase 2)
NOT COMPLETED
|
0
|
0
|
0
|
13
|
65
|
36
|
28
|
Reasons for withdrawal
| Measure |
Phase 1b (Dose Escalation): Entinostat 3 mg Weekly + Pembrolizumab
Participants with non-small cell lung cancer (NSCLC) received entinostat 3 milligrams (mg) administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via intravenous (IV) infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 1b (Dose Escalation): Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 1b (Dose Confirmation): Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a programmed cell death receptor-1 (PD-1)- or programmed cell death ligand-1 (PD-L1)-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with colorectal cancer (CRC) (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|---|---|---|---|---|---|---|---|
|
Dose Escalation/Confirmation (Phase 1b)
Death
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Expansion (Phase 2)
Death
|
0
|
0
|
0
|
6
|
37
|
29
|
24
|
|
Expansion (Phase 2)
Withdrawal by Subject
|
0
|
0
|
0
|
7
|
25
|
4
|
2
|
|
Expansion (Phase 2)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
3
|
3
|
2
|
Baseline Characteristics
Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in Non-small Cell Lung Cancer (NSCLC) With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer (CRC)
Baseline characteristics by cohort
| Measure |
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
n=76 Participants
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
n=53 Participants
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 1b (Dose Escalation): Entinostat 3 mg Weekly + Pembrolizumab
n=6 Participants
Participants with NSCLC received entinostat 3 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
n=18 Participants
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
n=38 Participants
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
Age · 44 years and younger
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Age, Customized
Age · 45 to 64 years
|
35 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=21 Participants
|
90 Participants
n=8 Participants
|
|
Age, Customized
Age · 65 to 74 years
|
25 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=21 Participants
|
57 Participants
n=8 Participants
|
|
Age, Customized
Age · 75 years and older
|
15 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=21 Participants
|
80 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=21 Participants
|
111 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=21 Participants
|
164 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to date of progression (up to 765 days)Population: Full analysis set (FAS) included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data.
The ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR). CR: Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 millimeters (mm). PR: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%. For purposes of analysis, 1 month was considered to be 30.4375 days.
Outcome measures
| Measure |
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
n=18 Participants
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
n=76 Participants
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
n=53 Participants
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
n=37 Participants
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Objective Response Rate (ORR), as Assessed Using Immune Response RECIST (irRECIST)
|
22.2 percentage of participants
Interval 6.4 to 47.6
|
9.2 percentage of participants
Interval 3.8 to 18.1
|
18.9 percentage of participants
Interval 9.4 to 32.0
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Data were not censored for CBR analysis.
The CBR was defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) lasting for at least 6 months. CR: Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 mm. PR: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%. SD: Sum of the diameters (longest for nonnodal lesions, shortest for nodal lesions) of target and new measurable lesions neither CR, PR, (compared to baseline) or progressive disease (PD) (compared to nadir).
Outcome measures
| Measure |
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
n=18 Participants
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
n=76 Participants
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
n=53 Participants
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
n=37 Participants
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Clinical Benefit Rate (CBR), as Assessed Using irRECIST
|
33.3 percentage of participants
Interval 13.3 to 59.0
|
14.5 percentage of participants
Interval 7.5 to 24.4
|
35.8 percentage of participants
Interval 23.1 to 50.2
|
8.1 percentage of participants
Interval 1.7 to 21.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Data were not censored for CBR analysis.
The CBR was defined as the percentage of participants with a confirmed CR, PR, or SD lasting for at least 6 months. CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
n=18 Participants
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
n=76 Participants
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
n=53 Participants
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
n=37 Participants
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: CBR, as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
22.2 percentage of participants
Interval 6.4 to 47.6
|
14.5 percentage of participants
Interval 7.5 to 24.4
|
30.2 percentage of participants
Interval 18.3 to 44.3
|
2.7 percentage of participants
Interval 0.1 to 14.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Data were censored for PFS analysis based on prespecified analysis.
PFS was defined as the number of months from randomization to PD or death due to any cause, whichever occurred first. PD: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions increases ≥20% (compared to nadir), confirmed by a repeat, consecutive observation at least 4 weeks from the date first documented. Number of participants without evidence of progression or death at Month 6 are reported.
Outcome measures
| Measure |
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
n=18 Participants
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
n=76 Participants
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
n=53 Participants
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
n=37 Participants
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Progression Free Survival (PFS), as Assessed Using irRECIST
|
3 Participants
|
17 Participants
|
20 Participants
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Data were censored for PFS analysis based on prespecified analysis.
PFS was defined as the number of months from randomization to PD or death due to any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm; the appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. Number of participants without evidence of progression or death at Month 6 are reported.
Outcome measures
| Measure |
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
n=18 Participants
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
n=76 Participants
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
n=53 Participants
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
n=37 Participants
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: PFS, as Assessed Using RECIST 1.1
|
3 Participants
|
17 Participants
|
17 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of randomization to PD or death due to any cause (up to 765 days)Population: FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data.
PFS was defined as the number of months from randomization to PD or death due to any cause, whichever occurred first. PD: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions increases ≥20% (compared to nadir), confirmed by a repeat, consecutive observation at least 4 weeks from the date first documented. For purposes of analysis, 1 month was considered to be 30.4375 days.
Outcome measures
| Measure |
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
n=18 Participants
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
n=76 Participants
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
n=53 Participants
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
n=37 Participants
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: PFS Duration, as Determined by the Local Investigator Using irRECIST
|
2.76 months
Interval 1.18 to 4.07
|
2.83 months
Interval 1.51 to 4.14
|
4.40 months
Interval 2.79 to 6.97
|
1.91 months
Interval 1.38 to 2.79
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of randomization to PD or death due to any cause (up to 765 days)Population: FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data.
PFS was defined as the number of months from randomization to PD or death due to any cause, whichever occurred first. PD: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions increases ≥20% (compared to nadir), confirmed by a repeat, consecutive observation at least 4 weeks from the date first documented. For purposes of analysis, 1 month was considered to be 30.4375 days.
Outcome measures
| Measure |
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
n=18 Participants
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
n=76 Participants
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
n=53 Participants
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
n=37 Participants
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: PFS Duration, as Determined by the Local Investigator Using RECIST 1.1
|
2.76 months
Interval 1.18 to 4.07
|
2.69 months
Interval 1.48 to 4.07
|
2.96 months
Interval 1.45 to 6.24
|
1.91 months
Interval 1.38 to 2.79
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of randomization to the date of death (up to 765 days)Population: FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data.
Overall survival was defined as the number of months from randomization to the date of death (due to any cause). For purposes of analysis, 1 month was considered to be 30.4375 days.
Outcome measures
| Measure |
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
n=18 Participants
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
n=76 Participants
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
n=53 Participants
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
n=37 Participants
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Overall Survival
|
25.20 months
Interval 3.58 to
Due to smaller number of participants with an event, the upper limit of 95% confidence interval (CI) could not be calculated.
|
11.73 months
Interval 7.56 to 13.37
|
12.52 months
Interval 8.51 to 28.25
|
9.79 months
Interval 6.11 to 14.36
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start date of CR or PR to date of progression (up to 765 days)Population: FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Here, 'Overall number of participants analyzed' = participants who achieved objective response.
Duration of response was defined as number of months from start date of CR or PR (whichever occurred first) and subsequently confirmed, to the first date that recurrent or progressive disease was documented. CR: Disappearance of all target lesions and any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR: At least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, sum must also demonstrate an absolute increase of ≥5 mm; appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. For purposes of analysis, 1 month was considered to be 30.4375 days.
Outcome measures
| Measure |
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
n=4 Participants
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
n=7 Participants
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
n=10 Participants
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
n=2 Participants
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Duration of Response, as Assessed Using irRECIST
|
15.61 months
Interval 1.18 to
Due to smaller number of participants with an event, the upper limit of 95% CI could not be calculated.
|
10.10 months
Interval 3.94 to
Due to smaller number of participants with an event, the upper limit of 95% CI could not be calculated.
|
25.49 months
Interval 4.6 to 25.49
|
7.33 months
Due to smaller number of participants with an event, the upper and lower limit of 95% CI could not be calculated.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start date of CR or PR to date of progression (up to 765 days)Population: FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Here, 'Overall number of participants analyzed' = participants who achieved objective response.
Duration of response was defined as number of months from start date of CR or PR (whichever occurred first) and subsequently confirmed, to the first date that recurrent or progressive disease was documented. CR: Disappearance of all target lesions and any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR: At least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, sum must also demonstrate an absolute increase of ≥5 mm; appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. For purposes of analysis, 1 month was considered to be 30.4375 days.
Outcome measures
| Measure |
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
n=2 Participants
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
n=7 Participants
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
n=8 Participants
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Duration of Response, as Assessed Using RECIST 1.1
|
NA months
Due to smaller number of participants with an event, median and upper and lower limit of 95% CI could not be calculated.
|
10.14 months
Interval 3.94 to
Due to smaller number of participants with an event, the upper limit of 95% CI could not be calculated.
|
25.49 months
Due to smaller number of participants with an event, the upper and lower limit of 95% CI could not be calculated.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization to date of PR or CR (up to 765 days)Population: FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Here, 'Overall number of participants analyzed' = participants who achieved objective response.
Time to response was defined as the number of months from the randomization date to the first date the participant achieved a PR or CR (whichever response occurred first and was subsequently confirmed). CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For purposes of analysis, 1 month was considered to be 30.4375 days.
Outcome measures
| Measure |
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
n=4 Participants
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
n=7 Participants
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
n=10 Participants
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
n=2 Participants
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Time to Response, as Assessed Using irRECIST
|
4.30 months
Interval 2.69 to 9.63
|
2.83 months
Interval 2.69 to 5.49
|
1.95 months
Interval 1.18 to 2.79
|
4.17 months
Interval 2.79 to 5.55
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization to date of PR or CR (up to 765 days)Population: FAS included all enrolled participants excluding those that did not receive at least 1 dose of entinostat and pembrolizumab or lacked baseline data. Here, 'Overall number of participants analyzed' = participants who achieved objective response.
Time to response was defined as the number of months from the randomization date to the first date the participant achieved a PR or CR (whichever response occurred first and was subsequently confirmed). CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For purposes of analysis, 1 month was considered to be 30.4375 days.
Outcome measures
| Measure |
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
n=2 Participants
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
n=7 Participants
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
n=8 Participants
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|---|---|---|---|---|---|---|---|
|
Phase 2: Time to Response, as Assessed Using RECIST 1.1
|
4.29 months
Interval 2.69 to 5.88
|
2.83 months
Interval 2.69 to 5.49
|
1.95 months
Interval 1.18 to 2.79
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 765 daysPopulation: Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs that started on or after the first administration of study drug and within 30 days of the last administration of any study treatment. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. For purposes of analysis, 1 month was considered to be 30.4375 days.
Outcome measures
| Measure |
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
n=6 Participants
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
n=7 Participants
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
n=9 Participants
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
n=18 Participants
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
n=76 Participants
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
n=53 Participants
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
n=38 Participants
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), AEs Resulting in the Permanent Discontinuation of Study Drug, and Death
TEAEs
|
6 Participants
|
7 Participants
|
9 Participants
|
18 Participants
|
75 Participants
|
53 Participants
|
37 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), AEs Resulting in the Permanent Discontinuation of Study Drug, and Death
SAEs
|
4 Participants
|
4 Participants
|
2 Participants
|
10 Participants
|
33 Participants
|
24 Participants
|
14 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), AEs Resulting in the Permanent Discontinuation of Study Drug, and Death
AEs Resulting in the Permanent Discontinuation of Study Drug
|
1 Participants
|
2 Participants
|
1 Participants
|
7 Participants
|
19 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), AEs Resulting in the Permanent Discontinuation of Study Drug, and Death
AEs Resulting in Death
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 21 (Cycle 1)Population: Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
A DLT was defined as the occurrence of any protocol-specified event in the first cycle of treatment (Day 1 through Day 21) of entinostat in combination with avelumab that were considered by the investigator to be at least possibly related to study drug.
Outcome measures
| Measure |
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
n=6 Participants
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
n=7 Participants
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
n=9 Participants
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|---|---|---|---|---|---|---|---|
|
Phase 1b: Number of Participants With at Least One Dose Limiting Toxicities (DLTs)
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 21 (Cycle 1)Population: Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
The RP2D was determined in discussion with the Sponsor, Medical Monitor, and Dose Determination Phase Investigators. Additionally, observations related to immune correlates, and any cumulative toxicity observed after multiple cycles might be included in the rationale supporting the RP2D. The RP2D could be equal to or less than the preliminary maximum tolerated dose (MTD). The MTD was defined as the highest dose level at which \<33% of 6 participants experienced DLT.
Outcome measures
| Measure |
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
n=22 Participants
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|---|---|---|---|---|---|---|---|
|
Phase 1b: Recommended Phase 2 Dose (RP2D)
|
5 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1b (Dose Escalation): Entinostat 3 mg Weekly + Pembrolizumab
Serious events: 4 serious events
Other events: 6 other events
Deaths: 6 deaths
Phase 1b (Dose Escalation): Entinostat 5 mg Weekly + Pembrolizumab
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 1b (Dose Confirmation): Entinostat 5 mg Weekly + Pembrolizumab
Serious events: 2 serious events
Other events: 9 other events
Deaths: 1 deaths
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
Serious events: 10 serious events
Other events: 18 other events
Deaths: 8 deaths
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
Serious events: 33 serious events
Other events: 75 other events
Deaths: 41 deaths
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
Serious events: 24 serious events
Other events: 52 other events
Deaths: 31 deaths
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
Serious events: 14 serious events
Other events: 37 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Phase 1b (Dose Escalation): Entinostat 3 mg Weekly + Pembrolizumab
n=6 participants at risk
Participants with NSCLC received entinostat 3 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 1b (Dose Escalation): Entinostat 5 mg Weekly + Pembrolizumab
n=7 participants at risk
Participants with NSCLC received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 1b (Dose Confirmation): Entinostat 5 mg Weekly + Pembrolizumab
n=9 participants at risk
Participants with NSCLC received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
n=18 participants at risk
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
n=76 participants at risk
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
n=53 participants at risk
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mgvia IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
n=38 participants at risk
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Death
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Face oedema
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Fatigue
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
4/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.9%
3/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
2/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
4/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Septic shock
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.9%
3/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Cardiac disorders
Pericardial effusion
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.9%
3/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Asthenia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Troponin I increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.7%
3/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Brain mass
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Hepatobiliary disorders
Steatohepatitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Vascular disorders
Embolism
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
Other adverse events
| Measure |
Phase 1b (Dose Escalation): Entinostat 3 mg Weekly + Pembrolizumab
n=6 participants at risk
Participants with NSCLC received entinostat 3 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 1b (Dose Escalation): Entinostat 5 mg Weekly + Pembrolizumab
n=7 participants at risk
Participants with NSCLC received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 1b (Dose Confirmation): Entinostat 5 mg Weekly + Pembrolizumab
n=9 participants at risk
Participants with NSCLC received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 1: Entinostat 5 mg Weekly + Pembrolizumab
n=18 participants at risk
Participants with NSCLC with squamous cell or adenocarcinoma histology who had not been treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 2: Entinostat 5 mg Weekly + Pembrolizumab
n=76 participants at risk
Participants with NSCLC (any histology) who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 3: Entinostat 5 mg Weekly + Pembrolizumab
n=53 participants at risk
Participants with melanoma who had previously been treated with and unequivocally progressed on either a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mgvia IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
Phase 2, Cohort 4: Entinostat 5 mg Weekly + Pembrolizumab
n=38 participants at risk
Participants with CRC (mismatch repair-proficient) who had not been previously treated with a PD-1- or PD-L1-blocking antibody, received entinostat 5 mg administered orally weekly (Days 1, 8, and 15 of each 21-day cycle) along with pembrolizumab 200 mg via IV infusion once every 3 weeks (Day 1 of each 21-day cycle).
|
|---|---|---|---|---|---|---|---|
|
Investigations
Weight decreased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
22.2%
2/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
2/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
26.3%
20/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
15.1%
8/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
26.3%
10/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
2/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
19.7%
15/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
15.1%
8/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
36.8%
14/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
22.2%
4/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
15.8%
12/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
17.0%
9/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
21.1%
8/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
2/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.8%
9/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
17.0%
9/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
23.7%
9/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
9.2%
7/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
13.2%
7/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
23.7%
9/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Fatigue
|
33.3%
2/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
85.7%
6/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
66.7%
6/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
77.8%
14/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
47.4%
36/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
54.7%
29/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
57.9%
22/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
16.7%
3/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
13.2%
10/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
18.9%
10/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Pyrexia
|
33.3%
2/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
16.7%
3/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.8%
9/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
17.0%
9/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Pain
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
28.6%
2/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
22.2%
2/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
16.7%
3/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
13.2%
10/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.5%
4/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Chills
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.9%
3/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
13.2%
7/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
10.5%
4/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
4/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
9.4%
5/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Chest pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
6.6%
5/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
9.4%
5/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Asthenia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
2/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
4/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Oedema
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
4/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.7%
3/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Malaise
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Mucosal inflammation
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.7%
3/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Localised oedema
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Face oedema
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Axillary pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Nodule
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Peripheral swelling
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Tenderness
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Early satiety
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Induration
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Infusion site bruising
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Swelling
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
General disorders
Temperature intolerance
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
33.3%
3/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
27.8%
5/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
27.6%
21/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
56.6%
30/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
23.7%
9/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
33.3%
3/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
27.8%
5/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
32.9%
25/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
37.7%
20/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
34.2%
13/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
33.3%
3/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
22.2%
4/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
19.7%
15/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
24.5%
13/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
21.1%
8/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
17.1%
13/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
30.2%
16/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
23.7%
9/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
10.5%
8/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
15.1%
8/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
28.9%
11/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
10.5%
8/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.7%
3/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
13.2%
5/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
33.3%
3/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
6.6%
5/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.7%
3/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.7%
3/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
2/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.7%
3/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.5%
4/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.7%
3/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Oedema mouth
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Gastrointestinal disorders
Reactive gastropathy
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
3/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
55.6%
5/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
16.7%
3/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
35.5%
27/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
30.2%
16/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
26.3%
10/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
22.2%
4/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
26.3%
20/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
26.4%
14/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
18.4%
7/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
16.7%
3/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
18.4%
14/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
18.9%
10/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
21.1%
8/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
42.9%
3/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
27.8%
5/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
25.0%
19/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.5%
4/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
10.5%
4/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
27.8%
5/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.5%
11/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
13.2%
7/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
2/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
9.2%
7/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.7%
3/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
13.2%
5/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
4/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
17.0%
9/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
2/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
4/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
6.6%
5/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
2/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.9%
3/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
2/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
18.9%
10/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
4/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
17.0%
9/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
6.6%
5/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
9.4%
5/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
13.2%
5/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
4/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.5%
4/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
6.6%
5/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.5%
4/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Weight increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Electrocardiogram QT interval
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
White blood cell count increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Antineutrophil cytoplasmic antibody decreased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Blood alkaline phosphatase
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Blood glucose increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Blood urea increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Carbon dioxide increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Differential white blood cell count abnormal
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Glucose urine present
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Platelet count
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Protein total decreased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Thyroxine free increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Tri-iodothyronine decreased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Investigations
Urine output decreased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
2/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
16.7%
3/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
22.4%
17/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
39.6%
21/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
21.1%
8/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
42.9%
3/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
33.3%
3/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
38.9%
7/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
19.7%
15/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
18.9%
10/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
15.8%
6/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
16.7%
3/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
4/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
2/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
4/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
28.6%
2/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
2/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
4/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
6/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.9%
3/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.7%
3/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
4/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.9%
3/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.9%
3/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Musculoskeletal and connective tissue disorders
|
33.3%
2/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
55.6%
10/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
44.7%
34/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
45.3%
24/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
44.7%
17/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Arthralgia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
27.8%
5/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
13.2%
10/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
15.1%
8/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
23.7%
9/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Back pain
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
16.7%
3/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
19.7%
15/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
15.1%
8/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Myalgia
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
42.9%
3/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
22.2%
4/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
4/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
13.2%
7/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
15.8%
6/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pain in extremity
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
16.7%
3/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
6.6%
5/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
9.4%
5/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Muscular weakness
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
6.6%
5/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
9.4%
5/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Muscle spasms
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
9.4%
5/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
10.5%
4/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Musculoskeletal pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
22.2%
2/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
6.6%
5/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.7%
3/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Neck pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.7%
3/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Groin pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.7%
3/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Musculoskeletal chest pain
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.9%
3/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Flank pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Joint swelling
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Bone pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Muscle atrophy
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pain in jaw
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Limb discomfort
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Muscle twitching
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Musculoskeletal discomfort
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Musculoskeletal stiffness
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Myopathy
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Myositis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Neck mass
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Osteonecrosis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Soft tissue disorder
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Spinal pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
28.6%
2/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
16.7%
3/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
28.9%
22/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
24.5%
13/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
34.2%
13/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
6/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
9.4%
5/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
9.4%
5/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
16.7%
3/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
6/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
24.5%
13/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
18.4%
7/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.8%
9/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
22.6%
12/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
15.8%
6/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.3%
6/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
10.5%
4/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.7%
3/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Orthostatic intolerance
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
42.9%
3/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
22.2%
4/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
6/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
22.6%
12/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
10.5%
4/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
2/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
15.1%
8/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
10.5%
4/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
4/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
13.2%
7/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
28.6%
2/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
16.7%
3/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.9%
3/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
9.4%
5/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.7%
3/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.5%
4/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.7%
3/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
6.6%
5/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
4/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
16.7%
3/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
4/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
9.4%
5/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
16.7%
3/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.9%
3/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.5%
4/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.9%
3/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Candida infection
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Fungal oesophagitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Infection
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Localised infection
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Oral infection
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Infections and infestations
Wound infection
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
2/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
6.6%
5/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
15.1%
8/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
13.2%
5/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
15.8%
6/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
2/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
10.5%
8/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.5%
4/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Vascular disorders
Embolism
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
2/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Vascular disorders
Penetrating atherosclerotic ulcer
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Vascular disorders
Poor venous access
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.9%
3/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
9.4%
5/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
6.6%
5/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
14.3%
1/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
2/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
4/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.5%
4/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.9%
3/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
9.4%
5/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.3%
2/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.9%
3/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Eye disorders
Diplopia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Eye disorders
Eye disorder
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Eye disorders
Visual impairment
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
11.1%
1/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.9%
3/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Endocrine disorders
Hyperthyroidism
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
7.9%
3/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
5.6%
1/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
2.6%
1/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Reproductive system and breast disorders
Vaginal lesion
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
3.8%
2/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Hepatobiliary disorders
Steatohepatitis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Surgical and medical procedures
Infection prophylaxis
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.3%
1/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Surgical and medical procedures
Sinus operation
|
16.7%
1/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
|
Surgical and medical procedures
Wound drainage
|
0.00%
0/6 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/7 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/9 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/18 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/76 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
1.9%
1/53 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
0.00%
0/38 • From first dose of study drug up to 765 days
Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or pembrolizumab.
|
Additional Information
Kate Madigan, MD, Chief Medical Officer
Syndax Pharmaceuticals, Inc.
Phone: 858-888-3798
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of the results of the multi-center Study shall not be made before the first multi-site publication by Sponsor or Publications Committee. No Public Presentation by Institution or Investigator will be made until Study Documentation/Results from all sites are received and analyzed by Sponsor. Separate publication by Investigator will be delayed for a period of 18 months until the initial publication by Committee or Sponsor, or a determination is made not to make such publication.
- Publication restrictions are in place
Restriction type: OTHER