Trial Outcomes & Findings for Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian Cancer (NCT NCT02915523)
NCT ID: NCT02915523
Last Updated: 2024-01-10
Results Overview
PFS was defined as the number of months from randomization to progressive disease (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 millimeters (mm); the appearance of one or more new lesions; and unequivocal progression of existing non-target lesions.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
140 participants
Primary outcome timeframe
From date of randomization to PD or death due to any cause (maximum exposure: 24 cycles [each cycle = 14 days])
Results posted on
2024-01-10
Participant Flow
The study comprised 2 phases: an open-label Safety Lead-in (Phase 1b) and an Expansion Phase (Phase 2). Eligible participants were enrolled into Phase 1b or randomized into Phase 2 of the study within 3 days prior to starting study treatment on Cycle 1, Day 1.
Participant milestones
| Measure |
Phase 1B: Avelumab + Entinostat (3 mg)
Participants received entinostat 3 mg administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab intravenously (IV) once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 1B: Avelumab + Entinostat (5 mg)
Participants received entinostat 5 mg administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Placebo
Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Entinostat
Participants received entinostat at the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
|---|---|---|---|---|
|
Dose Determination Phase (Phase 1B)
STARTED
|
6
|
8
|
0
|
0
|
|
Dose Determination Phase (Phase 1B)
Received At Least 1 Dose Of Study Drug
|
6
|
8
|
0
|
0
|
|
Dose Determination Phase (Phase 1B)
Dose-limiting Toxicity (DLT) Evaluable
|
6
|
8
|
0
|
0
|
|
Dose Determination Phase (Phase 1B)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Dose Determination Phase (Phase 1B)
NOT COMPLETED
|
6
|
8
|
0
|
0
|
|
Expansion Phase (Phase 2)
STARTED
|
0
|
0
|
41
|
85
|
|
Expansion Phase (Phase 2)
Received At Least 1 Dose Of Study Drug
|
0
|
0
|
40
|
85
|
|
Expansion Phase (Phase 2)
COMPLETED
|
0
|
0
|
5
|
0
|
|
Expansion Phase (Phase 2)
NOT COMPLETED
|
0
|
0
|
36
|
85
|
Reasons for withdrawal
| Measure |
Phase 1B: Avelumab + Entinostat (3 mg)
Participants received entinostat 3 mg administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab intravenously (IV) once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 1B: Avelumab + Entinostat (5 mg)
Participants received entinostat 5 mg administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Placebo
Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Entinostat
Participants received entinostat at the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
|---|---|---|---|---|
|
Dose Determination Phase (Phase 1B)
Death
|
5
|
4
|
0
|
0
|
|
Dose Determination Phase (Phase 1B)
Sponsor Decision
|
1
|
3
|
0
|
0
|
|
Dose Determination Phase (Phase 1B)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Expansion Phase (Phase 2)
Death
|
0
|
0
|
26
|
53
|
|
Expansion Phase (Phase 2)
Sponsor Decision
|
0
|
0
|
4
|
22
|
|
Expansion Phase (Phase 2)
Withdrawal by Subject
|
0
|
0
|
6
|
8
|
|
Expansion Phase (Phase 2)
Lost to Follow-up
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Phase 1B: Avelumab + Entinostat (3 mg)
n=6 Participants
Participants received entinostat 3 mg administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 1B: Avelumab + Entinostat (5 mg)
n=8 Participants
Participants received entinostat 5 mg administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Placebo
n=41 Participants
Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Entinostat
n=85 Participants
Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<65 years
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
45 Participants
n=483 Participants
|
73 Participants
n=36 Participants
|
|
Age, Customized
≥65 years
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
67 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
85 Participants
n=483 Participants
|
140 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
80 Participants
n=483 Participants
|
131 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
79 Participants
n=483 Participants
|
130 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to PD or death due to any cause (maximum exposure: 24 cycles [each cycle = 14 days])Population: Full Analysis Set (FAS) included all participants who were randomized in Phase 2 by following the intent-to-treat principle.
PFS was defined as the number of months from randomization to progressive disease (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 millimeters (mm); the appearance of one or more new lesions; and unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Phase 2: Avelumab + Placebo
n=41 Participants
Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Entinostat
n=85 Participants
Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
|---|---|---|
|
Phase 2: Progression Free Survival (PFS), as Determined by the Local Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
1.51 months
Interval 1.45 to 2.5
|
1.64 months
Interval 1.41 to 2.69
|
PRIMARY outcome
Timeframe: Day 1 through Day 28 (Cycles 1 and 2)Population: Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
A DLT was defined as the occurrence of any protocol-specified event within the first 2 cycles of treatment (from Cycle 1 Day 1 through the end of Cycle 2) 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: Avelumab + Placebo
n=6 Participants
Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Entinostat
n=8 Participants
Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
|---|---|---|
|
Phase 1b: Number of Participants With at Least One Dose Limiting Toxicity (DLT) Adverse Event (AE)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 28 (Cycles 1 and 2)Population: Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
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: Avelumab + Placebo
n=14 Participants
Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Entinostat
Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
|---|---|---|
|
Phase 1b: Recommended Phase 2 Dose (RP2D)
|
5 mg
|
—
|
SECONDARY outcome
Timeframe: From date of randomization to PD or death due to any cause (maximum exposure: 24 cycles [each cycle = 14 days])Population: FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle.
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.
Outcome measures
| Measure |
Phase 2: Avelumab + Placebo
n=41 Participants
Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Entinostat
n=85 Participants
Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
|---|---|---|
|
Phase 2: PFS, as Determined by the Local Investigator Using Immune Response RECIST (irRECIST)
|
2.10 months
Interval 1.45 to 2.79
|
1.77 months
Interval 1.45 to 2.69
|
SECONDARY outcome
Timeframe: From date of randomization to date of progression (maximum exposure: 24 cycles [each cycle = 14 days])Population: FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle.
The ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR). 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.
Outcome measures
| Measure |
Phase 2: Avelumab + Placebo
n=41 Participants
Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Entinostat
n=85 Participants
Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
|---|---|---|
|
Phase 2: Objective Response Rate (ORR), as Assessed Using RECIST 1.1
|
4.88 percentage of participants
Interval 0.6 to 16.53
|
5.88 percentage of participants
Interval 1.94 to 13.2
|
SECONDARY outcome
Timeframe: From date of randomization to date of progression (maximum exposure: 24 cycles [each cycle = 14 days])Population: FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle.
The ORR was defined as the percentage of participants with confirmed CR or 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 mm. PR: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%.
Outcome measures
| Measure |
Phase 2: Avelumab + Placebo
n=41 Participants
Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Entinostat
n=85 Participants
Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
|---|---|---|
|
Phase 2: ORR, as Assessed Using irRECIST
|
2.44 percentage of participants
Interval 0.06 to 12.86
|
4.71 percentage of participants
Interval 1.3 to 11.61
|
SECONDARY outcome
Timeframe: From date of randomization to date of progression (maximum exposure: 24 cycles [each cycle = 14 days])Population: FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle.
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: 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: Avelumab + Placebo
n=41 Participants
Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Entinostat
n=85 Participants
Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
|---|---|---|
|
Phase 2: Clinical Benefit Rate (CBR), as Assessed Using RECIST 1.1
|
9.76 percentage of participants
Interval 2.72 to 23.13
|
11.76 percentage of participants
Interval 5.79 to 20.57
|
SECONDARY outcome
Timeframe: From date of randomization to date of progression (maximum exposure: 24 cycle [each cycle = 14 days])Population: FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle.
The CBR was defined as the percentage of participants with a confirmed CR, PR, or 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 PD (compared to nadir).
Outcome measures
| Measure |
Phase 2: Avelumab + Placebo
n=41 Participants
Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Entinostat
n=85 Participants
Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
|---|---|---|
|
Phase 2: CBR, as Assessed Using irRECIST
|
9.76 percentage of participants
Interval 2.72 to 23.13
|
9.41 percentage of participants
Interval 4.15 to 17.71
|
SECONDARY outcome
Timeframe: From date of randomization to the date of death (maximum exposure: 24 cycles [each cycle = 14 days])Population: FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle.
Overall survival was defined as the number of months from randomization to the date of death (due to any cause).
Outcome measures
| Measure |
Phase 2: Avelumab + Placebo
n=41 Participants
Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Entinostat
n=85 Participants
Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
|---|---|---|
|
Phase 2: Overall Survival
|
10.55 months
Interval 6.41 to 16.72
|
12.85 months
Interval 9.53 to 18.37
|
SECONDARY outcome
Timeframe: From start date of CR or PR to date of progression (maximum exposure: 24 cycles [each cycle = 14 days])Population: FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle and had a response (achieved objective response: complete response or partial response).
Duration of response was defined as the number of months from the start date of PR or CR (whichever response 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 (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. 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.
Outcome measures
| Measure |
Phase 2: Avelumab + Placebo
n=2 Participants
Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Entinostat
n=5 Participants
Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
|---|---|---|
|
Phase 2: Duration of Response
|
6.83 months
Interval 4.14 to
Due to smaller number of participants with an event, upper limit of 95 % confidence interval (CI) could not be calculated.
|
4.21 months
Interval 2.17 to 16.59
|
SECONDARY outcome
Timeframe: From the date of randomization to date of PR or CR (maximum exposure: 24 cycles [each cycle = 14 days])Population: FAS included all participants who were randomized in Phase 2 by following the intent-to-treat principle and had a response (achieved objective response: complete response or partial 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.
Outcome measures
| Measure |
Phase 2: Avelumab + Placebo
n=2 Participants
Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Entinostat
n=5 Participants
Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
|---|---|---|
|
Phase 2: Time to Response
|
2.10 months
Interval 1.38 to 2.83
|
2.79 months
Interval 1.35 to 4.17
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])Population: Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
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'.
Outcome measures
| Measure |
Phase 2: Avelumab + Placebo
n=6 Participants
Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Entinostat
n=8 Participants
Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
|---|---|---|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), AEs Resulting in the Permanent Discontinuation of Study Drug, and Death
Any TEAEs
|
6 Participants
|
8 Participants
|
|
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), AEs Resulting in the Permanent Discontinuation of Study Drug, and Death
Death
|
1 Participants
|
0 Participants
|
|
Phase 1b: 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
|
1 Participants
|
4 Participants
|
|
Phase 1b: 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
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])Population: Safety analysis set included all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
An 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'.
Outcome measures
| Measure |
Phase 2: Avelumab + Placebo
n=40 Participants
Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Entinostat
n=85 Participants
Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
|---|---|---|
|
Phase 2: Number of Participants With TEAEs, SAEs, AEs Resulting in the Permanent Discontinuation of Study Drug, and Death
Any TEAEs
|
39 Participants
|
85 Participants
|
|
Phase 2: Number of Participants With TEAEs, SAEs, AEs Resulting in the Permanent Discontinuation of Study Drug, and Death
Death
|
1 Participants
|
1 Participants
|
|
Phase 2: Number of Participants With TEAEs, SAEs, AEs Resulting in the Permanent Discontinuation of Study Drug, and Death
SAEs
|
17 Participants
|
39 Participants
|
|
Phase 2: Number of Participants With TEAEs, SAEs, AEs Resulting in the Permanent Discontinuation of Study Drug, and Death
AEs Resulting in the Permanent Discontinuation of Study Drug
|
6 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Pre-dose and post-infusion on Day 1 of Cycle 1 the 30-day follow-up (maximum exposure: 24 cycles [each cycle = 14 days])Population: Analysis was not performed as data were not collected for this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1B: Avelumab + Entinostat (3 mg)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 5 deaths
Phase 1B: Avelumab + Entinostat (5 mg)
Serious events: 4 serious events
Other events: 8 other events
Deaths: 4 deaths
Phase 2: Avelumab + Placebo
Serious events: 17 serious events
Other events: 39 other events
Deaths: 26 deaths
Phase 2: Avelumab + Entinostat
Serious events: 39 serious events
Other events: 85 other events
Deaths: 54 deaths
Serious adverse events
| Measure |
Phase 1B: Avelumab + Entinostat (3 mg)
n=6 participants at risk
Participants received entinostat 3 mg administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 1B: Avelumab + Entinostat (5 mg)
n=8 participants at risk
Participants received entinostat 5 mg administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Placebo
n=40 participants at risk
Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Entinostat
n=85 participants at risk
Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Nervous system disorders
Myasthenic syndrome
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.5%
3/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.9%
5/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
4.7%
4/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
3.5%
3/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
3.5%
3/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.4%
2/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.4%
2/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
3.5%
3/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.4%
2/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
General disorders
Asthenia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.4%
2/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.4%
2/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.4%
2/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.4%
2/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.4%
2/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Congenital, familial and genetic disorders
Cardiac failure congestive
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Infections and infestations
Cystitis klebsiella
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Infections and infestations
Device related infection
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
General disorders
Disease progression
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Vascular disorders
Embolism
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
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 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
Other adverse events
| Measure |
Phase 1B: Avelumab + Entinostat (3 mg)
n=6 participants at risk
Participants received entinostat 3 mg administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 1B: Avelumab + Entinostat (5 mg)
n=8 participants at risk
Participants received entinostat 5 mg administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Placebo
n=40 participants at risk
Participants received placebo matched to entinostat administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
Phase 2: Avelumab + Entinostat
n=85 participants at risk
Participants received entinostat at the MTD/ RP2D (as determined in the Phase IB part of the study) administered orally weekly (Days 1 and 8 of each 14-day cycle) in combination with avelumab IV once every 2 weeks (Day 1 of each 14-day cycle).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
75.0%
6/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
37.5%
15/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
43.5%
37/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
3/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
25.0%
2/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
27.5%
11/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
40.0%
34/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
30.0%
12/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
32.9%
28/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
25.0%
2/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
27.5%
11/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
27.1%
23/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
50.0%
4/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
27.5%
11/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
28.2%
24/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Abdominal distension
|
50.0%
3/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
5/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
10.6%
9/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
15.0%
6/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
9.4%
8/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
15.0%
6/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
9.4%
8/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.5%
3/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
4.7%
4/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
10.0%
4/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
4.7%
4/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
10.0%
4/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
4.7%
4/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
3.5%
3/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
General disorders
Fatigue
|
33.3%
2/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
75.0%
6/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
42.5%
17/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
60.0%
51/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.5%
3/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
28.2%
24/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
General disorders
Chills
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
5/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
24.7%
21/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
10.0%
4/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
14.1%
12/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
General disorders
Asthenia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
10.0%
4/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.4%
2/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
General disorders
Pain
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
10.0%
4/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
4.7%
4/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.9%
5/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
General disorders
Early satiety
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
3.5%
3/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
General disorders
Malaise
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
4.7%
4/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
4/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
75.0%
6/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
17.5%
7/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
25.9%
22/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
5/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
21.2%
18/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
22.4%
19/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.5%
3/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
16.5%
14/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.5%
3/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
10.6%
9/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.9%
11/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
16.5%
14/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
8.2%
7/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
4.7%
4/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.4%
2/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
2/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
17.5%
7/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
23.5%
20/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
20.0%
8/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
20.0%
17/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
9.4%
8/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.9%
5/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.5%
3/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.9%
5/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.5%
3/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.9%
5/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
10.0%
4/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.5%
3/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
15.0%
6/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
15.3%
13/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
2/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.5%
3/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
14.1%
12/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
25.0%
2/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
17.5%
7/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.1%
6/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
9.4%
8/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.1%
6/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.5%
3/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
3.5%
3/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
4.7%
4/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
22.5%
9/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
28.2%
24/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
18.8%
16/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.9%
11/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
4.7%
4/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
25.0%
2/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
5/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
9.4%
8/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
11.8%
10/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.9%
11/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
5/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
8.2%
7/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
9.4%
8/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
3.5%
3/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.9%
5/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
25.0%
2/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
20.0%
8/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.9%
11/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
21.2%
18/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.9%
5/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
10.0%
4/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
9.4%
8/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.5%
3/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
3.5%
3/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.5%
3/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
8.2%
7/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.4%
2/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.5%
3/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
8.2%
7/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
10.0%
4/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.9%
5/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.9%
5/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
3.5%
3/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
25.0%
2/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
10.0%
4/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
8.2%
7/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.1%
6/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
10.0%
4/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.1%
6/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.5%
3/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.1%
6/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.9%
5/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.9%
5/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
15.0%
6/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.9%
5/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
25.0%
2/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.5%
3/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
8.2%
7/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.5%
3/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.4%
2/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
25.0%
2/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
4.7%
4/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.4%
2/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.5%
3/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
7.5%
3/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
4.7%
4/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
5.0%
2/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
3.5%
3/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
25.0%
2/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
3.5%
3/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.4%
2/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
General disorders
Peripheral swelling
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
4.7%
4/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Investigations
Breath sounds abnormal
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Investigations
Weight increased
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.4%
2/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Musculoskeletal and connective tissue disorders
Connective tissue disorder
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
3.5%
3/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
3.5%
3/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.5%
1/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Nervous system disorders
Restless legs syndrome
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
2.4%
2/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Endocrine disorders
Steroid withdrawal syndrome
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Infections and infestations
Pharyngitis
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
3.5%
3/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Injury, poisoning and procedural complications
Scratch
|
16.7%
1/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
12.5%
1/8 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
0.00%
0/40 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
1.2%
1/85 • From first dose of study drug up to 30 days after end of treatment (maximum exposure: 24 cycles [each cycle = 14 days])
Deaths were assessed for all participants enrolled in Phase 1b and randomized to treatment in Part 2. AEs were assessed for all participants who received at least 1 dose of either study drug, entinostat, or avelumab.
|
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