Trial Outcomes & Findings for Blinatumomab & Pembrolizumab for Adults With Relapsed/Refractory B-cell ALL With High Marrow Lymphoblasts (NCT NCT03160079)
NCT ID: NCT03160079
Last Updated: 2025-11-10
Results Overview
Best overall response rate (ORR) with the combination of blinatumomab and pembrolizumab in adult subjects with relapsed or refractory B-cell acute lymphoblastic leukemia will be defined as the Complete Response (CR) rate plus the Complete Response with Hematologic Recovery (CRh) rate after treatment of combination therapy. According to the National Comprehensive Cancer Network (NCCN) Guidelines for Acute Lymphoblastic Leukemia (version 1, 2015), CR is defined as \<5% lymphoblast in the bone marrow without evidence of circulating lymphoblasts or extramedullary disease. CRh is defined as for CR except with platelet count \>50,000/microliter, hemoglobin \>7 g/dL, and neutrophil (ANC) \>500/microliter.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
28 weeks
Results posted on
2025-11-10
Participant Flow
Participant milestones
| Measure |
Blinatumomab + Pembrolizumab
Drug: blinatumomab Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle length 42 days
Other Names:
Blincyto
Drug: pembrolizumab Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Other Names:
* Keytruda
* MK-3475
blinatumomab: Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle length 42 days
pembrolizumab: Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
|
Blinatumomab Only
Patients did not receive Pembrolizumab due to early termination
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
4
|
|
Overall Study
Completed Course 1
|
8
|
4
|
|
Overall Study
Completed Course 2
|
5
|
0
|
|
Overall Study
Completed Course 3
|
3
|
0
|
|
Overall Study
Completed Course 4
|
1
|
0
|
|
Overall Study
Completed Course 5
|
1
|
0
|
|
Overall Study
COMPLETED
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Blinatumomab + Pembrolizumab
Drug: blinatumomab Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle length 42 days
Other Names:
Blincyto
Drug: pembrolizumab Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Other Names:
* Keytruda
* MK-3475
blinatumomab: Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle length 42 days
pembrolizumab: Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
|
Blinatumomab Only
Patients did not receive Pembrolizumab due to early termination
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Disease Progression
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Blinatumomab & Pembrolizumab for Adults With Relapsed/Refractory B-cell ALL With High Marrow Lymphoblasts
Baseline characteristics by cohort
| Measure |
Blinatumomab + Pembrolizumab
n=12 Participants
Drug: blinatumomab Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day) Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day) Cycle length 42 days
Other Names:
Blincyto Drug: pembrolizumab Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg) Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Other Names:
Keytruda MK-3475 blinatumomab: Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day) Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day) Cycle length 42 days pembrolizumab: Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg) Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
|
Blinatumomab Only
n=4 Participants
Patients did not receive Pembrolizumab due to early termination
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
3 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 28 weeksBest overall response rate (ORR) with the combination of blinatumomab and pembrolizumab in adult subjects with relapsed or refractory B-cell acute lymphoblastic leukemia will be defined as the Complete Response (CR) rate plus the Complete Response with Hematologic Recovery (CRh) rate after treatment of combination therapy. According to the National Comprehensive Cancer Network (NCCN) Guidelines for Acute Lymphoblastic Leukemia (version 1, 2015), CR is defined as \<5% lymphoblast in the bone marrow without evidence of circulating lymphoblasts or extramedullary disease. CRh is defined as for CR except with platelet count \>50,000/microliter, hemoglobin \>7 g/dL, and neutrophil (ANC) \>500/microliter.
Outcome measures
| Measure |
Blinatumomab + Pembrolizumab
n=12 Participants
Drug: blinatumomab Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle length 42 days
Other Names:
Blincyto
Drug: pembrolizumab Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Other Names:
* Keytruda
* MK-3475
blinatumomab: Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle length 42 days
pembrolizumab: Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
|
Blinatumomab Only
n=4 Participants
Patients did not receive Pembrolizumab due to early termination
|
|---|---|---|
|
Best Overall Response Rate (ORR)
Partial Response
|
1 Participants
|
0 Participants
|
|
Best Overall Response Rate (ORR)
Refractory
|
4 Participants
|
1 Participants
|
|
Best Overall Response Rate (ORR)
Not Evaluated
|
0 Participants
|
3 Participants
|
|
Best Overall Response Rate (ORR)
Complete Response (CR)
|
6 Participants
|
0 Participants
|
|
Best Overall Response Rate (ORR)
Complete Response with Hematologic Recovery
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 weeksCR is defined as \<5% lymphoblast in the bone marrow without evidence of circulating lymphoblasts or extramedullary disease.
Outcome measures
| Measure |
Blinatumomab + Pembrolizumab
n=12 Participants
Drug: blinatumomab Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle length 42 days
Other Names:
Blincyto
Drug: pembrolizumab Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Other Names:
* Keytruda
* MK-3475
blinatumomab: Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle length 42 days
pembrolizumab: Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
|
Blinatumomab Only
n=4 Participants
Patients did not receive Pembrolizumab due to early termination
|
|---|---|---|
|
Complete Response Rate (CR)
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 weeksPopulation: 7 participants received both Blinatumomab and Pembrolizumab and achieved a CR or CRh. Of the 7, 6 had achieved MRD negativity and 1 had unevaluable data. 2 participants received only Blinatumomab and achieved a CR or CRh, but neither had evaluable MRD data.
Minimal residual disease (MRD) negativity in subjects achieving a CR or CRh will be defined as less than 0.01% residual lymphoblasts by multiparameter flow cytometry.
Outcome measures
| Measure |
Blinatumomab + Pembrolizumab
n=7 Participants
Drug: blinatumomab Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle length 42 days
Other Names:
Blincyto
Drug: pembrolizumab Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Other Names:
* Keytruda
* MK-3475
blinatumomab: Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle length 42 days
pembrolizumab: Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
|
Blinatumomab Only
n=2 Participants
Patients did not receive Pembrolizumab due to early termination
|
|---|---|---|
|
Minimal Residual Disease (MRD) Negativity Rate in Subjects Achieving a CR or CRh
MRD negativity
|
6 Participants
|
0 Participants
|
|
Minimal Residual Disease (MRD) Negativity Rate in Subjects Achieving a CR or CRh
MRD not evaluable
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All participants who achieved a CR or CRh response were in the Blinatumomab + Pembrolizumab group. No participants in the Pembrolizumab Only group achieved a CR or CRh.
The number of patients achieving relapse free survival at 2 years. Relapse-free survival (RFS) will be defined as the time from achieving CR or CRh to relapse defined as the reappearance of lymphoblasts in bone marrow or blood at \>5% of cells or reappearance of extramedullary disease.
Outcome measures
| Measure |
Blinatumomab + Pembrolizumab
n=7 Participants
Drug: blinatumomab Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle length 42 days
Other Names:
Blincyto
Drug: pembrolizumab Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Other Names:
* Keytruda
* MK-3475
blinatumomab: Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle length 42 days
pembrolizumab: Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
|
Blinatumomab Only
Patients did not receive Pembrolizumab due to early termination
|
|---|---|---|
|
2 Year Relapse-free Survival Rate
|
2 participants
Interval 1.0 to 7.0
|
—
|
SECONDARY outcome
Timeframe: 2 yearsThe number of participants achieving survival at 2 years. 2-year overall survival (OS) will be defined as the time from starting study therapy to death from any cause.
Outcome measures
| Measure |
Blinatumomab + Pembrolizumab
n=12 Participants
Drug: blinatumomab Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle length 42 days
Other Names:
Blincyto
Drug: pembrolizumab Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Other Names:
* Keytruda
* MK-3475
blinatumomab: Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle length 42 days
pembrolizumab: Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
|
Blinatumomab Only
n=4 Participants
Patients did not receive Pembrolizumab due to early termination
|
|---|---|---|
|
2-year Overall Survival Rate
|
3 participants
Interval 2.55 to 4.95
|
1 participants
Interval 0.85 to 1.65
|
Adverse Events
Blinatumomab + Pembrolizumab
Serious events: 4 serious events
Other events: 12 other events
Deaths: 1 deaths
Blinatumomab Only
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Blinatumomab + Pembrolizumab
n=12 participants at risk
Patients who received both study drugs
|
Blinatumomab Only
n=4 participants at risk
Patients did not receive Pembrolizumab due to early termination
|
|---|---|---|
|
Immune system disorders
Cytokine Release Syndrome
|
8.3%
1/12 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
General disorders
Fever
|
8.3%
1/12 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Nervous system disorders
Seizure
|
8.3%
1/12 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
1/12 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Acute Disseminating Intravascular Coagulation
|
8.3%
1/12 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Macrophage Activation Syndrome
|
8.3%
1/12 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Nervous system disorders
Intracranial Hemorrhage/Hematoma
|
8.3%
1/12 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
General disorders
Neck Edema
|
8.3%
1/12 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
Other adverse events
| Measure |
Blinatumomab + Pembrolizumab
n=12 participants at risk
Patients who received both study drugs
|
Blinatumomab Only
n=4 participants at risk
Patients did not receive Pembrolizumab due to early termination
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
2/12 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
50.0%
2/4 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Investigations
Alanine aminotransaminase increased
|
33.3%
4/12 • Number of events 5 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Investigations
Alkaline Phosphatase Increase
|
25.0%
3/12 • Number of events 4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
4/12 • Number of events 14 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
3/12 • Number of events 3 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
50.0%
2/4 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Psychiatric disorders
Anxiety
|
33.3%
4/12 • Number of events 7 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Investigations
Aspartate Aminotransaminase Increased
|
33.3%
4/12 • Number of events 6 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
75.0%
3/4 • Number of events 3 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.7%
2/12 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Investigations
Blood Bilirubin Increased
|
25.0%
3/12 • Number of events 4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
General disorders
Non-cardiac chest pain
|
16.7%
2/12 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
General disorders
Chills
|
41.7%
5/12 • Number of events 5 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/12 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
50.0%
2/4 • Number of events 3 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
3/12 • Number of events 3 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Immune system disorders
Cytokine Release Syndrome
|
58.3%
7/12 • Number of events 14 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
75.0%
3/4 • Number of events 3 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
3/12 • Number of events 5 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
2/12 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
General disorders
Edema Limbs
|
8.3%
1/12 • Number of events 42 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Vascular disorders
Facial Flushing
|
16.7%
2/12 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
General disorders
Fatigue
|
41.7%
5/12 • Number of events 5 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
50.0%
2/4 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
25.0%
3/12 • Number of events 3 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
General disorders
Fever
|
50.0%
6/12 • Number of events 14 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
50.0%
2/4 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Endocrine disorders
Fluid Volume Overload
|
0.00%
0/12 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
50.0%
2/4 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Nervous system disorders
Headache
|
75.0%
9/12 • Number of events 11 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
8.3%
1/12 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.3%
1/12 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
16.7%
2/12 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
16.7%
2/12 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
2/12 • Number of events 5 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
1/12 • Number of events 3 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.3%
1/12 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
2/12 • Number of events 11 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.3%
1/12 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Vascular disorders
Hypotension
|
41.7%
5/12 • Number of events 6 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
1/12 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Psychiatric disorders
Insomnia
|
33.3%
4/12 • Number of events 5 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Leukocystosis
|
16.7%
2/12 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
1/12 • Number of events 3 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Number of events 9 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
83.3%
10/12 • Number of events 10 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Investigations
PLATELET COUNT DECREASED
|
16.7%
2/12 • Number of events 14 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Salivary duct inflammation
|
16.7%
2/12 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Nervous system disorders
Brachial plexopathy
|
0.00%
0/12 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/12 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
50.0%
2/4 • Number of events 5 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Cardiac disorders
Ventricular tachycardia
|
50.0%
6/12 • Number of events 7 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
50.0%
2/4 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Nervous system disorders
Vomiting
|
25.0%
3/12 • Number of events 3 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Investigations
White blood cell decreased
|
16.7%
2/12 • Number of events 8 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
0.00%
0/4 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Nervous system disorders
Aphonia
|
0.00%
0/12 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/12 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/12 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Nervous system disorders
Tremor
|
8.3%
1/12 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/12 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 2 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/12 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
25.0%
1/4 • Number of events 1 • 8 months (7 months on treatment and 30 days monitoring post last dose). Note that overall survival was monitored for 2 years, but Adverse Events were not monitored after 8 months.
Adverse events were collected via regular investigator assessments and regular laboratory testing.
|
Additional Information
Dr. James Mangan
University of California, San Diego, Moores Cancer Center
Phone: 858-822-6600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place