Trial Outcomes & Findings for Safety & Efficacy Study of Combination of Pembrolizumab and Lenalidomide, in Patients With Relapsed Non-Hodgkin and Hodgkin Lymphoma (NCT NCT02875067)
NCT ID: NCT02875067
Last Updated: 2020-08-14
Results Overview
Assessing the number of drug related adverse events at each dose level of lenalidomide
TERMINATED
PHASE1/PHASE2
6 participants
up to 2 years
2020-08-14
Participant Flow
Participant milestones
| Measure |
Pembrolizumab and Lenalidomide
An intravenous infusion of 200 mg of pembrolizumab (MK3475) once every 3 weeks for a total of 4 infusions
Lenalidomide at either 15 mg, 10 mg or 20 mg (depending on which cohort patients are enrolled in) days 1-14 every 21 days
Pembrolizumab
Lenalidomide
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Pembrolizumab and Lenalidomide
An intravenous infusion of 200 mg of pembrolizumab (MK3475) once every 3 weeks for a total of 4 infusions
Lenalidomide at either 15 mg, 10 mg or 20 mg (depending on which cohort patients are enrolled in) days 1-14 every 21 days
Pembrolizumab
Lenalidomide
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Withdrawal by Termination of Study
|
5
|
Baseline Characteristics
Safety & Efficacy Study of Combination of Pembrolizumab and Lenalidomide, in Patients With Relapsed Non-Hodgkin and Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Pembrolizumab and Lenalidomide
n=6 Participants
An intravenous infusion of 200 mg of pembrolizumab (MK3475) once every 3 weeks for a total of 4 infusions
Lenalidomide at either 15 mg, 10 mg or 20 mg (depending on which cohort patients are enrolled in) days 1-14 every 21 days
Pembrolizumab
Lenalidomide
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 2 yearsPopulation: The study was terminated before formal data collection could occur.
Assessing the number of drug related adverse events at each dose level of lenalidomide
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: up to 2 yearsPopulation: The study was terminated before formal data collection could occur.
Assessment of lymphoma response (CR, PR or SD) and disease progression will be evaluated according to the Revised Response Criteria for Malignant Lymphoma. Overall response will be measured for all patients who complete one cycle of treatment
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: up to 2 yearsPopulation: The study was terminated before formal data collection could occur.
Assessment of lymphoma response (CR, PR or SD) and disease progression will be evaluated according to the Revised Response Criteria for Malignant Lymphoma. Overall response will be measured for all patients who complete one cycle of treatment
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: up to 2 yearsPopulation: The study was terminated before formal data collection could occur.
Assessment of lymphoma response (CR, PR or SD) and disease progression will be evaluated according to the Revised Response Criteria for Malignant Lymphoma. Overall response will be measured for all patients who complete one cycle of treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: The study was terminated before formal data collection could occur.
Assessment of lymphoma response (CR, PR or SD) and disease progression will be evaluated according to the Revised Response Criteria for Malignant Lymphoma. Overall response will be measured for all patients who complete one cycle of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: The study was terminated before formal data collection could occur.
Assessment of lymphoma response (CR, PR or SD) and disease progression will be evaluated according to the Revised Response Criteria for Malignant Lymphoma. Overall response will be measured for all patients who complete one cycle of treatment. Kaplan-Meir methodology will be used to estimate median PFS and Overall Survival (OS).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: The study was terminated before formal data collection could occur.
Assessment of lymphoma response (CR, PR or SD) and disease progression will be evaluated according to the Revised Response Criteria for Malignant Lymphoma. Overall response will be measured for all patients who complete one cycle of treatment. Kaplan-Meir methodology will be used to estimate median PFS and OS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: The study was terminated before formal data collection could occur.
Assessment of lymphoma response (CR, PR or SD) and disease progression will be evaluated according to the Revised Response Criteria for Malignant Lymphoma. Overall response will be measured for all patients who complete one cycle of treatment. Kaplan-Meir methodology will be used to estimate median PFS and OS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: The study was terminated before formal data collection could occur.
Assessment of lymphoma response (CR, PR or SD) and disease progression will be evaluated according to the Revised Response Criteria for Malignant Lymphoma. Overall response will be measured for all patients who complete one cycle of treatment. Kaplan-Meir methodology will be used to estimate median PFS and OS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: The study was terminated before formal data collection could occur.
Assessment of lymphoma response (CR, PR or SD) and disease progression will be evaluated according to the Revised Response Criteria for Malignant Lymphoma. Overall response will be measured for all patients who complete one cycle of treatment. Kaplan-Meir methodology will be used to estimate median PFS and OS.
Outcome measures
Outcome data not reported
Adverse Events
Pembrolizumab and Lenalidomide
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place