Study of Pembrolizumab (MK-3475) in Combination With Dinaciclib (MK-7965) in Hematologic Malignancies (MK-3475-155)
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|ClinicalTrials.gov Identifier: NCT02684617|
Recruitment Status : Active, not recruiting
First Posted : February 18, 2016
Last Update Posted : May 8, 2019
This is a non-randomized, open-label study evaluating the safety and efficacy of pembrolizumab (MK-3475) used in combination with dinaciclib (MK-7965) in the treatment of relapsed or refractory chronic lymphocytic leukemia (rrCLL), multiple myeloma (rrMM), or diffuse large B-cell lymphoma (rrDLBCL) in up to 138 participants from multiple sites.
During an initial Dose Evaluation phase (first 2 cycles) to determine Dose Limiting Toxicities (DLTs), dose combinations of pembrolizumab 200 mg followed by dinaciclib 7 mg/m^2, pembrolizumab 200 mg followed by dinaciclib 10 mg/m^2, and pembrolizumab 200 mg followed by dinaciclib 14 mg/m^2 will be evaluated. Following safety review of the Dose Evaluation Phase, approximately 30 participants each will be enrolled in rrCLL, rrMM, or DLBCL cohorts during the Signal Detection phase. For each disease type objective response rate (ORR) will be determined by disease specific criteria.
The rrMM cohort was closed to enrollment on 07-AUG-2017 due to lack of efficacy.
|Condition or disease||Intervention/treatment||Phase|
|rrCLL rrMM rrDLBCL||Biological: pembrolizumab Drug: dinaciclib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||138 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib Trial of Pembrolizumab (MK-3475) in Combination With Dinaciclib (MK-7965) in Subjects With Hematologic Malignancies (KEYNOTE-155).|
|Actual Study Start Date :||March 29, 2016|
|Estimated Primary Completion Date :||February 6, 2020|
|Estimated Study Completion Date :||February 6, 2020|
Experimental: Pembrolizumab and Dinaciclib
During the Dose Evaluation phase of the study, 12 participants will receive an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7mg/m^2 on Cycle 1 Day 1 and infusion of dinaciclib 10 mg/m^2 alone on Cycle 1 Day 8. Participants will then receive an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14mg/m^2 on Day 1 and infusion of dinaciclib 14mg/m^2 alone on Day 8 on Cycles 2 through 35. The study design will be revised based on the number of DLTs in Cycle 1 and Cycle 2. If ≤4 DLTs occur, 30 participants per disease type will be enrolled in the Signal Detection Phase. If >5 DLTs occur, a lower dose will be evaluated in up to 24 additional participants.
200 mg administered as an intravenous (IV) infusion on Day 1 of infusion Cycles 1-35
dinaciclib 7 mg/m^2 administered as an IV infusion on Day 1 of infusion Cycle 1, dinaciclib 10 mg/m^2 administered as an IV infusion on Day 8 of infusion Cycle 1, dinaciclib 14 mg/m^2 administered as an IV infusion on Days 1 and 8 of infusion Cycles 2-35
Other Name: MK-7965
- Number of participants with Dose Limiting Toxicity (DLT) [ Time Frame: Cycles 1 and 2 (up to 42 days) ]
- Number of participants with Adverse Events (AEs) [ Time Frame: From time of first dose until the end of follow-up (up to 26 months) ]
- Number of participants discontinuing study drug due to AEs [ Time Frame: From time of first dose until the end of follow-up (up to 26 months) ]
- Objective Response Rate (ORR) (disease specific) [ Time Frame: From time of screening until end of follow-up (up to 26 months) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684617
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|