Efficacy and Safety Study of Pembrolizumab (MK-3475) in Combination With Daratumumab in Participants With Relapsed Refractory Multiple Myeloma (MK-3475-668/KEYNOTE-668)
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|ClinicalTrials.gov Identifier: NCT03221634|
Recruitment Status : Withdrawn (Business Reasons)
First Posted : July 18, 2017
Last Update Posted : March 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Biological: Pembrolizumab Biological: Daratumumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Pembrolizumab in Combination With Daratumumab (Anti CD38) in Participants With Relapsed Refractory Multiple Myeloma (rrMM)|
|Estimated Study Start Date :||August 1, 2017|
|Estimated Primary Completion Date :||March 20, 2019|
|Estimated Study Completion Date :||June 10, 2021|
Participants receive pembrolizumab 200 mg by intravenous (IV) infusion once every 3 weeks (Q3W) for up to 35 administrations (up to approximately 2 years) and receive daratumumab 16 mg/kg by IV infusion on Days 1, 8, 15, and 22 of Cycles 1-2; on Days 1 and 15 of Cycles 3-6, and on Day 1 of Cycle 7 and beyond, for up to 2 years. Each cycle is 28 days long.
Other Name: MK-3475
Other Name: DARZALEX®
- Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]ORR is defined as the percentage of participants who experience a partial response (PR; ≥50% reduction of serum myeloma (M)-protein plus reduction in 24-hour urinary M-protein by ≥90% or to <200 mg per 24 hours) or better per International Myeloma Working Group (IMWG) 2016, based on investigator assessment.
- Disease Control Rate (DCR) [ Time Frame: Up to approximately 2 years ]DCR is defined as the percentage of participants who experience stable disease (SD; not meeting criteria for complete response, very good partial response, partial response, minimal response or progressive disease) or better prior to any evidence of progression, per IMWG 2016 based on investigator assessment.
- Duration of Response (DOR) [ Time Frame: Up to approximately 2 years ]DOR is defined as the time from first documented evidence of at least a PR (≥50% reduction of serum M-protein plus reduction in 24-hour urinary M-protein by ≥90% or to <200 mg per 24 hours) until disease progression or death, per IMWG 2016, based on investigator assessment.
- Adverse Events (AEs) [ Time Frame: Up to approximately 27 months ]An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing one or more AEs will be assessed.
- Study Treatment Discontinuations Due to AEs [ Time Frame: Up to approximately 2 years ]The number of participants discontinuing study treatment due to AEs will be assessed.
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): NCT03221634
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|