Phase 2
N=192
A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)
Hematological Malignancies
Bottom Line
View on ClinicalTrials.gov: NCT05005442 ↗Enrolled (actual)
192
Serious AEs
35.6%
Results posted
Dec 2025
Primary outcome: Primary: Percentage of Participants With a Dose-Limiting Toxicity (DLT) — 4.8; 2.4; 0.0; 5.0 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pembrolizumab/vibostolimab coformulation (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Dose-Limiting Toxicity (DLT) |
4.8; 2.4; 0.0; 5.0; 0.0; 8.0 | — |
| PRIMARY Percentage of Participants Who Experienced an Adverse Event (AE) |
92.9; 97.6; 95.0; 80.0; 80.0; 87.5 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Treatment Due to an AE |
19.0; 4.8; 15.0; 13.3; 4.0; 12.5 | — |
| SECONDARY Objective Response Rate (ORR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F) |
64.3; 35.7; 15.0; 16.7; 18.8 | — |
| SECONDARY ORR as Assessed by the 2016 International Myeloma Working Group (IMWG) Response Criteria (Cohort E) |
0.0 | — |
| SECONDARY Duration of Response (DOR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F) |
5.4; 3.0; 2.8; NA; 3.4 | — |
| SECONDARY DOR as Assessed by 2016 IMWG Response Criteria (Cohort E) |
— | — |
| SECONDARY Disease Control Rate (DCR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F) |
73.8; 59.5; 25.0; 16.7; 31.3 | — |
| SECONDARY DCR as Assessed by 2016 IMWG Response Criteria (Cohort E) |
16.0 | — |
| SECONDARY Lowest Plasma Concentration (Ctrough) of Vibostolimab |
8.06; 9.86; 10.0; 9.64; 9.86; 9.52 | — |
| SECONDARY Maximum Concentration (Cmax) of Vibostolimab |
85.8; 85.4; 42.6; 64.2; 53.2; 55.2 | — |
Summary
The purpose of the study is to determine the safety and tolerability of pembrolizumab/vibostolimab (MK-7684A) in hematological malignancies. This study will also evaluate the overall response rate (ORR), the duration of response (DOR), and disease control rate (DCR) following administration of pembrolizumab/vibostolimab. In addition, this study will characterize pharmacokinetic (PK) profile of vibostolimab (MK-7684).
Eligibility Criteria
Inclusion Criteria
- Have confirmed relapsed/refractory classic Hodgkins Lymphoma (cHL), Primary mediastinal B-cell lymphoma (PMBCL), Follicular Lymphoma (FL), Diffuse large B-cell lymphoma (DLBCL) or Non-Hodgkins Lymphoma (NHL), or multiple myeloma (MM).
For PMBCL, DLBCL, FL, and MM:
- Must be relapsed or refractory to CAR-T-cell therapy or unable to receive it.
For DLBCL and NHL:
- Must have exhausted or be ineligible for or intolerant to all treatments, which in the opinion of the investigator are standard of care for their disease.
For NHL:
- Participants with Mantle cell lymphoma (MCL) must have received prior Bruton's tyrosine kinase inhibitor therapy.
All participants:
- Have measurable disease.
- Have adequate organ function.
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation.
- Must be able to provide newly obtained bone marrow biopsy or aspirate material for disease assessment.
- Female participants are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of non child-bearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle.
Exclusion Criteria
For DLBCL and NHL:
- Has lymphoplasmacytic lymphomas, Waldenstrom's macroglobulinemia, chronic lymphocytic leukemia (not associated with small lymphocytic lymphoma), Burkitt (-like) lymphoma, mature T cell and NK cell neoplasms, immunodeficiency associated lymphoproliferative neoplasms, or histiocytic and dendritic cell neoplasms.
For MM:
- Has oligo-secretory myeloma, plasma cell leukemia, smoldering multiple myeloma, or monoclonal gammopathy of undetermined significance.
- Has a history of primary amyloidosis, hyperviscosity or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- Has known prior or current central nervous system (CNS) involvement.
For Epstein Barr virus (EBV) positive DLBCL:
- Associated with a solid organ transplant.
For all participants:
- A WOCBP who has a positive urine pregnancy test within 72 hours before study intervention allocation.
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.
- Has a history of a second malignancy.
- Any PMBCL participants that require the use of urgent cytoreductive therapy.
- If the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery before starting study intervention.
- Has received prior radiotherapy within 2 weeks of start of study intervention.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
- Has a known severe hypersensitivity to MK-7684A, vibostolimab or pembrolizumab and/or any of its excipients.
- Has a known history of Human Immunodeficiency Virus (HIV) infection.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has an active infection requiring systemic therapy.
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
- Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before enrollment.
- Has dual active HBV infection (HBsAg (+) and /or detectable HBV DNA) and Hepatitis C (HCV) infection (anti-HCV Ab (+) and detectable HC
Data sourced from ClinicalTrials.gov (NCT05005442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.