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A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)

A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of MK-7684A (MK-7684 [Vibostolimab] With MK-3475 [Pembrolizumab] Coformulation) in Participants With Relapsed or Refractory Hematological Malignancies

NCT05005442•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

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.
+15 more criteria

Locations (65)

City of Hope Comprehensive Cancer Center-Hematology ( Site 0024)

Duarte, California, United States

University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0021

Aurora, Colorado, United States

University of Chicago Medical Center ( Site 0005)

Chicago, Illinois, United States

Henry Ford Hospital ( Site 0003)

Detroit, Michigan, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)

Hackensack, New Jersey, United States

Rutgers Cancer Institute of New Jersey ( Site 0023)

New Brunswick, New Jersey, United States

University of Texas MD Anderson Cancer Center ( Site 0014)

Houston, Texas, United States

Medical Oncology Associates, PS ( Site 0001)

Spokane, Washington, United States

MEDICAL COLLEGE OF WISCONSIN ( Site 0016)

Milwaukee, Wisconsin, United States

Instituto do Câncer e Transplante de Curitiba ( Site 0611)

Curitiba, Paraná, Brazil

Key Dates

Start Date

September 28, 2021

Primary Completion Date

December 10, 2024

Completion Date

December 10, 2024

Last Updated

February 19, 2026

Enrollment

192

ACTUAL participants

Conditions

Hematological Malignancies

Interventions

Pembrolizumab/vibostolimab coformulation

BIOLOGICAL

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RECRUITING

18F-Pentixafor PET in Hematologic Malignancies

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Hematological Malignancies

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)

Inclusion Criteria

Exclusion Criteria

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