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

NCT05005442 | Completed Phase 2 Results FDA Drug

• 4 other identifiers: 7684A-004MK-7684A-004KEYVIBE-0042021-001700-15
• Study Type: interventional
• Target: 192
• Locations: 16 countries
• Sites: 65

Brief 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).

Conditions

Hematological Malignancies

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With a Dose-Limiting Toxicity (DLT)

  A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Percentage of participants who experience a DLT per CTCAE 5.0 are reported.

  Up to approximately 6 weeks

• Percentage of Participants Who Experienced an Adverse Event (AE)

  An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants who experience an AE are reported.

  Up to approximately 27 months

• Percentage of Participants Who Discontinued Study Treatment Due to an AE

  An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants discontinued from the study treatment due to an AE are reported.

  Up to approximately 24 months

Secondary Outcomes (8)

• Objective Response Rate (ORR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F)

  Up to approximately 37 months

• ORR as Assessed by the 2016 International Myeloma Working Group (IMWG) Response Criteria (Cohort E)

  Up to approximately 37 months

• Duration of Response (DOR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F)

  Up to approximately 37 months

• DOR as Assessed by 2016 IMWG Response Criteria (Cohort E)

  Up to approximately 37 months

• Disease Control Rate (DCR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F)

  Up to approximately 37 months

Study Arms (1)

Pembrolizumab/vibostolimab coformulation

EXPERIMENTAL

Participants will receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.

Biological: Pembrolizumab/vibostolimab coformulation

Interventions

Pembrolizumab/vibostolimab coformulation BIOLOGICAL

Pembrolizumab 200 mg + vibostolimab 200 mg/20 mL vial IV infusion Q3W up to approximately 2 years.

Also known as: MK7684A

Pembrolizumab/vibostolimab coformulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (65)

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

Duarte, California, 91010, United States

Location

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

Aurora, Colorado, 80045, United States

Location

University of Chicago Medical Center ( Site 0005)

Chicago, Illinois, 60637, United States

Location

Henry Ford Hospital ( Site 0003)

Detroit, Michigan, 48202, United States

Location

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

Hackensack, New Jersey, 07601, United States

Location

Rutgers Cancer Institute of New Jersey ( Site 0023)

New Brunswick, New Jersey, 08901, United States

Location

University of Texas MD Anderson Cancer Center ( Site 0014)

Houston, Texas, 77030, United States

Location

Medical Oncology Associates, PS ( Site 0001)

Spokane, Washington, 99208, United States

Location

MEDICAL COLLEGE OF WISCONSIN ( Site 0016)

Milwaukee, Wisconsin, 53226, United States

Location

Instituto do Câncer e Transplante de Curitiba ( Site 0611)

Curitiba, Paraná, 80510130, Brazil

Location

Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0601)

Natal, Rio Grande do Norte, 59075-740, Brazil

Location

BC Cancer Vancouver ( Site 0034)

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0031)

Toronto, Ontario, m5g2m9, Canada

Location

Jewish General Hospital ( Site 0032)

Montreal, Quebec, H3T 1E2, Canada

Location

McGill University Health Centre ( Site 0037)

Montreal, Quebec, H4A 3J1, Canada

Location

Instituto Nacional del Cancer ( Site 0626)

Chile, Region M. de Santiago, 8380455, Chile

Location

FALP-UIDO ( Site 0623)

Santiago, Region M. de Santiago, 6900941, Chile

Location

Rigshospitalet-Hematology - CTU ( Site 0361)

Copenhagen, Capital Region, 2100, Denmark

Location

Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0362)

Aarhus, Central Jutland, 8200, Denmark

Location

Gustave Roussy-DITEP ( Site 0301)

Villejuif, Paris, 94800, France

Location

centre hospitalier lyon sud-Service Hématologie ( Site 0300)

Pierre-Bénite, Rhone, 69310, France

Location

Pitie Salpetriere University Hospital-Clinical haematology ( Site 0304)

Paris, 75013, France

Location

Universitätsklinikum Marburg ( Site 0333)

Marburg, Hesse, 35033, Germany

Location

Universitaetsklinikum Koeln-Klinik I für Innere Medizin ( Site 0321)

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Universitaetsklinikum Essen ( Site 0327)

Essen, North Rhine-Westphalia, 45122, Germany

Location

Klinikum Mutterhaus der Borromäerinnen-Innere Medizin I ( Site 0325)

Trier, Rhineland-Palatinate, 54290, Germany

Location

Universitätsklinikum Leipzig ( Site 0328)

Leipzig, Saxony, 04103, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf-II. medical clinic ( Site 0332)

Hamburg, 20246, Germany

Location

Pécsi Tudományegyetem Klinikai Központ-I.sz. Belgyógyászati Klinika Hematológia ( Site 0401)

Pécs, Baranya, 7624, Hungary

Location

Országos Onkológiai Intézet-HEMATOLÓGIA ÉS LYMPHOMA OSZTÁLY KEMOTERÁPIA A ( Site 0405)

Budapest, Pest County, 1122, Hungary

Location

Semmelweis University-Belgyógyászati és Hematológiai Klinika ( Site 0403)

Budapest, 1088, Hungary

Location

Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402)

Debrecen, 4032, Hungary

Location

Soroka Medical Center-Hematology Department ( Site 0523)

Beersheba, 8410101, Israel

Location

Rambam Health Care Campus ( Site 0526)

Haifa, 3109601, Israel

Location

Hadassah Medical Center ( Site 0522)

Jerusalem, 9112001, Israel

Location

Sheba Medical Center-Hemato Oncology ( Site 0524)

Ramat Gan, 5262100, Israel

Location

Sourasky Medical Center ( Site 0525)

Tel Aviv, 64239, Israel

Location

Fondazione Policlinico Universitario Agostino Gemelli-ISTITUTO DI EMATOLOGIA ( Site 0383)

Rome, Lazio, 00168, Italy

Location

Azienda Ospedaliera Spedali Civili di Brescia-Hemathology ( Site 0400)

Brescia, Lombardy, 25123, Italy

Location

Ospedale San Raffaele-Unità Linfomi ( Site 0382)

Milan, Lombardy, 20132, Italy

Location

Policlinico S. Orsola- Malpighi-Istituto di Ematologia "L. e A. Seragnoli" ( Site 0381)

Bologna, 40138, Italy

Location

Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site

Wrocaw, Lower Silesian Voivodeship, 50-556, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0424)

Gdansk, Pomeranian Voivodeship, 80-214, Poland

Location

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0427)

Gliwice, Silesian Voivodeship, 44-101, Poland

Location

GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0548)

Ufa, Baskortostan, Respublika, 450054, Russia

Location

Almazov National Medical Research Centre-Intensive care unit No. 10 for oncohematological patients (

Saint Petersburg, Leningradskaya Oblast', 197341, Russia

Location

Moscow City Clinical Hospital S.P. Botkin ( Site 0547)

Moscow, Moscow, 125284, Russia

Location

Russian Scientific Research Institute of Hematology and Blood Transfusion-Hematology ( Site 0542)

Saint Petersburg, Sankt-Peterburg, 191024, Russia

Location

Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 0442)

L'Hospitalet Del Llobregat, Barcelona, 08908, Spain

Location

Clinica Universidad de Navarra ( Site 0444)

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 0446)

Madrid, 28040, Spain

Location

Hospital Universitario de Salamanca-Hematology ( Site 0441)

Salamanca, 37007, Spain

Location

Chang Gung Memorial Hospital at Kaohsiung ( Site 0263)

Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch ( Site 0262)

Taoyuan District, 333, Taiwan

Location

Ege University Medicine of Faculty ( Site 0565)

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

Ankara University Hospital Cebeci ( Site 0561)

Ankara, 06100, Turkey (Türkiye)

Location

Mega Medipol-Hematology ( Site 0567)

Istanbul, 34214, Turkey (Türkiye)

Location

Vehbi Koc Vakfi - Amerikan Hastanesi ( Site 0562)

Istanbul, 34365, Turkey (Türkiye)

Location

Dokuz Eylül Üniversitesi-Hematology ( Site 0563)

Izmir, 35340, Turkey (Türkiye)

Location

Ondokuz Mayıs Universitesi ( Site 0564)

Samsun, 55139, Turkey (Türkiye)

Location

Cherkasy Regional Oncology Dispensary ( Site 0593)

Cherkassy, Cherkasy Oblast, 18009, Ukraine

Location

National Cancer Institute ( Site 0585)

Kyiv, Kyivska Oblast, 03022, Ukraine

Location

Institute of Transfusion Medicine and Blood of the National Academy of Medical Sciences of Ukraine (

Lviv, Lviv Oblast, 79044, Ukraine

Location

National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine (

Kyiv, Ukraine

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 13, 2021
• Study Start: September 28, 2021
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: February 19, 2026
• Results First Posted: December 17, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

ES (4); RU (4); UA (4); TW (2); DK (2); IL (5); DE (6); CA (4); TU (6); CL (2); HU (4); US (9); BR (2); IT (4); FR (3); PL (4)