A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)
NCT ID: NCT05005442
Last Updated: 2025-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
192 participants
INTERVENTIONAL
2021-09-28
2024-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pembrolizumab/vibostolimab coformulation
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.
Pembrolizumab/vibostolimab coformulation
Pembrolizumab 200 mg + vibostolimab 200 mg/20 mL vial IV infusion Q3W up to approximately 2 years.
Interventions
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Pembrolizumab/vibostolimab coformulation
Pembrolizumab 200 mg + vibostolimab 200 mg/20 mL vial IV infusion Q3W up to approximately 2 years.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
\- 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 HCV RNA) at study entry..
* Has had an allogenic hematopoietic stem cell/solid organ transplantation within the last 5 years.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0601)
Natal, Rio Grande do Norte, Brazil
BC Cancer Vancouver ( Site 0034)
Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0031)
Toronto, Ontario, Canada
Jewish General Hospital ( Site 0032)
Montreal, Quebec, Canada
McGill University Health Centre ( Site 0037)
Montreal, Quebec, Canada
Instituto Nacional del Cancer ( Site 0626)
Chile, Region M. de Santiago, Chile
FALP-UIDO ( Site 0623)
Santiago, Region M. de Santiago, Chile
Rigshospitalet-Hematology - CTU ( Site 0361)
Copenhagen, Capital Region, Denmark
Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0362)
Aarhus, Central Jutland, Denmark
Gustave Roussy-DITEP ( Site 0301)
Villejuif, Paris, France
centre hospitalier lyon sud-Service Hématologie ( Site 0300)
Pierre-Bénite, Rhone, France
Pitie Salpetriere University Hospital-Clinical haematology ( Site 0304)
Paris, , France
Universitätsklinikum Marburg ( Site 0333)
Marburg, Hesse, Germany
Universitaetsklinikum Koeln-Klinik I für Innere Medizin ( Site 0321)
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen ( Site 0327)
Essen, North Rhine-Westphalia, Germany
Klinikum Mutterhaus der Borromäerinnen-Innere Medizin I ( Site 0325)
Trier, Rhineland-Palatinate, Germany
Universitätsklinikum Leipzig ( Site 0328)
Leipzig, Saxony, Germany
Universitaetsklinikum Hamburg-Eppendorf-II. medical clinic ( Site 0332)
Hamburg, , Germany
Pécsi Tudományegyetem Klinikai Központ-I.sz. Belgyógyászati Klinika Hematológia ( Site 0401)
Pécs, Baranya, Hungary
Országos Onkológiai Intézet-HEMATOLÓGIA ÉS LYMPHOMA OSZTÁLY KEMOTERÁPIA A ( Site 0405)
Budapest, Pest County, Hungary
Semmelweis University-Belgyógyászati és Hematológiai Klinika ( Site 0403)
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402)
Debrecen, , Hungary
Soroka Medical Center-Hematology Department ( Site 0523)
Beersheba, , Israel
Rambam Health Care Campus ( Site 0526)
Haifa, , Israel
Hadassah Medical Center ( Site 0522)
Jerusalem, , Israel
Sheba Medical Center-Hemato Oncology ( Site 0524)
Ramat Gan, , Israel
Sourasky Medical Center ( Site 0525)
Tel Aviv, , Israel
Fondazione Policlinico Universitario Agostino Gemelli-ISTITUTO DI EMATOLOGIA ( Site 0383)
Rome, Lazio, Italy
Azienda Ospedaliera Spedali Civili di Brescia-Hemathology ( Site 0400)
Brescia, Lombardy, Italy
Ospedale San Raffaele-Unità Linfomi ( Site 0382)
Milan, Lombardy, Italy
Policlinico S. Orsola- Malpighi-Istituto di Ematologia "L. e A. Seragnoli" ( Site 0381)
Bologna, , Italy
Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site
Wrocaw, Lower Silesian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0424)
Gdansk, Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0427)
Gliwice, Silesian Voivodeship, Poland
GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0548)
Ufa, Baskortostan, Respublika, Russia
Almazov National Medical Research Centre-Intensive care unit No. 10 for oncohematological patients (
Saint Petersburg, Leningradskaya Oblast', Russia
Moscow City Clinical Hospital S.P. Botkin ( Site 0547)
Moscow, Moscow, Russia
Russian Scientific Research Institute of Hematology and Blood Transfusion-Hematology ( Site 0542)
Saint Petersburg, Sankt-Peterburg, Russia
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 0442)
L'Hospitalet Del Llobregat, Barcelona, Spain
Clinica Universidad de Navarra ( Site 0444)
Pamplona, Navarre, Spain
Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 0446)
Madrid, , Spain
Hospital Universitario de Salamanca-Hematology ( Site 0441)
Salamanca, , Spain
Chang Gung Memorial Hospital at Kaohsiung ( Site 0263)
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 0262)
Taoyuan District, , Taiwan
Ege University Medicine of Faculty ( Site 0565)
Bornova, İzmir, Turkey (Türkiye)
Ankara University Hospital Cebeci ( Site 0561)
Ankara, , Turkey (Türkiye)
Mega Medipol-Hematology ( Site 0567)
Istanbul, , Turkey (Türkiye)
Vehbi Koc Vakfi - Amerikan Hastanesi ( Site 0562)
Istanbul, , Turkey (Türkiye)
Dokuz Eylül Üniversitesi-Hematology ( Site 0563)
Izmir, , Turkey (Türkiye)
Ondokuz Mayıs Universitesi ( Site 0564)
Samsun, , Turkey (Türkiye)
Cherkasy Regional Oncology Dispensary ( Site 0593)
Cherkassy, Cherkasy Oblast, Ukraine
National Cancer Institute ( Site 0585)
Kyiv, Kyivska Oblast, Ukraine
Institute of Transfusion Medicine and Blood of the National Academy of Medical Sciences of Ukraine (
Lviv, Lviv Oblast, Ukraine
National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine (
Kyiv, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-7684A-004
Identifier Type: OTHER
Identifier Source: secondary_id
KEYVIBE-004
Identifier Type: OTHER
Identifier Source: secondary_id
2021-001700-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7684A-004
Identifier Type: -
Identifier Source: org_study_id