A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)
Completed · Phase 2
Conditions studied: Hematological Malignancies
In brief
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).
Key facts
- Study ID
- NCT05005442
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 192
- Starts
- 2021-09-28
- Expected to finish
- 2024-12-10
- Last updated by the study team
- 2026-02-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
- 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.
Where it is running
- 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
- City of Hope Comprehensive Cancer Center-Hematology ( Site 0024) — Duarte, California, United States
Full record on ClinicalTrials.gov
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