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Phase 2 N=192 Treatment

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

Hematological Malignancies

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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