A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)
- Conditions
- Hematological Malignancies
- Interventions
- Biological: Pembrolizumab/vibostolimab coformuation
- Registration Number
- NCT05005442
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 191
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pembrolizumab/vibostolimab coformulation Pembrolizumab/vibostolimab coformuation 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.
- Primary Outcome Measures
Name Time Method Number of Participants with a Dose-Limiting Toxicity (DLT) Up to approximately 6 weeks 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). Number of participants who experience a DLT per CTCAE 5.0 will be reported.
Number of Participants Who Discontinued Study Treatment Due to an AE Up to approximately 24 months 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 will be reported.
Number of Participants Who Experienced an Adverse Event (AE) Up to approximately 27 months 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 will be reported.
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) Up to approximately 24 months ORR is defined as the percentage of participants who have a response as defined by the specific disease criteria of the hematological malignancy. The percentage of participants who experience a response will be presented.
Maximum Concentration (Cmax) of Vibostolimab Postdose: after end of infusion (up to ~10 minutes) at Cycles 1 and 8. Cycle = 3 weeks Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected post dose will be used to determine Cmax of Vibostolimab.
Lowest Plasma Concentration (Ctrough) of Vibostolimab Predose at Cycles 1, 2, 4, 8, and every 12 weeks afterwards (up to ~2 years). Cycle = 3 weeks Ctrough is the lowest concentration reached by a drug before the next dose is administered. Blood samples collected predose will be used to determine Ctrough of Vibostolimab.
Disease Control Rate (DCR) Up to approximately 24 months DCR is defined as the percentage of participants who have a Complete Response (CR), a Partial Response (PR), or Stable Disease (SD). The percentage of participants who experience a CR, a PR, or SD will be presented.
Duration of Response (DOR) Up to approximately 24 months DOR is the time from response (R) to progression/death (P/D). The DOR will be presented.
Trial Locations
- 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, Parana, Brazil
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