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NCT05005442 · ClinicalTrials.gov registry record · Phase 2
A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)
A Phase 2 study of Hematological Malignancies, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 192
- Enrollment target
- 20
- Study locations
NCT05005442: Completed Phase 2 study of Hematological Malignancies, sponsored by Merck Sharp & Dohme.
NCT05005442 is a Phase 2 study of Hematological Malignancies that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 192 participants, below the 764-participant average among 16 other Hematological Malignancies trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05005442, a Phase 2 study of Hematological Malignancies, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 192 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab/vibostolimab coformulation
Study Locations (20)
New Jersey
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004) - Hackensack
- Rutgers Cancer Institute of New Jersey ( Site 0023) - New Brunswick
Quebec
- Jewish General Hospital ( Site 0032) - Montreal
- McGill University Health Centre ( Site 0037) - Montreal
Region M. de Santiago
- Instituto Nacional del Cancer ( Site 0626) - Chile
- FALP-UIDO ( Site 0623) - Santiago
California
- City of Hope Comprehensive Cancer Center-Hematology ( Site 0024) - Duarte
Colorado
- University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0021 - Aurora
Illinois
- University of Chicago Medical Center ( Site 0005) - Chicago
Michigan
- Henry Ford Hospital ( Site 0003) - Detroit
Texas
- University of Texas MD Anderson Cancer Center ( Site 0014) - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2021-09-28 |
| Est. Completion | 2024-12-10 |
| Phase | Phase 2 |
What the finished NCT05005442 record still lists
NCT05005442 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, below the 764-participant average among 16 other Hematological Malignancies trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Hematological Malignancies appearing as the primary indexed condition, and to 1 intervention - of which Pembrolizumab/vibostolimab coformulation is the first listed.
NCT05005442 names 20 study sites across 17 states, led by New Jersey, Quebec, Region M. de Santiago.
Frequently Asked Questions
What is clinical trial NCT05005442 about?
NCT05005442 is a clinical study titled "A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)". 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 pembr...
What is the current status of trial NCT05005442?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 192 participants. The study started on 2021-09-28. Estimated completion is 2024-12-10.
What conditions does trial NCT05005442 study?
This clinical trial studies the following conditions: Hematological Malignancies.
What interventions are being tested in trial NCT05005442?
The interventions under investigation include: Pembrolizumab/vibostolimab coformulation (BIOLOGICAL).
Who is sponsoring clinical trial NCT05005442?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05005442 being conducted?
This trial has 20 study locations across California, Colorado, Illinois, Michigan, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05005442's enrollment target sits among peer trials
192 7th of 16 higher than 10 of 16 other Hematological Malignancies trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematological Malignancies trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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