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NCT04895722 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008)
A Phase 2 study of Colorectal Cancer, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 2
- Development phase
- 302
- Enrollment target
- 20
- Study locations
NCT04895722: Active Phase 2 study of Colorectal Cancer, sponsored by Merck Sharp & Dohme.
NCT04895722 is a Phase 2 study of Colorectal Cancer that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 302 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04895722, a Phase 2 study of Colorectal Cancer, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 302 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer.
Primary Outcome
ORR was defined as the percentage of participants who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed by BICR is presented.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL MK-4830
- BIOLOGICAL Pembrolizumab/Quavonlimab
- BIOLOGICAL Pembrolizumab/Favezelimab
- BIOLOGICAL Pembrolizumab/Vibostolimab
Study Locations (20)
New York
- Icahn School of Medicine at Mount Sinai ( Site 1528) - New York
- Hematology Oncology Associates of Rockland ( Site 1525) - Nyack
Tennessee
- The West Clinic, PLLC dba West Cancer Center ( Site 1576) - Germantown
- Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 1509) - Nashville
Texas
- UT Southwestern Medical Center ( Site 1551) - Dallas
- Baylor Scott & White Medical Center - Temple-Division of Hematology/Oncology ( Site 1549) - Temple
Bruxelles-Capitale, Region de
- UZ Brussel ( Site 0105) - Brussels
- Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0104) - Brussels
Florida
- Mid Florida Cancer Center ( Site 1519) - Orange City
Georgia
- University Cancer & Blood Center, LLC ( Site 1521) - Athens
Illinois
- University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P - Chicago
Pennsylvania
- UPMC Hillman Cancer Center ( Site 1516) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2021-06-25 |
| Est. Completion | 2026-08-13 |
| Phase | Phase 2 |
What the registry record for NCT04895722 still lists
NCT04895722 is an interventional study that assigns participants to a tested intervention. The registered 302 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04895722 names 20 study sites across 16 states, led by New York, Tennessee, Texas.
Frequently Asked Questions
What is clinical trial NCT04895722 about?
NCT04895722 is a clinical study titled "Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008)". The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer.
What is the current status of trial NCT04895722?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 302 participants. The study started on 2021-06-25. Estimated completion is 2026-08-13.
What conditions does trial NCT04895722 study?
This clinical trial studies the following conditions: Colorectal Cancer.
What interventions are being tested in trial NCT04895722?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), MK-4830 (BIOLOGICAL), Pembrolizumab/Quavonlimab (BIOLOGICAL), Pembrolizumab/Favezelimab (BIOLOGICAL), Pembrolizumab/Vibostolimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04895722?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04895722 being conducted?
This trial has 20 study locations across Florida, Georgia, Illinois, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04895722's enrollment target sits among peer trials
302 109th of 381 higher than 273 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer 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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