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).
Condition(s) studied
Investigational drug(s) / intervention(s)
Pembrolizumab: 400 mg or 200 mg pembrolizumab administered via IV infusion.
Pembrolizumab/Quavonlimab: Co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) fixed-dose combination (FDC) administered via IV infusion.
Pembrolizumab/Favezelimab: Co-formulated pembrolizumab/favezelimab (200 mg/800 mg) FDC administered via IV infusion
Pembrolizumab/Vibostolimab: Co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) FDC administered via IV infusion
MK-4830: 800 mg MK-4830 administered via IV infusion
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.
Eligibility
Primary outcome measure(s)
- Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) — Up to approximately 46 months
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.
Trial sites (109)
| Facility | City | Region | Status |
|---|---|---|---|
| Mid Florida Cancer Center ( Site 1519) | Orange City | Florida | |
| University Cancer & Blood Center, LLC ( Site 1521) | Athens | Georgia | |
| University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P | Chicago | Illinois | |
| Icahn School of Medicine at Mount Sinai ( Site 1528) | New York | New York | |
| Hematology Oncology Associates of Rockland ( Site 1525) | Nyack | New York | |
| UPMC Hillman Cancer Center ( Site 1516) | Pittsburgh | Pennsylvania | |
| The West Clinic, PLLC dba West Cancer Center ( Site 1576) | Germantown | Tennessee | |
| Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 1509) | Nashville | Tennessee | |
| UT Southwestern Medical Center ( Site 1551) | Dallas | Texas | |
| Baylor Scott & White Medical Center - Temple-Division of Hematology/Oncology ( Site 1549) | Temple | Texas | |
| Northwest Medical Specialties, PLLC ( Site 1546) | Tacoma | Washington | |
| UZ Brussel ( Site 0105) | Brussels | Bruxelles-Capitale, Region de | |
| Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0104) | Brussels | Bruxelles-Capitale, Region de | |
| Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0102) | Yvoir | Namur | |
| UZ Leuven ( Site 0101) | Leuven | Vlaams-Brabant | |
| AZ Delta vzw ( Site 0106) | Roeselare | West-Vlaanderen | |
| The Moncton Hospital-Oncology ( Site 0307) | Moncton | New Brunswick | |
| Sunnybrook Research Institute - Odette Cancer Centre ( Site 0316) | Toronto | Ontario | |
| McGill University Health Centre-CIM - Oncology ( Site 0306) | Montreal | Quebec | |
| Instituto de Cancerología ( Site 1610) | Medellín | Antioquia | |
| Fundación Colombiana de Cancerología Clínica Vida ( Site 1606) | Medellín | Antioquia | |
| Clinica de la Costa S.A.S. ( Site 1608) | Barranquilla | Atlántico | |
| Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 1611) | Bogotá | Bogota D.C. | |
| Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1601) | Valledupar | Cesar Department | |
| Oncomédica S.A.S ( Site 1602) | Montería | Departamento de Córdoba | |
| Mediservis del Tolima IPS S.A.S ( Site 1609) | Ibague | Tolima Department | |
| CIMCA-Hemato-Oncology ( Site 2101) | San José | Provincia de San José | |
| Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 2102) | Santa Ana | Provincia de San José | |
| Rigshospitalet ( Site 1904) | Copenhagen | Capital Region | |
| Regionshospitalet Gødstrup ( Site 1901) | Herning | Central Jutland | |
| Aalborg Universitetshospital, Syd ( Site 1903) | Aalborg | North Denmark | |
| Odense Universitetshospital ( Site 1902) | Odense | Region Syddanmark | |
| North Estonia Medical Centre Foundation-Chemotherapy ( Site 2301) | Tallinn | Harju | |
| Tartu University Hospital ( Site 2302) | Tartu | Tartu | |
| Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service d'Hepato-Gastro-Enterologie et | Marseille | Bouches-du-Rhone | |
| Centre Georges François Leclerc ( Site 0506) | Dijon | Cote-d Or | |
| CHU Rangueil-Digestive oncology department ( Site 0502) | Toulouse | Haute-Garonne | |
| Hopital Claude Huriez - CHU de Lille ( Site 0510) | Lille | Nord | |
| Centre Hospitalier Universitaire de Poitiers ( Site 0511) | Poitiers | Vienne | |
| Hôpital Saint Antoine-Oncologie médicale ( Site 0508) | Paris | France |
+ 69 more sites — see the full list on the official registry below.
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04895722 on ClinicalTrials.gov ↗ ← All trials in South Korea