Brief 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.

Conditions

• Colorectal Cancer

Intervention / Treatment

• Biological: Pembrolizumab
• Biological: Pembrolizumab/Quavonlimab
• Biological: Pembrolizumab/Favezelimab
• Biological: Pembrolizumab/Vibostolimab
• Biological: MK-4830

Primary Outcome Measures

• 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.

Countries

Belgium, Canada, Colombia, Costa Rica, Denmark, Estonia, France, Germany, Greece, Guatemala, Hungary, Italy, Lithuania, Netherlands, Poland, Romania, Russia, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States

Locations and Investigators

• Mid Florida Cancer Center ( Site 1519), Orange City, United States
• University Cancer & Blood Center, LLC ( Site 1521), Athens, United States
• University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P, Chicago, United States
• Icahn School of Medicine at Mount Sinai ( Site 1528), New York, United States
• Hematology Oncology Associates of Rockland ( Site 1525), Nyack, United States
• UPMC Hillman Cancer Center ( Site 1516), Pittsburgh, United States
• The West Clinic, PLLC dba West Cancer Center ( Site 1576), Germantown, United States
• Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 1509), Nashville, United States
• UT Southwestern Medical Center ( Site 1551), Dallas, United States
• Baylor Scott & White Medical Center - Temple-Division of Hematology/Oncology ( Site 1549), Temple, United States
• Northwest Medical Specialties, PLLC ( Site 1546), Tacoma, United States
• UZ Brussel ( Site 0105), Brussels, Belgium
• Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0104), Brussels, Belgium
• Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0102), Yvoir, Belgium
• UZ Leuven ( Site 0101), Leuven, Belgium
• AZ Delta vzw ( Site 0106), Roeselare, Belgium
• The Moncton Hospital-Oncology ( Site 0307), Moncton, Canada
• Sunnybrook Research Institute - Odette Cancer Centre ( Site 0316), Toronto, Canada
• McGill University Health Centre-CIM - Oncology ( Site 0306), Montreal, Canada
• Instituto de Cancerología ( Site 1610), Medellín, Colombia
• Fundación Colombiana de Cancerología Clínica Vida ( Site 1606), Medellín, Colombia
• Clinica de la Costa S.A.S. ( Site 1608), Barranquilla, Colombia
• Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 1611), Bogotá, Colombia
• Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1601), Valledupar, Colombia
• Oncomédica S.A.S ( Site 1602), Montería, Colombia
• Mediservis del Tolima IPS S.A.S ( Site 1609), Ibague, Colombia
• CIMCA-Hemato-Oncology ( Site 2101), San José, Costa Rica
• Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 2102), Santa Ana, Costa Rica
• Rigshospitalet ( Site 1904), Copenhagen, Denmark
• Regionshospitalet Gødstrup ( Site 1901), Herning, Denmark
• Aalborg Universitetshospital, Syd ( Site 1903), Aalborg, Denmark
• Odense Universitetshospital ( Site 1902), Odense, Denmark
• North Estonia Medical Centre Foundation-Chemotherapy ( Site 2301), Tallinn, Estonia
• Tartu University Hospital ( Site 2302), Tartu, Estonia
• Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service d'Hepato-Gastro-Enterologie et, Marseille, France
• Centre Georges François Leclerc ( Site 0506), Dijon, France
• CHU Rangueil-Digestive oncology department ( Site 0502), Toulouse, France
• Hopital Claude Huriez - CHU de Lille ( Site 0510), Lille, France
• Centre Hospitalier Universitaire de Poitiers ( Site 0511), Poitiers, France
• Hôpital Saint Antoine-Oncologie médicale ( Site 0508), Paris, France
• Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie ( Site 0612), Munich, Germany
• Universitätsklinikum Marburg ( Site 0610), Marburg, Germany
• Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 0611), Essen, Germany
• Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 0601), Dresden, Germany
• Otto-von-Guericke-Universität Magdeburg-Klinik für Gastroenterologie, Hepatologie und Infektiologie, Magdeburg, Germany
• Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0604), Berlin, Germany
• Asklepios Altona-Oncology ( Site 0602), Hamburg, Germany
• Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 2704), Athens, Greece
• Evgenidion Hospital ( Site 2702), Athens, Greece
• University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 2703), Heraklion, Greece

And 59 other sites.

Study Officials

• Medical Director (Study Director) — Merck Sharp & Dohme LLC