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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)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: A Phase 2, Multicenter, Multi Arm, Study to Evaluate MK-1308A (Co-formulated Quavonlimab (MK-1308)/Pembrolizumab) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer: (MK-1308A-008)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
302
Start Date
2021-06-25
Completion Date
2026-08-13
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
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
Locations (109)
Mid Florida Cancer Center ( Site 1519)
Orange City, Florida, United States
University Cancer & Blood Center, LLC ( Site 1521)
Athens, Georgia, United States
University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P
Chicago, Illinois, United States
Icahn School of Medicine at Mount Sinai ( Site 1528)
New York, New York, United States
Hematology Oncology Associates of Rockland ( Site 1525)
Nyack, New York, United States
UPMC Hillman Cancer Center ( Site 1516)
Pittsburgh, Pennsylvania, United States
The West Clinic, PLLC dba West Cancer Center ( Site 1576)
Germantown, Tennessee, United States
Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 1509)
Nashville, Tennessee, United States
UT Southwestern Medical Center ( Site 1551)
Dallas, Texas, United States
Baylor Scott & White Medical Center - Temple-Division of Hematology/Oncology ( Site 1549)
Temple, Texas, United States
Northwest Medical Specialties, PLLC ( Site 1546)
Tacoma, Washington, United States
UZ Brussel ( Site 0105)
Brussels, Bruxelles-Capitale, Region de, Belgium
Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0104)
Brussels, Bruxelles-Capitale, Region de, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0102)
Yvoir, Namur, Belgium
UZ Leuven ( Site 0101)
Leuven, Vlaams-Brabant, Belgium
AZ Delta vzw ( Site 0106)
Roeselare, West-Vlaanderen, Belgium
The Moncton Hospital-Oncology ( Site 0307)
Moncton, New Brunswick, Canada
Sunnybrook Research Institute - Odette Cancer Centre ( Site 0316)
Toronto, Ontario, Canada
McGill University Health Centre-CIM - Oncology ( Site 0306)
Montreal, Quebec, Canada
Instituto de Cancerología ( Site 1610)
Medellín, Antioquia, Colombia
Fundación Colombiana de Cancerología Clínica Vida ( Site 1606)
Medellín, Antioquia, Colombia
Clinica de la Costa S.A.S. ( Site 1608)
Barranquilla, Atlántico, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 1611)
Bogotá, Bogota D.C., Colombia
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1601)
Valledupar, Cesar Department, Colombia
Oncomédica S.A.S ( Site 1602)
Montería, Departamento de Córdoba, Colombia
Mediservis del Tolima IPS S.A.S ( Site 1609)
Ibagué, Tolima Department, Colombia
CIMCA-Hemato-Oncology ( Site 2101)
San José, Provincia de San José, Costa Rica
Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 2102)
Santa Ana, Provincia de San José, Costa Rica
Rigshospitalet ( Site 1904)
Copenhagen, Capital Region, Denmark
Regionshospitalet Gødstrup ( Site 1901)
Herning, Central Jutland, Denmark
Aalborg Universitetshospital, Syd ( Site 1903)
Aalborg, North Denmark, Denmark
Odense Universitetshospital ( Site 1902)
Odense, Region Syddanmark, Denmark
North Estonia Medical Centre Foundation-Chemotherapy ( Site 2301)
Tallinn, Harju, Estonia
Tartu University Hospital ( Site 2302)
Tartu, Tartu, Estonia
Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service d'Hepato-Gastro-Enterologie et
Marseille, Bouches-du-Rhone, France
Centre Georges François Leclerc ( Site 0506)
Dijon, Cote-d Or, France
CHU Rangueil-Digestive oncology department ( Site 0502)
Toulouse, Haute-Garonne, France
Hopital Claude Huriez - CHU de Lille ( Site 0510)
Lille, Nord, France
Centre Hospitalier Universitaire de Poitiers ( Site 0511)
Poitiers, Vienne, France
Hôpital Saint Antoine-Oncologie médicale ( Site 0508)
Paris, France
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie ( Site 0612)
Munich, Bavaria, Germany
Universitätsklinikum Marburg ( Site 0610)
Marburg, Hesse, Germany
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 0611)
Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 0601)
Dresden, Saxony, Germany
Otto-von-Guericke-Universität Magdeburg-Klinik für Gastroenterologie, Hepatologie und Infektiologie
Magdeburg, Saxony-Anhalt, 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, Attica, Greece
Evgenidion Hospital ( Site 2702)
Athens, Attica, Greece
University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 2703)
Heraklion, Irakleio, Greece
European Interbalkan Medical Center-Oncology Department ( Site 2701)
Thessaloniki, Greece
CELAN,S.A ( Site 2202)
Guatemala City, Guatemala
INTEGRA Cancer Institute-Oncology ( Site 2201)
Guatemala City, Guatemala
MEDI-K CAYALA ( Site 2205)
Guatemala City, Guatemala
Centro Regional de Sub Especialidades Médicas SA ( Site 2204)
Quetzaltenango, Guatemala
Centro Medico Integral De Cancerología (CEMIC) ( Site 2203)
Quetzaltenango, Guatemala
Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2009)
Pécs, Baranya, Hungary
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2005)
Kecskemét, Bács-Kiskun county, Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2001)
Szolnok, Jász-Nagykun-Szolnok, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 2010)
Kaposvár, Somogy County, Hungary
Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 2002)
Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 2008)
Debrecen, Hungary
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0802)
Milan, Lombardy, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale-Department of Abdominal Oncology ( Site 0803)
Naples, Italy
Istituto Oncologico Veneto IRCCS ( Site 0804)
Padova, Italy
Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 2402)
Kaunas, Kaunas County, Lithuania
National Cancer Institute ( Site 2401)
Vilnius, Vilniaus Miestas, Lithuania
VILNIUS UNIVERSITY HOSPITAL SANTAROS KLINIKOS ( Site 2403)
Vilnius, Lithuania
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 2901)
Amsterdam, North Holland, Netherlands
DOLNOSLASKIE CENTRUM ONKOLOGII PULMONOLOGII I HEMATOLOGII ( Site 0920)
Wroclaw, Lower Silesian Voivodeship, Poland
Luxmed Onkologia sp. z o. o. ( Site 0915)
Warsaw, Masovian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site
Warsaw, Masovian Voivodeship, Poland
Mrukmed-Mrukmed ( Site 0901)
Rzeszów, Podkarpackie Voivodeship, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0903)
Koszalin, West Pomeranian Voivodeship, Poland
Powiatowe Centrum Zdrowia ( Site 0911)
Brzeziny, Łódź Voivodeship, Poland
Spitalul de Oncologie Monza Oncologie Medicala ( Site 2601)
Bucharest, București, Romania
Fundeni Clinical Institute-Medical Oncology ( Site 2603)
Bucharest, București, Romania
Cardiomed SRL Cluj-Napoca ( Site 2602)
Cluj-Napoca, Cluj, Romania
Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2604)
Craiova, Dolj, Romania
Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1001)
Saint Petersburg, Leningradskaya Oblast', Russia
Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology-Clinical Pharmacology and Chemotherapy
Moscow, Moscow, Russia
First Moscow State Medical University I.M. Sechenov-Interhospital Institution Health Management Cl
Moscow, Moscow, Russia
Rostov Cancer Research Institute ( Site 1014)
Rostov-on-Don, Rostov Oblast, Russia
GBUZ SPb CRPCstmc(o) ( Site 1005)
Saint Petersburg, Sankt-Peterburg, Russia
Republican Clinical Oncology Dispensary-Chemotherapy #3 ( Site 1006)
Kazan', Tatarstan, Respublika, Russia
Kyungpook National University Chilgok Hospital-Hematology/oncology ( Site 1103)
Daegu, Taegu-Kwangyokshi, South Korea
Korea University Anam Hospital ( Site 1107)
Seoul, South Korea
Seoul National University Hospital-Internal Medicine ( Site 1101)
Seoul, South Korea
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1104)
Seoul, South Korea
Asan Medical Center-Department of Oncology ( Site 1105)
Seoul, South Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 1102)
Seoul, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital-Medical Oncology ( Site 1106)
Seoul, South Korea
Hospital Universitario Marqués de Valdecilla ( Site 1202)
Santander, Cantabria, Spain
Hospital Universitari Vall d'Hebron ( Site 1201)
Barcelona, Catalonia, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1206)
Madrid, Madrid, Comunidad de, Spain
H.R.U Malaga - Hospital General ( Site 1207)
Málaga, Malaga, Spain
COMPLEJO HOSPITALARIO DE NAVARRA-oncologia médica ( Site 1210)
Pamplona, Navarre, Spain
Hospital Universitario Central de Asturias-Medical Oncology ( Site 1203)
Oviedo, Principality of Asturias, Spain
Fundación Instituto Valenciano de Oncología ( Site 1209)
Valencia, Valenciana, Comunitat, Spain
Hospital Clinico San Carlos-Oncology Department ( Site 1204)
Madrid, Spain
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1303)
Adana, Turkey (Türkiye)
Hacettepe Universitesi-oncology hospital ( Site 1301)
Ankara, Turkey (Türkiye)
Ankara City Hospital-Medical Oncology ( Site 1306)
Ankara, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1302)
Istanbul, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1305)
Istanbul, Turkey (Türkiye)
Beatson West of Scotland Cancer Centre-Clinical Trials Unit ( Site 1401)
Glasgow, Glasgow City, United Kingdom
UCLH-Cancer Clinical Trials Unit ( Site 1402)
London-Camden, London, City of, United Kingdom
Velindre Cancer Centre-Research and Development ( Site 1415)
Cardiff, United Kingdom
University Hospital Coventry & Warwickshire ( Site 1406)
Coventry, United Kingdom