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ACTIVE NOT RECRUITING
NCT04895722
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Pembrolizumab

400 mg or 200 mg pembrolizumab administered via IV infusion.

BIOLOGICAL

Pembrolizumab/Quavonlimab

Co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) fixed-dose combination (FDC) administered via IV infusion.

BIOLOGICAL

Pembrolizumab/Favezelimab

Co-formulated pembrolizumab/favezelimab (200 mg/800 mg) FDC administered via IV infusion

BIOLOGICAL

Pembrolizumab/Vibostolimab

Co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) FDC administered via IV infusion

BIOLOGICAL

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