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)

May 9, 2024 updated by: Merck Sharp & Dohme LLC

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Bruxelles-Capitale, Region De
      • Brussels, Bruxelles-Capitale, Region De, Belgium, 1090
        • Recruiting
        • UZ Brussel ( Site 0105)
        • Contact:
          • Study Coordinator
          • Phone Number: 024749917
      • Brussels, Bruxelles-Capitale, Region De, Belgium, 1200
        • Recruiting
        • Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0104)
        • Contact:
          • Study Coordinator
          • Phone Number: 003227641041
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Recruiting
        • Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: +3281423857
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven ( Site 0101)
        • Contact:
          • Study Coordinator
          • Phone Number: 003216344218
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • Recruiting
        • AZ Delta vzw ( Site 0106)
        • Contact:
          • Study Coordinator
          • Phone Number: +3251237215
  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Recruiting
        • The Moncton Hospital-Oncology ( Site 0307)
        • Contact:
          • Study Coordinator
          • Phone Number: 506-857-5669
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute - Odette Cancer Centre ( Site 0316)
        • Contact:
          • Study Coordinator
          • Phone Number: 4162706506
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre-CIM - Oncology ( Site 0306)
        • Contact:
          • Study Coordinator
          • Phone Number: 514-934-1934x35161
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050030
        • Recruiting
        • Fundación Colombiana de Cancerología Clínica Vida ( Site 1606)
        • Contact:
          • Study Coordinator
          • Phone Number: 573147362301
      • Medellin, Antioquia, Colombia, 050025
        • Recruiting
        • Instituto de Cancerología ( Site 1610)
        • Contact:
          • Study Coordinator
          • Phone Number: 573206912418
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080020
        • Recruiting
        • Clinica de la Costa S.A.S. ( Site 1608)
        • Contact:
          • Study Coordinator
          • Phone Number: 5753369999
    • Cesar
      • Valledupar, Cesar, Colombia, 200001
        • Recruiting
        • Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1601)
        • Contact:
          • Study Coordinator
          • Phone Number: 57 3157411877
    • Cordoba
      • Montería, Cordoba, Colombia, 230002
        • Recruiting
        • Oncomédica S.A.S ( Site 1602)
        • Contact:
          • Study Coordinator
          • Phone Number: 57 3157962122
    • Distrito Capital De Bogota
      • Bogota, Distrito Capital De Bogota, Colombia, 111321
        • Recruiting
        • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 1611)
        • Contact:
          • Study Coordinator
          • Phone Number: 573138522112
    • Tolima
      • Ibague, Tolima, Colombia, 730006
        • Recruiting
        • Mediservis del Tolima IPS S.A.S ( Site 1609)
        • Contact:
          • Study Coordinator
          • Phone Number: +576082809432
  • Costa Rica
    • San Jose
      • San José, San Jose, Costa Rica, 1000
        • Recruiting
        • CIMCA-Hemato-Oncology ( Site 2101)
        • Contact:
          • Study Coordinator
          • Phone Number: 50683893636
      • Santa Ana, San Jose, Costa Rica, 10903
        • Recruiting
        • Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 2102)
        • Contact:
          • Study Coordinator
          • Phone Number: 50684978912
  • Denmark
    • Hovedstaden
      • Copenhagen, Hovedstaden, Denmark, 2100
        • Recruiting
        • Rigshospitalet ( Site 1904)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 35455909
    • Midtjylland
      • Herning, Midtjylland, Denmark, 7400
        • Recruiting
        • Regionshospitalet Gødstrup ( Site 1901)
        • Contact:
          • Study Coordinator
          • Phone Number: 4591117070
    • Nordjylland
      • Aalborg, Nordjylland, Denmark, 9000
        • Recruiting
        • Aalborg Universitetshospital, Syd ( Site 1903)
        • Contact:
          • Study Coordinator
          • Phone Number: +4597666795
    • Syddanmark
      • Odense, Syddanmark, Denmark, 5000
        • Recruiting
        • Odense Universitetshospital ( Site 1902)
        • Contact:
          • Study Coordinator
          • Phone Number: 4565411590
  • Estonia
    • Harjumaa
      • Tallinn, Harjumaa, Estonia, 13419
        • Recruiting
        • North Estonia Medical Centre Foundation-Chemotherapy ( Site 2301)
        • Contact:
          • Study Coordinator
          • Phone Number: 3726171245
    • Tartumaa
      • Tartu, Tartumaa, Estonia, 50406
        • Recruiting
        • Tartu University Hospital ( Site 2302)
        • Contact:
          • Study Coordinator
          • Phone Number: 3727319568
  • France
      • Paris, France, 75571
        • Active, not recruiting
        • Hôpital Saint Antoine-Oncologie médicale ( Site 0508)
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13385
        • Completed
        • Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service d'Hepato-Gastro-Enterologie et
    • Cote-d Or
      • Dijon, Cote-d Or, France, 21079
        • Completed
        • Centre Georges François Leclerc ( Site 0506)
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Completed
        • CHU Rangueil-Digestive oncology department ( Site 0502)
    • Nord
      • Lille, Nord, France, 59037
        • Completed
        • Hopital Claude Huriez - CHU de Lille ( Site 0510)
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Active, not recruiting
        • Centre Hospitalier Universitaire de Poitiers ( Site 0511)
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0604)
        • Contact:
          • Study Coordinator
          • Phone Number: 4930450613132
      • Hamburg, Germany, 22763
        • Recruiting
        • Asklepios Altona-Oncology ( Site 0602)
        • Contact:
          • Study Coordinator
          • Phone Number: 0049 30 45050
    • Bayern
      • Muenchen, Bayern, Germany, 81737
        • Recruiting
        • Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie ( Site 0612)
        • Contact:
          • Study Coordinator
          • Phone Number: 498967942651
    • Hessen
      • Marburg, Hessen, Germany, 35043
        • Recruiting
        • Universitätsklinikum Marburg ( Site 0610)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 6421 5869034
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45136
        • Recruiting
        • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 0611)
        • Contact:
          • Study Coordinator
          • Phone Number: 4920117424524
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 0601)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 351 458 7683
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39120
        • Recruiting
        • Otto-von-Guericke-Universität Magdeburg-Klinik für Gastroenterologie, Hepatologie und Infektiologie
        • Contact:
          • Study Coordinator
          • Phone Number: +493916713100
  • Greece
      • Thessaloniki, Greece, 57001
        • Recruiting
        • European Interbalkan Medical Center-Oncology Department ( Site 2701)
        • Contact:
          • Study Coordinator
          • Phone Number: 306942608228
    • Attiki
      • Athens, Attiki, Greece, 115 28
        • Recruiting
        • Evgenidion Hospital ( Site 2702)
        • Contact:
          • Study Coordinator
          • Phone Number: +306944290909
      • Athens, Attiki, Greece, 115 28
        • Recruiting
        • Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 2704)
        • Contact:
          • Study Coordinator
          • Phone Number: 00306946462998
    • Irakleio
      • Heraklion, Irakleio, Greece, 715 00
        • Recruiting
        • University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 2703)
        • Contact:
          • Study Coordinator
          • Phone Number: 302810392750
  • Guatemala
      • Guatemala, Guatemala, 01016
        • Recruiting
        • MEDI-K CAYALA ( Site 2205)
        • Contact:
          • Study Coordinator
          • Phone Number: +50255505555
      • Guatemala, Guatemala, 01010
        • Recruiting
        • CELAN,S.A ( Site 2202)
        • Contact:
          • Study Coordinator
          • Phone Number: +50242142081
      • Guatemala, Guatemala, 01010
        • Recruiting
        • INTEGRA Cancer Institute-Oncology ( Site 2201)
        • Contact:
          • Study Coordinator
          • Phone Number: +50254530410
      • Quetzaltenango, Guatemala, 09002
        • Recruiting
        • Centro Medico Integral De Cancerología (CEMIC) ( Site 2203)
        • Contact:
          • Study Coordinator
          • Phone Number: +50259458053
      • Quetzaltenango, Guatemala, 09001
        • Recruiting
        • Centro Regional de Sub Especialidades Médicas SA ( Site 2204)
        • Contact:
          • Study Coordinator
          • Phone Number: +50259450559
  • Hungary
      • Budapest, Hungary, 1088
        • Recruiting
        • Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 2002)
        • Contact:
          • Study Coordinator
          • Phone Number: 36202051965
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 2008)
        • Contact:
          • Study Coordinator
          • Phone Number: 3652255840
    • Bacs-Kiskun
      • Kecskemét, Bacs-Kiskun, Hungary, 6000
        • Recruiting
        • Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2005)
        • Contact:
          • Study Coordinator
          • Phone Number: +3676516719
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Recruiting
        • Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2009)
        • Contact:
          • Study Coordinator
          • Phone Number: 36304400442
    • Jasz-Nagykun-Szolnok
      • Szolnok, Jasz-Nagykun-Szolnok, Hungary, 5000
        • Recruiting
        • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: 36209323256
    • Somogy
      • Kaposvár, Somogy, Hungary, 7400
        • Recruiting
        • Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 2010)
        • Contact:
          • Study Coordinator
          • Phone Number: +36303960374
  • Italy
      • Napoli, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale-Department of Abdominal Oncology ( Site 0803)
        • Contact:
          • Study Coordinator
          • Phone Number: +3908159031775
      • Padova, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto IRCCS ( Site 0804)
        • Contact:
          • Study Coordinator
          • Phone Number: 390498215910
    • Lombardia
      • Milan, Lombardia, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0802)
        • Contact:
          • Study Coordinator
          • Phone Number: +390223903835
  • Korea, Republic of
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital ( Site 1107)
        • Contact:
          • Study Coordinator
          • Phone Number: +8229206090
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital-Internal Medicine ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: +82220720795
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1104)
        • Contact:
          • Study Coordinator
          • Phone Number: +82 (2) 331 2471
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center-Department of Oncology ( Site 1105)
        • Contact:
          • Study Coordinator
          • Phone Number: +82 (2) 331 2471
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center-Division of Hematology/Oncology ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: 02-2148-7394
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital-Medical Oncology ( Site 1106)
        • Contact:
          • Study Coordinator
          • Phone Number: +82 (2) 331 2471
    • Taegu-Kwangyokshi
      • Daegu, Taegu-Kwangyokshi, Korea, Republic of, 41404
        • Recruiting
        • Kyungpook National University Chilgok Hospital-Hematology/oncology ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: 053-200-3017
  • Lithuania
      • Vilnius, Lithuania, 08460
        • Recruiting
        • VILNIUS UNIVERSITY HOSPITAL SANTAROS KLINIKOS ( Site 2403)
        • Contact:
          • Study Coordinator
          • Phone Number: +37068388052
    • Kauno Apskritis
      • Kaunas, Kauno Apskritis, Lithuania, 50161
        • Recruiting
        • Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: +37060105626
    • Vilniaus Miestas
      • Vilnius, Vilniaus Miestas, Lithuania, 08660
        • Recruiting
        • National Cancer Institute ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: +37064766126
  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1066CX
        • Recruiting
        • Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 2901)
        • Contact:
          • Study Coordinator
          • Phone Number: 31205122047
  • Poland
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 53-413
        • Recruiting
        • DOLNOSLASKIE CENTRUM ONKOLOGII PULMONOLOGII I HEMATOLOGII ( Site 0920)
        • Contact:
          • Study Coordinator
          • Phone Number: +48605363024
    • Lodzkie
      • Brzeziny, Lodzkie, Poland, 95-060
        • Recruiting
        • Powiatowe Centrum Zdrowia ( Site 0911)
        • Contact:
          • Study Coordinator
          • Phone Number: 48426895477
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 01-748
        • Recruiting
        • Luxmed Onkologia sp. z o. o. ( Site 0915)
        • Contact:
          • Study Coordinator
          • Phone Number: 48691666578
      • Warszawa, Mazowieckie, Poland, 02-034
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site
        • Contact:
          • Study Coordinator
          • Phone Number: 225709223
    • Podkarpackie
      • Rzeszow, Podkarpackie, Poland, 35-021
        • Recruiting
        • Mrukmed-Mrukmed ( Site 0901)
        • Contact:
          • Study Coordinator
          • Phone Number: 48178502470
    • Zachodniopomorskie
      • Koszalin, Zachodniopomorskie, Poland, 75-581
        • Recruiting
        • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0903)
        • Contact:
          • Study Coordinator
          • Phone Number: 943488930
  • Romania
    • Bucuresti
      • București, Bucuresti, Romania, 022548
        • Recruiting
        • Centrul medical Focus ( Site 2601)
        • Contact:
          • Study Coordinator
          • Phone Number: 40721298677
      • București, Bucuresti, Romania, 022328
        • Recruiting
        • Fundeni Clinical Institute-Medical Oncology ( Site 2603)
        • Contact:
          • Study Coordinator
          • Phone Number: 40722300252
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Recruiting
        • Cardiomed SRL Cluj-Napoca ( Site 2602)
        • Contact:
          • Study Coordinator
          • Phone Number: 0040724543672
    • Dolj
      • Craiova, Dolj, Romania, 200542
        • Recruiting
        • Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2604)
        • Contact:
          • Study Coordinator
          • Phone Number: 40727774974
  • Russian Federation
    • Leningradskaya Oblast
      • Saint Petersburg, Leningradskaya Oblast, Russian Federation, 198255
        • Completed
        • Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1001)
    • Moskva
      • Moscow, Moskva, Russian Federation, 115478
        • Completed
        • Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology-Clinical Pharmacology and Chemotherapy
      • Moscow, Moskva, Russian Federation, 119991
        • Completed
        • First Moscow State Medical University I.M. Sechenov-Interhospital Institution Health Management Cl
    • Rostovskaya Oblast
      • Rostov on Don, Rostovskaya Oblast, Russian Federation, 344037
        • Suspended
        • Rostov Cancer Research Institute ( Site 1014)
    • Sankt-Peterburg
      • Sankt- Peterburg, Sankt-Peterburg, Russian Federation, 197758
        • Completed
        • GBUZ SPb CRPCstmc(o) ( Site 1005)
    • Tatarstan, Respublika
      • Kazan, Tatarstan, Respublika, Russian Federation, 420029
        • Completed
        • Republican Clinical Oncology Dispensary-Chemotherapy #3 ( Site 1006)
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: +34934894350
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos-Oncology Department ( Site 1204)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913303000
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias-Medical Oncology ( Site 1203)
        • Contact:
          • Study Coordinator
          • Phone Number: +34985106100Ext36281
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla ( Site 1202)
        • Contact:
          • Study Coordinator
          • Phone Number: 34942202525
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28007
        • Recruiting
        • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1206)
        • Contact:
          • Study Coordinator
          • Phone Number: +34914269394
    • Malaga
      • Málaga, Malaga, Spain, 29010
        • Recruiting
        • H.R.U Malaga - Hospital General ( Site 1207)
        • Contact:
          • Study Coordinator
          • Phone Number: +34951308129
    • Navarra
      • Pamplona, Navarra, Spain, 31009
        • Recruiting
        • COMPLEJO HOSPITALARIO DE NAVARRA-oncologia médica ( Site 1210)
        • Contact:
          • Study Coordinator
          • Phone Number: 34 848422576
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46009
        • Recruiting
        • Fundación Instituto Valenciano de Oncología ( Site 1209)
        • Contact:
          • Study Coordinator
          • Phone Number: 34961245877
  • Turkey
      • Adana, Turkey, 01250
        • Recruiting
        • Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1303)
        • Contact:
          • Study Coordinator
          • Phone Number: +905325005269
      • Ankara, Turkey, 06230
        • Recruiting
        • Hacettepe Universitesi-oncology hospital ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: +903123051080
      • Ankara, Turkey, 06800
        • Recruiting
        • Ankara City Hospital-Medical Oncology ( Site 1306)
        • Contact:
          • Study Coordinator
          • Phone Number: +905555306271
      • Istanbul, Turkey, 34722
        • Recruiting
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1305)
        • Contact:
          • Study Coordinator
          • Phone Number: +90216 606 52 00
      • Istanbul, Turkey, 34668
        • Recruiting
        • Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: +902124143000
  • United Kingdom
      • Cardiff, United Kingdom, CF14 2TL
        • Recruiting
        • Velindre Cancer Centre-Research and Development ( Site 1415)
        • Contact:
          • Study Coordinator
          • Phone Number: 02920615888
      • Coventry, United Kingdom, CV2 2DX
        • Recruiting
        • University Hospital Coventry & Warwickshire ( Site 1406)
        • Contact:
          • Study Coordinator
          • Phone Number: 02476967151
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G12 0YN
        • Recruiting
        • Beatson West of Scotland Cancer Centre-Clinical Trials Unit ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: 01413017121
    • London, City Of
      • London-Camden, London, City Of, United Kingdom, NW1 2PG
        • Active, not recruiting
        • UCLH-Cancer Clinical Trials Unit ( Site 1402)
  • United States
    • Florida
      • Orange City, Florida, United States, 32763
        • Completed
        • Mid Florida Cancer Center ( Site 1519)
    • Georgia
      • Athens, Georgia, United States, 30607
        • Completed
        • University Cancer & Blood Center, LLC ( Site 1521)
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Completed
        • University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P
    • New York
      • New York, New York, United States, 10029
        • Completed
        • Icahn School of Medicine at Mount Sinai ( Site 1528)
      • Nyack, New York, United States, 10960
        • Recruiting
        • Hematology Oncology Associates of Rockland ( Site 1525)
        • Contact:
          • Study Coordinator
          • Phone Number: 845-480-7440
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Completed
        • UPMC Hillman Cancer Center ( Site 1516)
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • The West Clinic, PLLC dba West Cancer Center ( Site 1576)
        • Contact:
          • Study Coordinator
          • Phone Number: 901-683-0055
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 1509)
        • Contact:
          • Study Coordinator
          • Phone Number: 800-811-8480
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center ( Site 1551)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-645-4673
      • Temple, Texas, United States, 76508
        • Completed
        • Baylor Scott & White Medical Center - Temple-Division of Hematology/Oncology ( Site 1549)
    • Washington
      • Tacoma, Washington, United States, 98405
        • Completed
        • Northwest Medical Specialties, PLLC ( Site 1546)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has a histologically confirmed diagnosis of Stage IV CRC adenocarcinoma (as defined by American Joint Committee on Cancer [AJCC] version 8)
  • Has locally confirmed dMMR/MSI-H
  • Has a life expectancy of at least 3 months
  • Female participants are eligible to participate if not pregnant or breastfeeding, and not a woman of childbearing potential (WOCBP), or if a WOCBP then uses a contraceptive method that is highly effective or is abstinent on a long-term and persistent basis, during the intervention period and for at least 120 days after the last dose of study intervention
  • Has measurable disease per RECIST 1.1 as assessed by the site and verified by BICR
  • Submit an archival (within 5 years of Screening) or newly obtained tumor tissue sample that has not been previously irradiated; formalin-fixed, paraffin embedded (FFPE) blocks are preferred to slides.
  • Has adequate organ function

Cohort A:

- Has been previously treated for their Stage IV dMMR/MSI-H CRC and radiographically progressed on or after or could not tolerate standard treatment, which must include all of the following agents if approved and locally available in the country where the participant is randomized:

  • Fluoropyrimidine, irinotecan and oxaliplatin (capecitabine is acceptable as equivalent to fluorouracil in prior therapy)
  • With or without an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (e.g., bevacizumab)
  • At least one of the anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (cetuximab or panitumumab) for rat sarcoma viral oncogene homolog (RAS) wild-type participants with left-sided tumors. Prior EGFR therapy is optional for patients with right sided RAS Wild-type (WT) tumors.

Cohort B:

- Has untreated Stage IV dMMR/MSI-H CRC with no prior chemotherapy or immunotherapy for this disease

Exclusion Criteria:

  • Has received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor
  • Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
  • Has not recovered adequately from a surgery procedure, and/or has any complications from a prior surgery before starting study intervention
  • Has received prior radiotherapy within 2 weeks of start of study intervention
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
  • Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab, quavonlimab, favezelimab, vibostolimab, MK-4830, and/or any of their excipients
  • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
  • Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
  • Has a history of acute or chronic pancreatitis
  • Has neuromuscular disorders associated with an elevated creatine kinase
  • Has urine protein ≥1 gram/24 hours
  • Has an active infection requiring systemic therapy (e.g., tuberculosis, known viral or bacterial infections, etc.)
  • Has a known history of Human Immunodeficiency Virus (HIV) infection
  • Concurrent active Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] positive and/or detectable Hepatitis B Virus [HBV] deoxyribonucleic acid [DNA]) and Hepatitis C virus (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid [RNA] infection
  • Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study intervention administration, or New York Heart Association Class III or IV congestive heart failure. Medically controlled arrhythmia stable on medication is permitted.
  • Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before randomization/allocation
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
  • Has had an allogenic tissue/solid organ transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pembrolizumab
Participants receive pembrolizumab 400 mg intravenously (IV) every 6 weeks (Q6W) for up to approximately 2 years.
Biological: Pembrolizumab
400 mg or 200 mg pembrolizumab administered via IV infusion.
Other Names:
  • MK-3475
  • Keytruda®
Experimental: Pembrolizumab/Quavonlimab
Participants receive co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.
Biological: Pembrolizumab/Quavonlimab
Co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) fixed-dose combination (FDC) administered via IV infusion.
Other Names:
  • MK-1308A
Experimental: Pembrolizumab/Favezelimab
Participants receive co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.
Biological: Pembrolizumab/Favezelimab
Co-formulated pembrolizumab/favezelimab (200 mg/800 mg) FDC administered via IV infusion
Other Names:
  • MK-4280A
Experimental: Pembrolizumab/Vibostolimab
Participants receive co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.
Biological: Pembrolizumab/Vibostolimab
Co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) FDC administered via IV infusion
Other Names:
  • MK-7684A
Experimental: Pembrolizumab Plus MK-4830
Participants receive pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years.
Biological: Pembrolizumab
400 mg or 200 mg pembrolizumab administered via IV infusion.
Other Names:
  • MK-3475
  • Keytruda®
Biological: MK-4830
800 mg MK-4830 administered via IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Up to approximately 50 months
ORR is 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 will be presented.
Up to approximately 50 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR) per RECIST 1.1 as assessed by BICR
Time Frame: Up to approximately 50 months
DOR is defined as the time from the first documented evidence of a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until Progressive Disease (PD) or death due to any cause, whichever occurs first, in participants demonstrating a CR or PR. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Up to approximately 50 months
Progression-Free Survival (PFS) per RECIST 1.1 as assessed by BICR
Time Frame: Up to approximately 50 months
PFS is defined as the time from randomization (or first dose) to the first documented PD per RECIST 1.1 or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Up to approximately 50 months
PFS per RECIST 1.1 as assessed by Investigator
Time Frame: Up to approximately 50 months
PFS is defined as the time from randomization (or first dose) to the first documented PD per RECIST 1.1 or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by investigator will be presented.
Up to approximately 50 months
ORR per RECIST 1.1 as assessed by Investigator
Time Frame: Up to approximately 50 months
ORR is defined as the percentage of participants who have a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed by investigator will be presented.
Up to approximately 50 months
DOR per RECIST 1.1 as assessed by Investigator
Time Frame: Up to approximately 50 months
DOR is defined as the time from the first documented evidence of a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until PD or death due to any cause, whichever occurs first, in participants demonstrating a CR or PR. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigator will be presented.
Up to approximately 50 months
Overall Survival (OS)
Time Frame: Up to approximately 50 months
OS is defined as the time from randomization (or first dose) to death due to any cause. OS will be presented.
Up to approximately 50 months
Number of Participants Who Experienced an Adverse Event (AE)
Time Frame: Up to approximately 50 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study intervention. The number of participants with an AE will be presented.
Up to approximately 50 months
Number of Participants Discontinuing Study Treatment Due to an AE
Time Frame: Up to approximately 50 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study intervention. The number of participants that discontinue study treatment due to an AE will be presented.
Up to approximately 50 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2021

Primary Completion (Estimated)

October 20, 2025

Study Completion (Estimated)

November 18, 2025

Study Registration Dates

First Submitted

May 18, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1308A-008
  • MK-1308A-008 (Other Identifier: Merck)
  • 2020-005114-18 (EudraCT Number)
  • 2022-502100-70 (Other Identifier: EU CT)
  • KEYSTEP-008 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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