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)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

302

Participants

Timeline

Start Date

June 25, 2021

Primary Completion Date

May 21, 2025

Study Completion Date

April 30, 2026

Conditions
Colorectal Cancer
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

Trial Locations (109)

1000

CIMCA-Hemato-Oncology ( Site 2101), San José

1088

Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 2002), Budapest

1090

UZ Brussel ( Site 0105), Brussels

1200

Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0104), Brussels

2100

Rigshospitalet ( Site 1904), Copenhagen

3000

UZ Leuven ( Site 0101), Leuven

4032

Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 2008), Debrecen

5000

Odense Universitetshospital ( Site 1902), Odense

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2001), Szolnok

5530

Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0102), Yvoir

6000

Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2005), Kecskemét

7400

Regionshospitalet Gødstrup ( Site 1901), Herning

Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 2010), Kaposvár

7624

Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2009), Pécs

8800

AZ Delta vzw ( Site 0106), Roeselare

9000

Aalborg Universitetshospital, Syd ( Site 1903), Aalborg

10029

Icahn School of Medicine at Mount Sinai ( Site 1528), New York

10117

Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0604), Berlin

10903

Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 2102), Santa Ana

10960

Hematology Oncology Associates of Rockland ( Site 1525), Nyack

13385

Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service d'Hepato-Gastro-Enterologie et, Marseille

13419

North Estonia Medical Centre Foundation-Chemotherapy ( Site 2301), Tallinn

15232

UPMC Hillman Cancer Center ( Site 1516), Pittsburgh

20133

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0802), Milan

21079

Centre Georges François Leclerc ( Site 0506), Dijon

22763

Asklepios Altona-Oncology ( Site 0602), Hamburg

28007

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1206), Madrid

28040

Hospital Clinico San Carlos-Oncology Department ( Site 1204), Madrid

29010

H.R.U Malaga - Hospital General ( Site 1207), Málaga

30607

University Cancer & Blood Center, LLC ( Site 1521), Athens

31009

COMPLEJO HOSPITALARIO DE NAVARRA-oncologia médica ( Site 1210), Pamplona

31059

CHU Rangueil-Digestive oncology department ( Site 0502), Toulouse

32763

Mid Florida Cancer Center ( Site 1519), Orange City

33011

Hospital Universitario Central de Asturias-Medical Oncology ( Site 1203), Oviedo

34668

Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1302), Istanbul

34722

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1305), Istanbul

35043

Universitätsklinikum Marburg ( Site 0610), Marburg

35128

Istituto Oncologico Veneto IRCCS ( Site 0804), Padua

37232

Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 1509), Nashville

38138

The West Clinic, PLLC dba West Cancer Center ( Site 1576), Germantown

39008

Hospital Universitario Marqués de Valdecilla ( Site 1202), Santander

39120

Otto-von-Guericke-Universität Magdeburg-Klinik für Gastroenterologie, Hepatologie und Infektiologie, Magdeburg

41404

Kyungpook National University Chilgok Hospital-Hematology/oncology ( Site 1103), Daegu

45136

Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 0611), Essen

46009

Fundación Instituto Valenciano de Oncología ( Site 1209), Valencia

50161

Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 2402), Kaunas

50406

Tartu University Hospital ( Site 2302), Tartu

57001

European Interbalkan Medical Center-Oncology Department ( Site 2701), Thessaloniki

59037

Hopital Claude Huriez - CHU de Lille ( Site 0510), Lille

60637

University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P, Chicago

75390

UT Southwestern Medical Center ( Site 1551), Dallas

75571

Hôpital Saint Antoine-Oncologie médicale ( Site 0508), Paris

76508

Baylor Scott & White Medical Center - Temple-Division of Hematology/Oncology ( Site 1549), Temple

80131

Istituto Nazionale Tumori IRCCS Fondazione Pascale-Department of Abdominal Oncology ( Site 0803), Napoli

81737

Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie ( Site 0612), Munich

86021

Centre Hospitalier Universitaire de Poitiers ( Site 0511), Poitiers

98405

Northwest Medical Specialties, PLLC ( Site 1546), Tacoma

111321

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 1611), Bogotá

115478

Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology-Clinical Pharmacology and Chemotherapy, Moscow

119991

First Moscow State Medical University I.M. Sechenov-Interhospital Institution Health Management Cl, Moscow

197758

GBUZ SPb CRPCstmc(o) ( Site 1005), Saint Petersburg

198255

Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1001), Saint Petersburg

200001

Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1601), Valledupar

200542

"Centrul de Oncologie Sfântul Nectarie-Medical Oncology ( Site 2604)", Craiova

230002

Oncomédica S.A.S ( Site 1602), Montería

344037

Rostov Cancer Research Institute ( Site 1014), Rostov-on-Don

400015

Cardiomed SRL Cluj-Napoca ( Site 2602), Cluj-Napoca

420029

Republican Clinical Oncology Dispensary-Chemotherapy #3 ( Site 1006), Kazan'

730006

Mediservis del Tolima IPS S.A.S ( Site 1609), Ibagué

E1C 6Z8

The Moncton Hospital-Oncology ( Site 0307), Moncton

M4N 3M5

Sunnybrook Research Institute - Odette Cancer Centre ( Site 0316), Toronto

H4A 3J1

McGill University Health Centre-CIM - Oncology ( Site 0306), Montreal

050025

Instituto de Cancerología ( Site 1610), Medellín

050030

Fundación Colombiana de Cancerología Clínica Vida ( Site 1606), Medellín

080020

Clinica de la Costa S.A.S. ( Site 1608), Barranquilla

01307

Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 0601), Dresden

115 28

Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 2704), Athens

Evgenidion Hospital ( Site 2702), Athens

715 00

University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 2703), Heraklion

01010

CELAN,S.A ( Site 2202), Guatemala City

INTEGRA Cancer Institute-Oncology ( Site 2201), Guatemala City

01016

MEDI-K CAYALA ( Site 2205), Guatemala City

09001

Centro Regional de Sub Especialidades Médicas SA ( Site 2204), Quetzaltenango

09002

Centro Medico Integral De Cancerología (CEMIC) ( Site 2203), Quetzaltenango

08660

National Cancer Institute ( Site 2401), Vilnius

08460

VILNIUS UNIVERSITY HOSPITAL SANTAROS KLINIKOS ( Site 2403), Vilnius

1066CX

Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 2901), Amsterdam

53-413

DOLNOSLASKIE CENTRUM ONKOLOGII PULMONOLOGII I HEMATOLOGII ( Site 0920), Wroclaw

01-748

Luxmed Onkologia sp. z o. o. ( Site 0915), Warsaw

02-034

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site, Warsaw

35-021

Mrukmed-Mrukmed ( Site 0901), Rzeszów

75-581

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0903), Koszalin

95-060

Powiatowe Centrum Zdrowia ( Site 0911), Brzeziny

013812

Spitalul de Oncologie Monza Oncologie Medicala ( Site 2601), Bucharest

022328

Fundeni Clinical Institute-Medical Oncology ( Site 2603), Bucharest

02841

Korea University Anam Hospital ( Site 1107), Seoul

03080

Seoul National University Hospital-Internal Medicine ( Site 1101), Seoul

03722

Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1104), Seoul

05505

Asan Medical Center-Department of Oncology ( Site 1105), Seoul

06351

Samsung Medical Center-Division of Hematology/Oncology ( Site 1102), Seoul

06591

The Catholic Univ. of Korea Seoul St. Mary's Hospital-Medical Oncology ( Site 1106), Seoul

08035

Hospital Universitari Vall d'Hebron ( Site 1201), Barcelona

01250

Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1303), Adana

06230

Hacettepe Universitesi-oncology hospital ( Site 1301), Ankara

06800

Ankara City Hospital-Medical Oncology ( Site 1306), Ankara

G12 0YN

Beatson West of Scotland Cancer Centre-Clinical Trials Unit ( Site 1401), Glasgow

NW1 2PG

UCLH-Cancer Clinical Trials Unit ( Site 1402), London-Camden

CF14 2TL

Velindre Cancer Centre-Research and Development ( Site 1415), Cardiff

CV2 2DX

University Hospital Coventry & Warwickshire ( Site 1406), Coventry

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY