Colorectal Cancer Clinical Trial
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)
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.
| Status | Recruiting |
| Enrollment | 320 |
| Est. completion date | November 18, 2025 |
| Est. primary completion date | October 20, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0104) | Brussels | Bruxelles-Capitale, Region De |
| Belgium | UZ Brussel ( Site 0105) | Brussels | Bruxelles-Capitale, Region De |
| Belgium | UZ Leuven ( Site 0101) | Leuven | Vlaams-Brabant |
| Belgium | AZ Delta vzw ( Site 0106) | Roeselare | West-Vlaanderen |
| Belgium | Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0102) | Yvoir | Namur |
| Canada | The Moncton Hospital-Oncology ( Site 0307) | Moncton | New Brunswick |
| Canada | McGill University Health Centre-CIM - Oncology ( Site 0306) | Montréal | Quebec |
| Canada | Sunnybrook Research Institute - Odette Cancer Centre ( Site 0316) | Toronto | Ontario |
| Colombia | Clinica de la Costa S.A.S. ( Site 1608) | Barranquilla | Atlantico |
| Colombia | Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 1611) | Bogota | Distrito Capital De Bogota |
| Colombia | Mediservis del Tolima IPS S.A.S ( Site 1609) | Ibague | Tolima |
| Colombia | Fundación Colombiana de Cancerología Clínica Vida ( Site 1606) | Medellin | Antioquia |
| Colombia | Instituto de Cancerología ( Site 1610) | Medellin | Antioquia |
| Colombia | Oncomédica S.A.S ( Site 1602) | Montería | Cordoba |
| Colombia | Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1601) | Valledupar | Cesar |
| Costa Rica | CIMCA-Hemato-Oncology ( Site 2101) | San José | San Jose |
| Costa Rica | Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 2102) | Santa Ana | San Jose |
| Denmark | Aalborg Universitetshospital, Syd ( Site 1903) | Aalborg | Nordjylland |
| Denmark | Rigshospitalet ( Site 1904) | Copenhagen | Hovedstaden |
| Denmark | Regionshospitalet Gødstrup ( Site 1901) | Herning | Midtjylland |
| Denmark | Odense Universitetshospital ( Site 1902) | Odense | Syddanmark |
| Estonia | North Estonia Medical Centre Foundation-Chemotherapy ( Site 2301) | Tallinn | Harjumaa |
| Estonia | Tartu University Hospital ( Site 2302) | Tartu | Tartumaa |
| France | Centre Georges François Leclerc ( Site 0506) | Dijon | Cote-d Or |
| France | Hopital Claude Huriez - CHU de Lille ( Site 0510) | Lille | Nord |
| France | Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service d'Hepato-Gastro-Enterologie et | Marseille | Bouches-du-Rhone |
| France | Hôpital Saint Antoine-Oncologie médicale ( Site 0508) | Paris | |
| France | Centre Hospitalier Universitaire de Poitiers ( Site 0511) | Poitiers | Vienne |
| France | CHU Rangueil-Digestive oncology department ( Site 0502) | Toulouse | Haute-Garonne |
| Germany | Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0604) | Berlin | |
| Germany | Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 0601) | Dresden | Sachsen |
| Germany | Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 0611) | Essen | Nordrhein-Westfalen |
| Germany | Asklepios Altona-Oncology ( Site 0602) | Hamburg | |
| Germany | Otto-von-Guericke-Universität Magdeburg-Klinik für Gastroenterologie, Hepatologie und Infektiologie | Magdeburg | Sachsen-Anhalt |
| Germany | Universitätsklinikum Marburg ( Site 0610) | Marburg | Hessen |
| Germany | Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie ( Site 0612) | Muenchen | Bayern |
| Greece | Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 2704) | Athens | Attiki |
| Greece | Evgenidion Hospital ( Site 2702) | Athens | Attiki |
| Greece | University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 2703) | Heraklion | Irakleio |
| Greece | European Interbalkan Medical Center-Oncology Department ( Site 2701) | Thessaloniki | |
| Guatemala | CELAN,S.A ( Site 2202) | Guatemala | |
| Guatemala | INTEGRA Cancer Institute-Oncology ( Site 2201) | Guatemala | |
| Guatemala | MEDI-K CAYALA ( Site 2205) | Guatemala | |
| Guatemala | Centro Medico Integral De Cancerología (CEMIC) ( Site 2203) | Quetzaltenango | |
| Guatemala | Centro Regional de Sub Especialidades Médicas SA ( Site 2204) | Quetzaltenango | |
| Hungary | Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 2002) | Budapest | |
| Hungary | Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 2008) | Debrecen | |
| Hungary | Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 2010) | Kaposvár | Somogy |
| Hungary | Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2005) | Kecskemét | Bacs-Kiskun |
| Hungary | Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2009) | Pécs | Baranya |
| Hungary | Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2001) | Szolnok | Jasz-Nagykun-Szolnok |
| Italy | Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0802) | Milan | Lombardia |
| Italy | Istituto Nazionale Tumori IRCCS Fondazione Pascale-Department of Abdominal Oncology ( Site 0803) | Napoli | |
| Italy | Istituto Oncologico Veneto IRCCS ( Site 0804) | Padova | |
| Korea, Republic of | Kyungpook National University Chilgok Hospital-Hematology/oncology ( Site 1103) | Daegu | Taegu-Kwangyokshi |
| Korea, Republic of | Asan Medical Center-Department of Oncology ( Site 1105) | Seoul | |
| Korea, Republic of | Korea University Anam Hospital ( Site 1107) | Seoul | |
| Korea, Republic of | Samsung Medical Center-Division of Hematology/Oncology ( Site 1102) | Seoul | |
| Korea, Republic of | Seoul National University Hospital-Internal Medicine ( Site 1101) | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1104) | Seoul | |
| Korea, Republic of | The Catholic Univ. of Korea Seoul St. Mary's Hospital-Medical Oncology ( Site 1106) | Seoul | |
| Lithuania | Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 2402) | Kaunas | Kauno Apskritis |
| Lithuania | National Cancer Institute ( Site 2401) | Vilnius | Vilniaus Miestas |
| Lithuania | VILNIUS UNIVERSITY HOSPITAL SANTAROS KLINIKOS ( Site 2403) | Vilnius | |
| Netherlands | Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 2901) | Amsterdam | Noord-Holland |
| Poland | Powiatowe Centrum Zdrowia ( Site 0911) | Brzeziny | Lodzkie |
| Poland | Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0903) | Koszalin | Zachodniopomorskie |
| Poland | Mrukmed-Mrukmed ( Site 0901) | Rzeszow | Podkarpackie |
| Poland | Luxmed Onkologia sp. z o. o. ( Site 0915) | Warszawa | Mazowieckie |
| Poland | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site | Warszawa | Mazowieckie |
| Poland | DOLNOSLASKIE CENTRUM ONKOLOGII PULMONOLOGII I HEMATOLOGII ( Site 0920) | Wroclaw | Dolnoslaskie |
| Romania | Centrul medical Focus ( Site 2601) | Bucure?ti | Bucuresti |
| Romania | Fundeni Clinical Institute-Medical Oncology ( Site 2603) | Bucure?ti | Bucuresti |
| Romania | Cardiomed SRL Cluj-Napoca ( Site 2602) | Cluj-Napoca | Cluj |
| Romania | Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2604) | Craiova | Dolj |
| Russian Federation | Republican Clinical Oncology Dispensary-Chemotherapy #3 ( Site 1006) | Kazan | Tatarstan, Respublika |
| Russian Federation | Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology-Clinical Pharmacology and Chemotherapy | Moscow | Moskva |
| Russian Federation | First Moscow State Medical University I.M. Sechenov-Interhospital Institution Health Management Cl | Moscow | Moskva |
| Russian Federation | Rostov Cancer Research Institute ( Site 1014) | Rostov on Don | Rostovskaya Oblast |
| Russian Federation | Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1001) | Saint Petersburg | Leningradskaya Oblast |
| Russian Federation | GBUZ SPb CRPCstmc(o) ( Site 1005) | Sankt- Peterburg | Sankt-Peterburg |
| Spain | Hospital Universitari Vall d'Hebron ( Site 1201) | Barcelona | Cataluna |
| Spain | Hospital Clinico San Carlos-Oncology Department ( Site 1204) | Madrid | |
| Spain | HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1206) | Madrid | Madrid, Comunidad De |
| Spain | H.R.U Malaga - Hospital General ( Site 1207) | Málaga | Malaga |
| Spain | Hospital Universitario Central de Asturias-Medical Oncology ( Site 1203) | Oviedo | Asturias |
| Spain | COMPLEJO HOSPITALARIO DE NAVARRA-oncologia médica ( Site 1210) | Pamplona | Navarra |
| Spain | Hospital Universitario Marqués de Valdecilla ( Site 1202) | Santander | Cantabria |
| Spain | Fundación Instituto Valenciano de Oncología ( Site 1209) | Valencia | Valenciana, Comunitat |
| Turkey | Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1303) | Adana | |
| Turkey | Ankara City Hospital-Medical Oncology ( Site 1306) | Ankara | |
| Turkey | Hacettepe Universitesi-oncology hospital ( Site 1301) | Ankara | |
| Turkey | Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1302) | Istanbul | |
| Turkey | TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1305) | Istanbul | |
| United Kingdom | Velindre Cancer Centre-Research and Development ( Site 1415) | Cardiff | |
| United Kingdom | University Hospital Coventry & Warwickshire ( Site 1406) | Coventry | |
| United Kingdom | 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 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 | UT Southwestern Medical Center ( Site 1551) | Dallas | Texas |
| 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 | 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 | Mid Florida Cancer Center ( Site 1519) | Orange City | Florida |
| United States | UPMC Hillman Cancer Center ( Site 1516) | Pittsburgh | Pennsylvania |
| United States | Northwest Medical Specialties, PLLC ( Site 1546) | Tacoma | Washington |
| United States | Baylor Scott & White Medical Center - Temple-Division of Hematology/Oncology ( Site 1549) | Temple | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Belgium, Canada, Colombia, Costa Rica, Denmark, Estonia, France, Germany, Greece, Guatemala, Hungary, Italy, Korea, Republic of, Lithuania, Netherlands, Poland, Romania, Russian Federation, Spain, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | 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 | Duration of Response (DOR) per RECIST 1.1 as assessed by BICR | 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 | |
| Secondary | Progression-Free Survival (PFS) per RECIST 1.1 as assessed by BICR | 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 | |
| Secondary | PFS per RECIST 1.1 as assessed by Investigator | 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 | |
| Secondary | ORR per RECIST 1.1 as assessed by Investigator | 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 | |
| Secondary | DOR per RECIST 1.1 as assessed by Investigator | 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 | |
| Secondary | Overall Survival (OS) | 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 | |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | 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 | |
| Secondary | Number of Participants Discontinuing Study Treatment Due to an AE | 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 |
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