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New immunotherapy cocktail targets Hard-to-Treat bowel cancer

NCT ID NCT04895722

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This Phase 2 trial tests a combination of pembrolizumab (Keytruda) and quavonlimab against other drug combos in 302 people with stage IV colorectal cancer that has a specific genetic feature (MSI-H or dMMR). The goal is to see if the new combo shrinks tumors better and for longer. Participants receive the drugs by IV infusion, and the study compares response rates and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pembrolizumab (Keytruda) combined with quavonlimab, favezelimab, or vibostolimab
What this could lead to
If successful, this could offer a new combination immunotherapy option for people with a specific type of advanced colorectal cancer that has not responded to other treatments.
What could go wrong
This is a Phase 2 trial, so results are still early. The combination may not work better than existing treatments, and side effects from immunotherapy can be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

302 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 colorectal cancer colorectal neoplasm Lynch syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer

Contacts and locations

Locations

  • AZ Delta vzw ( Site 0106)

    Roeselare, West-Vlaanderen, 8800, Belgium

  • Aalborg Universitetshospital, Syd ( Site 1903)

    Aalborg, North Denmark, 9000, Denmark

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

    Athens, Attica, 115 28, Greece

  • Ankara City Hospital-Medical Oncology ( Site 1306)

    Ankara, 06800, Turkey (Türkiye)

  • Asan Medical Center-Department of Oncology ( Site 1105)

    Seoul, 05505, South Korea

  • Asklepios Altona-Oncology ( Site 0602)

    Hamburg, 22763, Germany

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

    Marseille, Bouches-du-Rhone, 13385, France

  • Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2005)

    Kecskemét, Bács-Kiskun county, 6000, Hungary

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

    Adana, 01250, Turkey (Türkiye)

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

    Temple, Texas, 76508, United States

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

    Glasgow, Glasgow City, G12 0YN, United Kingdom

  • CELAN,S.A ( Site 2202)

    Guatemala City, 01010, Guatemala

  • CHU Rangueil-Digestive oncology department ( Site 0502)

    Toulouse, Haute-Garonne, 31059, France

  • CIMCA-Hemato-Oncology ( Site 2101)

    San José, Provincia de San José, 1000, Costa Rica

  • COMPLEJO HOSPITALARIO DE NAVARRA-oncologia médica ( Site 1210)

    Pamplona, Navarre, 31009, Spain

  • Cardiomed SRL Cluj-Napoca ( Site 2602)

    Cluj-Napoca, Cluj, 400015, Romania

  • Centre Georges François Leclerc ( Site 0506)

    Dijon, Cote-d Or, 21079, France

  • Centre Hospitalier Universitaire de Poitiers ( Site 0511)

    Poitiers, Vienne, 86021, France

  • Centro Medico Integral De Cancerología (CEMIC) ( Site 2203)

    Quetzaltenango, 09002, Guatemala

  • Centro Regional de Sub Especialidades Médicas SA ( Site 2204)

    Quetzaltenango, 09001, Guatemala

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

    Craiova, Dolj, 200542, Romania

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0604)

    Berlin, 10117, Germany

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

    Bogotá, Bogota D.C., 111321, Colombia

  • Clinica de la Costa S.A.S. ( Site 1608)

    Barranquilla, Atlántico, 080020, Colombia

  • Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0104)

    Brussels, Bruxelles-Capitale, Region de, 1200, Belgium

  • DOLNOSLASKIE CENTRUM ONKOLOGII PULMONOLOGII I HEMATOLOGII ( Site 0920)

    Wroclaw, Lower Silesian Voivodeship, 53-413, Poland

  • Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 2008)

    Debrecen, 4032, Hungary

  • European Interbalkan Medical Center-Oncology Department ( Site 2701)

    Thessaloniki, 57001, Greece

  • Evgenidion Hospital ( Site 2702)

    Athens, Attica, 115 28, Greece

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

    Moscow, Moscow, 115478, Russia

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

    Moscow, Moscow, 119991, Russia

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

    Milan, Lombardy, 20133, Italy

  • Fundación Colombiana de Cancerología Clínica Vida ( Site 1606)

    Medellín, Antioquia, 050030, Colombia

  • Fundación Instituto Valenciano de Oncología ( Site 1209)

    Valencia, Valenciana, Comunitat, 46009, Spain

  • Fundeni Clinical Institute-Medical Oncology ( Site 2603)

    Bucharest, Bucharest, 022328, Romania

  • GBUZ SPb CRPCstmc(o) ( Site 1005)

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

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

    Málaga, Malaga, 29010, Spain

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1206)

    Madrid, Madrid, Comunidad de, 28007, Spain

  • Hacettepe Universitesi-oncology hospital ( Site 1301)

    Ankara, 06230, Turkey (Türkiye)

  • Hematology Oncology Associates of Rockland ( Site 1525)

    Nyack, New York, 10960, United States

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

    Lille, Nord, 59037, France

  • Hospital Clinico San Carlos-Oncology Department ( Site 1204)

    Madrid, 28040, Spain

  • Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 2102)

    Santa Ana, Provincia de San José, 10903, Costa Rica

  • Hospital Universitari Vall d'Hebron ( Site 1201)

    Barcelona, Catalonia, 08035, Spain

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

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario Marqués de Valdecilla ( Site 1202)

    Santander, Cantabria, 39008, Spain

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

    Kaunas, Kaunas County, 50161, Lithuania

  • Hôpital Saint Antoine-Oncologie médicale ( Site 0508)

    Paris, 75571, France

  • INTEGRA Cancer Institute-Oncology ( Site 2201)

    Guatemala City, 01010, Guatemala

  • Icahn School of Medicine at Mount Sinai ( Site 1528)

    New York, New York, 10029, United States

  • Instituto de Cancerología ( Site 1610)

    Medellín, Antioquia, 050025, Colombia

  • Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1302)

    Istanbul, 34668, Turkey (Türkiye)

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

    Naples, 80131, Italy

  • Istituto Oncologico Veneto IRCCS ( Site 0804)

    Padova, 35128, Italy

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

    Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

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

    Essen, North Rhine-Westphalia, 45136, Germany

  • Korea University Anam Hospital ( Site 1107)

    Seoul, 02841, South Korea

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

    Daegu, Taegu-Kwangyokshi, 41404, South Korea

  • Luxmed Onkologia sp. z o. o. ( Site 0915)

    Warsaw, Masovian Voivodeship, 01-748, Poland

  • MEDI-K CAYALA ( Site 2205)

    Guatemala City, 01016, Guatemala

  • McGill University Health Centre-CIM - Oncology ( Site 0306)

    Montreal, Quebec, H4A 3J1, Canada

  • Mediservis del Tolima IPS S.A.S ( Site 1609)

    Ibague, Tolima Department, 730006, Colombia

  • Mid Florida Cancer Center ( Site 1519)

    Orange City, Florida, 32763, United States

  • Mrukmed-Mrukmed ( Site 0901)

    Rzeszów, Podkarpackie Voivodeship, 35-021, Poland

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

    Munich, Bavaria, 81737, Germany

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

    Warsaw, Masovian Voivodeship, 02-034, Poland

  • National Cancer Institute ( Site 2401)

    Vilnius, Vilniaus Miestas, 08660, Lithuania

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

    Amsterdam, North Holland, 1066CX, Netherlands

  • North Estonia Medical Centre Foundation-Chemotherapy ( Site 2301)

    Tallinn, Harju, 13419, Estonia

  • Northwest Medical Specialties, PLLC ( Site 1546)

    Tacoma, Washington, 98405, United States

  • Odense Universitetshospital ( Site 1902)

    Odense, Region Syddanmark, 5000, Denmark

  • Oncomédica S.A.S ( Site 1602)

    Montería, Departamento de Córdoba, 230002, Colombia

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

    Magdeburg, Saxony-Anhalt, 39120, Germany

  • Powiatowe Centrum Zdrowia ( Site 0911)

    Brzeziny, Łódź Voivodeship, 95-060, Poland

  • Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2009)

    Pécs, Baranya, 7624, Hungary

  • Regionshospitalet Gødstrup ( Site 1901)

    Herning, Central Jutland, 7400, Denmark

  • Republican Clinical Oncology Dispensary-Chemotherapy #3 ( Site 1006)

    Kazan', Tatarstan, Respublika, 420029, Russia

  • Rigshospitalet ( Site 1904)

    Copenhagen, Capital Region, 2100, Denmark

  • Rostov Cancer Research Institute ( Site 1014)

    Rostov-on-Don, Rostov Oblast, 344037, Russia

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

    Saint Petersburg, Leningradskaya Oblast', 198255, Russia

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

    Seoul, 06351, South Korea

  • Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 2002)

    Budapest, 1088, Hungary

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

    Seoul, 03080, South Korea

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

    Seoul, 03722, South Korea

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

    Valledupar, Cesar Department, 200001, Colombia

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

    Kaposvár, Somogy County, 7400, Hungary

  • Spitalul de Oncologie Monza Oncologie Medicala ( Site 2601)

    Bucharest, Bucharest, 013812, Romania

  • Sunnybrook Research Institute - Odette Cancer Centre ( Site 0316)

    Toronto, Ontario, M4N 3M5, Canada

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

    Koszalin, West Pomeranian Voivodeship, 75-581, Poland

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

    Istanbul, 34722, Turkey (Türkiye)

  • Tartu University Hospital ( Site 2302)

    Tartu, Tartu, 50406, Estonia

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

    Seoul, 06591, South Korea

  • The Moncton Hospital-Oncology ( Site 0307)

    Moncton, New Brunswick, E1C 6Z8, Canada

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

    Germantown, Tennessee, 38138, United States

  • UCLH-Cancer Clinical Trials Unit ( Site 1402)

    London-Camden, London, City of, NW1 2PG, United Kingdom

  • UPMC Hillman Cancer Center ( Site 1516)

    Pittsburgh, Pennsylvania, 15232, United States

  • UT Southwestern Medical Center ( Site 1551)

    Dallas, Texas, 75390, United States

  • UZ Brussel ( Site 0105)

    Brussels, Bruxelles-Capitale, Region de, 1090, Belgium

  • UZ Leuven ( Site 0101)

    Leuven, Vlaams-Brabant, 3000, Belgium

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

    Dresden, Saxony, 01307, Germany

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

    Athens, Georgia, 30607, United States

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

    Heraklion, Irakleio, 715 00, Greece

  • University Hospital Coventry & Warwickshire ( Site 1406)

    Coventry, CV2 2DX, United Kingdom

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

    Chicago, Illinois, 60637, United States

  • Universitätsklinikum Marburg ( Site 0610)

    Marburg, Hesse, 35043, Germany

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

    Yvoir, Namur, 5530, Belgium

  • VILNIUS UNIVERSITY HOSPITAL SANTAROS KLINIKOS ( Site 2403)

    Vilnius, 08460, Lithuania

  • Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 1509)

    Nashville, Tennessee, 37232, United States

  • Velindre Cancer Centre-Research and Development ( Site 1415)

    Cardiff, CF14 2TL, United Kingdom

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