RecruitingPhase 3NCT07284849

A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer

A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer


Sponsor

Incyte Corporation

Enrollment

700 participants

Start Date

Mar 5, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy and safety of standard-of-care chemotherapy and bevacizumab with or without INCA33890 in the first-line treatment of metastatic microsatellite stable colorectal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is adding a new drug called INCA33890 to standard chemotherapy and bevacizumab (a drug that cuts off blood supply to tumors) as a first-line treatment for people with advanced colorectal cancer that cannot be surgically removed. **You may be eligible if...** - You have stage IV colorectal cancer that cannot be cured with surgery - You have not yet received any treatment for your advanced or metastatic disease - You have measurable tumors on imaging - Your performance level is good (ECOG 0 or 1 — able to carry out daily activities) - Your liver, kidneys, and blood counts are within acceptable ranges **You may NOT be eligible if...** - Your tumor has specific molecular markers: MSI-H/dMMR (high mutation rate) or BRAF V600E mutation - You have untreated brain metastases - You have had another cancer in the last 2 years - You have received immune checkpoint inhibitor therapy in the last 3 years - You have an active autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGINCA33890

INCA33890 will be administered at protocol defined dose.

DRUGPlacebo

Placebo will be administered at protocol defined dose.

DRUGBevacizumab

Bevacizumab will be administered at protocol defined dose.

DRUGFOLFOX

FOLFOX will be administered at protocol defined dose.


Locations(272)

Ironwood Cancer & Research Centers

Chandler, Arizona, United States

The University of Arizona Cancer Center

Tucson, Arizona, United States

Roche Tissue Diagnostics, Companion Diagnostics

Tucson, Arizona, United States

Los Angeles Cancer Network

Anaheim, California, United States

Toi Clinical Research

Cerritos, California, United States

Providence Medical Foundation

Fullerton, California, United States

Long Beach Medical Center

Long Beach, California, United States

University of California Los Angeles Health

Los Angeles, California, United States

Sarah Cannon Research Institute Scri Oncology Partners

Aurora, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

George Washington University

Washington D.C., District of Columbia, United States

Florida Oncology & Hematology

Fort Myers, Florida, United States

University of Florida Health

Gainesville, Florida, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Advent Health

Orlando, Florida, United States

Orlando Health Cancer Institute Downtown Orlando

Orlando, Florida, United States

Ascension Sacred Heart Pensacola

Pensacola, Florida, United States

Tampa General Hospital-Cancer Institute

Tampa, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute Hospital

Tampa, Florida, United States

Piedmont Cancer Institute

Locust Grove, Georgia, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

St Lukes Mountain States Tumor Institute Msti Boise

Boise, Idaho, United States

University of Illinois Cancer Center

Chicago, Illinois, United States

Endeavor Health

Evanston, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Iu Simon Cancer Center

Indianapolis, Indiana, United States

Community Health Network, Inc.

Indianapolis, Indiana, United States

Hematology Oncology of Indiana

Indianapolis, Indiana, United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Ochsner Clinic Foundation Ocf Ochsner Cancer Institute Oci

New Orleans, Louisiana, United States

New England Cancer Specialists

Scarborough, Maine, United States

Saint Agnes Hospital

Baltimore, Maryland, United States

Cancer Center For Blood Disorders A Division of American Oncology Partners P.A

Bethesda, Maryland, United States

Sarah Cannon Research Institute Scri Oncology Partners

Brandywine, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

St. Joseph Mercy Hospital

Ann Arbor, Michigan, United States

University of Michigan

Ann Arbor, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Missouri Cancer Associates

Columbia, Missouri, United States

Saint Luke'S Hospital of Kansas City

Kansas City, Missouri, United States

Midamerica Cancer Care

Kansas City, Missouri, United States

Oncology Hematology Associates

Springfield, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Morristown Medical Center

Morristown, New Jersey, United States

Presbyterian Healthcare Services

Albuquerque, New Mexico, United States

Monter Cancer Center

New Hyde Park, New York, United States

Icahn School of Medicine At Mount Sinai

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

Ny Cancer and Blood Specialists

Shirley, New York, United States

Montefiore Einstein For Cancer Care

The Bronx, New York, United States

Messino Cancer Center

Asheville, North Carolina, United States

The University of North Carolina At Chapel Hill

Chapel Hill, North Carolina, United States

Oncology Specialists of Charlotte

Charlotte, North Carolina, United States

University of Cincinnati Cancer Institute

Cincinnati, Ohio, United States

Ohio State University-Arthur G James Comprehensive Cancer Center

Columbus, Ohio, United States

Ohio Health

Columbus, Ohio, United States

Alliance Cancer Specialists

Doylestown, Pennsylvania, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Hillman Cancer Center

Monroeville, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Sidney Kimmel Comprehensive Cancer Center

Philadelphia, Pennsylvania, United States

Allegheny General Hospital Cancer Institute

Pittsburgh, Pennsylvania, United States

Cancer Care Associates of York

York, Pennsylvania, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Provision Center For Biomedical Research

Knoxville, Tennessee, United States

Sarah Cannon Research Institute Scri Oncology Partners

Nashville, Tennessee, United States

Tennessee Oncology, Pllc

Nashville, Tennessee, United States

Ascension Seton Spclty Care Ctr

Austin, Texas, United States

Texas Oncology

Austin, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Md Anderson Cancer Center

Houston, Texas, United States

Baylor Scott & White Health

Temple, Texas, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Shenandoah Oncology

Winchester, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Cancer Care Northwest

Spokane, Washington, United States

Vandalia Health Charleston Area Medical Center

Charleston, West Virginia, United States

West Virginia University Cancer Institute

Morgantown, West Virginia, United States

Hospital Britanico de Buenos Aires

Buenos Aires, Argentina

Investigaciones Clinicas Moleculares Icm

Buenos Aires, Argentina

Instituto Medico Especializado Alexander Fleming

Buenos Aires, Argentina

Centro Medico Austral

Ciudad Autonoma Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Cordoba S.A.

Córdoba, Argentina

Hospital Privado Centro Medico de Cordoba S.A

Córdoba, Argentina

Centro Oncologico Riojano Integral (Cori)

La Rioja, Argentina

Investigaciones Oncologicas C Colon

Mar del Plata, Argentina

Instituto de Oncologia de Rosario

Rosario, Argentina

Exelsus Srl

San Miguel de Tucumán, Argentina

Border Cancer Hospital Dispensary - Albury Wodonga Regional Cancer Centre

Albury, New South Wales, Australia

Kinghorn Cancer Centre

Darlinghurst, New South Wales, Australia

Port Macquarie Base Hospital

Port Macquarie, New South Wales, Australia

Prince of Wales Hospital Au

Randwick, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

Townsville Cancer Centre

Townsville, Queensland, Australia

Princess Alexandra Hospital Australia

Woolloongabba, Queensland, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Icon Cancer Centre Kurralta Park

Kurralta Park, South Australia, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Austin Hospital

Heidelberg, Victoria, Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

The Canberra Hospital

Canberra, Australia

Fiona Stanley Hospital

Murdoch, Australia

Lkh - Universitaetsklinikum Graz

Graz, Austria

Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz

Linz, Austria

Lkh - Universitatsklinikum Der Pmu Salzburg

Salzburg, Austria

Akh - Medizinische Universität Wien

Vienna, Austria

Universitair Ziekenhuis Brussel

Brussels, Belgium

Cliniques Universitaires Ucl Saint-Luc

Brussels, Belgium

Universitair Ziekenhuis Antwerpen (Uza)

Edegem, Belgium

Universitair Ziekenhuis Gent (Uz Gent)

Ghent, Belgium

Universitaire Ziekenhuis Leuven - Gasthuisberg

Leuven, Belgium

Chu Ucl Namur University Hospital Mont-Godinne

Yvoir, Belgium

Fundacao Pio Xii Hospital de Cancer de Barretos

Barretos, Brazil

Centro de Pesquisas Clinica Reichow

Blumenau, Brazil

Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Cancer

Curitiba, Brazil

Oncosite - Centro de Pesquisa Clinica E Oncologia

Ijuí, Brazil

Clinica de Neoplasias Litoral Ltda

Itajaí, Brazil

Hospital Bruno Born

Lajeado, Brazil

Liga Norte-Rio-Grandense Contra O Câncer

Natal, Brazil

Irmandade Da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Brazil

Hgb - Hospital Giovanni Battista - Mae de Deus Center

Porto Alegre, Brazil

Hospital Moinhos de Vento

Porto Alegre, Brazil

Hospital Das Clínicas Fmrp-Usp

Ribeirão Preto, Brazil

Nob - Nucleo de Oncologia Da Bahia

Salvador, Brazil

Ceon Pesquisas

Santo André, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

SAO JOSE RIO Preto, Brazil

Icavc - Instituto Do Câncer Arnaldo Vieira de Carvalho

São Paulo, Brazil

Cross Cancer Institute

Edmonton, Alberta, Canada

Juravinski Cancer Clinic

Hamilton, Ontario, Canada

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Hotel-Dieu de Levis

Lévis, Quebec, Canada

McGill University Health Centre Research Institute

Montreal, Quebec, Canada

Aalborg Universitetshospital

Aalborg, Denmark

Rigshospitalet

Copenhagen, Denmark

OUH

Odense C, Denmark

Sjaellands Universitetshospital

Roskilde, Denmark

Sygehus Lillebælt - Vejle

Vejle, Denmark

Institut de Cancerologie de L'Ouest

Angers, France

Chu Bordeaux-Hopital Pellegrin

Bordeaux, France

Institut Paoli Calmettes

Marseille, France

Hôpital de La Timone

Marseille, France

Hospital Universitaire Pitie-Salpetriere

Paris, France

Hôpital Européen Georges Pompidou

Paris, France

Hospital de La Miletrie

Poitiers, France

Chu de Reims

Reims, France

University Hospital of Saint Etienne

Saint-Etienne, France

Chu Toulouse Hopital Rangueil

Toulouse, France

Institut Gustave Roussy

Villejuif, France

High Technology Hospital Medcenter

Batumi, Georgia

Jsc Evex Hospitals

Kutaisi, Georgia

Aversi Clinic Ltd

Marneuli, Georgia

Israel-Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

Todua Clinic, Llc

Tbilisi, Georgia

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Llc

Tbilisi, Georgia

Institute of Clinical Oncology Ltd

Tbilisi, Georgia

K. Eristavi National Center of Experimental and Clinical Surgery

Tbilisi, Georgia

Caucasus Medical Centre Llc

Tbilisi, Georgia

Medulla Chemotherapy and Immunotherapy Clinic

Tbilisi, Georgia

Charite - Campus Virchow-Klinikum

Berlin, Germany

University Hospital Carl Gustav Carus

Dresden, Germany

Universitaetsklinikum Essen

Essen, Germany

Krankenhaus Nordwest Gmbh

Frankfurt am Main, Germany

University Medical Center Freiburg

Freiburg im Breisgau, Germany

University Medical Centre Hamburg-Eppendorf Centre of Oncology

Hamburg, Germany

Haematologisch-Onkologischen Praxis Eppendorf (Hope)

Hamburg, Germany

Asklepios Klinik Altona

Hamburg, Germany

Hannover Medical School

Hanover, Germany

Universitaetsklinikum Leipzig Aoer

Leipzig, Germany

Uksh Campus Lubeck

Lübeck, Germany

Klinikum Der University Munchen - Campus Grosshadern

München, Germany

Klinikum Neuperlach

München, Germany

Roche Diagnostics Gmbh

Penzberg, Germany

Universitaetsklinikum Regensburg

Regensburg, Germany

Universitatkinikums Ulm

Ulm, Germany

Azienda Ospedaliero Universitaria Delle Marche

Ancona, Italy

Irccs Centro Di Riferimento Oncologico

Aviano, Italy

Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

Bari, Italy

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, Italy

Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia - Irccs

Candiolo, Italy

Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

Milan, Italy

Asst Grande Ospedale Metropolitano Niguarda

Milan, Italy

Azienda Ospedaliera Universitaria- Università Degli Studi Della Campania "Luigi Vanvitelli"

Naples, Italy

Iov - Istituto Oncologico Veneto Irccs

Padova, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Ospedale Santa Maria Delle Croci

Ravenna, Italy

Arcispedale S. Maria Nuova Azienda Ospedaliera Di Reggio Emilia

Reggio Emilia, Italy

Azienda Ospedaliera San Camillo Forlanini

Roma, Italy

Agostino Gemelli Policlinico Universitario

Rome, Italy

Irccs Istituto Clinico Humanitas

Rozzano, Italy

I.R.C.C.S. Casa Sollievo Della Sofferenza

San Giovanni Rotondo, Italy

Centro Ricerche Cliniche Di Verona

Verona, Italy

Hyogo Cancer Center

Akashi-shi, Japan

Chiba Cancer Center

Chiba, Japan

National Cancer Center Hospital

Chūōku, Japan

Nho Kyushu Cancer Center

Fukuoka, Japan

Saitama Medical University International Medical Center

Hidaka-shi, Japan

National Cancer Center Hospital East

Kashiwa-shi, Japan

St. Marianna University Hospital

Kawasaki-shi, Japan

Kagawa University Hospital

Kita-gun, Japan

Kobe City Hospital Organization Kobe City Medical Center General Hospital

Kobe, Japan

Cancer Institute Hospital of Jfcr

Kōtoku, Japan

Nho Shikoku Cancer Center

Matsuyama, Japan

Kochi Medical School Hospital

Nankoku-shi, Japan

Osaka International Cancer Institute

Osaka, Japan

The University of Osaka Hospital

Suita-shi, Japan

Shizuoka Cancer Center

Sunto-gun, Japan

Kanagawa Cancer Center

Yokohama, Japan

Meander Medisch Centrum

Amersfoort, Netherlands

Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, Netherlands

Amsterdam Umc

Amsterdam, Netherlands

Martini Ziekenhuis

Groningen, Netherlands

Maastricht Umc+

Maastricht, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

University Medical Center Utrecht

Utrecht, Netherlands

Haukeland Universitetssjukehus

Bergen, Norway

Akershus Universitetssykehus Hf

Lørenskog, Norway

Utprovingsenheten, Oslo University Hospital Radiumhospitalet

Oslo, Norway

Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej

Jelenia Góra, Poland

Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie

Rzeszów, Poland

Mazowiecki Szpital Wojewodzki Im. SW. Jana Pawla Ii W Siedlcach Sp Z O O

Siedlce, Poland

Luxmed Onkologia Sp. Z O.O.

Warsaw, Poland

Narodowy Instytut Onkologii Im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

Warsaw, Poland

Pan American Center For Oncology Trials Llc Dorado Office

Dorado, Puerto Rico

Samsung Changwon Hospital

Changwon-si, South Korea

National Cancer Center

Goyang-si, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Cha Bundang Medical Center

Seongnam-si, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

The Catholic University of Korea, Eunpyeong St. Mary'S Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Hanyang University Seoul Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St. Mary'S Hospital

Seoul, South Korea

Ajou University Hospital

Suwon, South Korea

Hospital Universitari Germans Trias I Pujol

Badalona, Spain

Hospital General Universitario Vall D Hebron

Barcelona, Spain

Hospital Clinic Barcelona Main

Barcelona, Spain

Hospital de La Santa Creu I Sant Pau

Barcelona, Spain

Complejo Hospitalario Universitario Insular-Materno Infantil

Las Palmas de Gran Canaria, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, Spain

Son Espases University Hospital

Palma de Mallorca, Spain

Hospital Universitario de Navarra

Pamplona, Spain

Hospital Universitario Marques de Valdecilla

Santander, Spain

Hospital Universitari Mutua de Terrassa

Terrassa, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Hospital General Universitario de Valencia

Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Inselspital - Universitaetsspital Bern

Bern, Switzerland

Chuv, Lausanne University Hospital

Lausanne, Switzerland

Hoch Health Ostschweiz

Sankt Gallen, Switzerland

Bristol Haematology and Oncology Centre

Bristol, United Kingdom

Velindre Cancer Centre

Cardiff, United Kingdom

St James University Hospital

Leeds, United Kingdom

Barts Hospital

London, United Kingdom

Guys Hospital

London, United Kingdom

Kent Oncology Centre - Maidstone Hospital

Maidstone, United Kingdom

The Christie Nhs Foundation Trust Uk

Manchester, United Kingdom

The Royal Marsden Nhs Foundation Trust - Sutton

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07284849


Related Trials