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NCT07284849PHASE3Recruiting

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

Incyte Corporation

Start Date

3/5/2026

Completion Date

9/28/2029

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Stage IV colorectal adenocarcinoma not amenable to curative resection. * No prior systemic treatment for unresectable or metastatic disease. Participants who received adjuvant or neoadjuvant therapy may enroll if there was no recurrence within 12 months of the end of treatment. * Measurable disease per RECIST v1.1. * ECOG performance status of 0 or 1. * Adequate organ function determined by laboratory results. Exclusion Criteria: * MSI-H/dMMR per historical data in the medical record. * BRAF V600E mutation per historical data in the medical record. * Untreated and/or progressing CNS metastases. * History of other malignancy within 2 years. * Treatment with an anti-PD-(L)1 or other immune checkpoint inhibitor for any indication within the last 3 years. * Active autoimmune disease that has required systemic treatment in the past 2 years. * Significant concurrent and/or uncontrolled medical condition. * History of organ transplant, including allogeneic stem cell transplantation. Other protocol-defined inclusion/exclusion criteria apply.

Interventions

DRUG

INCA33890

DRUG

Placebo

DRUG

Bevacizumab

DRUG

FOLFOX

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Conditions

CRC (Colorectal Cancer)

Locations

The University of Arizona Cancer Center

Tucson, Arizona 85719

United States

Roche Tissue Diagnostics, Companion Diagnostics

Tucson, Arizona 85755

United States

Memorial Care Orange Coast Medical Center

Fountain Valley, California 92708

United States

Providence Medical Foundation

Fullerton, California 92835

United States

Cancer & Blood Research Center

Los Alamitos, California 90720

United States

University of California Los Angeles Health

Los Angeles, California 90095

United States

Sarah Cannon Research Institute Scri Oncology Partners

Aurora, Colorado 80012

United States

Hartford Hospital

Hartford, Connecticut 06102

United States

George Washington University

Washington D.C., District of Columbia 20037

United States

Florida Oncology & Hematology

Fort Myers, Florida 33912

United States

University of Florida Health

Gainesville, Florida 32610

United States

Sylvester Comprehensive Cancer Center

Miami, Florida 33136

United States

Advent Health

Orlando, Florida 32804

United States

Orlando Health Cancer Institute Downtown Orlando

Orlando, Florida 32806

United States

Ascension Sacred Heart Pensacola

Pensacola, Florida 32504

United States

Tampa General Hospital-Cancer Institute

Tampa, Florida 33606

United States

Piedmont Cancer Institute

Locust Grove, Georgia 30248

United States

University of Hawaii Cancer Center

Honolulu, Hawaii 96813-2402

United States

St Lukes Mountain States Tumor Institute Msti Boise

Boise, Idaho 83712

United States

Sih Cancer Institute

Carterville, Illinois 62918

United States

University of Illinois Cancer Center

Chicago, Illinois 60612

United States

Endeavor Health

Evanston, Illinois 60201

United States

Springfield Clinic

Springfield, Illinois 62703

United States

Community Health Network, Inc.

Indianapolis, Indiana 46250

United States

Hematology Oncology of Indiana

Indianapolis, Indiana 46260

United States

University of Iowa Hospital and Clinics

Iowa City, Iowa 52242

United States

Saint Agnes Hospital

Baltimore, Maryland 21229-5201

United States

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

Bethesda, Maryland 20817

United States

Sarah Cannon Research Institute Scri Oncology Partners

Brandywine, Maryland 20613

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Oncura Health

Boston, Massachusetts 02115

United States

St. Joseph Mercy Hospital

Ann Arbor, Michigan 48106

United States

Henry Ford Hospital

Detroit, Michigan 48202

United States

Missouri Cancer Associates

Columbia, Missouri 65201

United States

Saint Luke'S Hospital of Kansas City

Kansas City, Missouri 64111

United States

Midamerica Cancer Care

Kansas City, Missouri 64121

United States

Oncology Hematology Associates

Springfield, Missouri 65807

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Morristown Medical Center

Morristown, New Jersey 07960

United States

Presbyterian Rust Medical Center

Rio Rancho, New Mexico 87124

United States

Icahn School of Medicine At Mount Sinai

New York, New York 10019

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Ny Cancer and Blood Specialists

Shirley, New York 11967

United States

Montefiore Einstein For Cancer Care

The Bronx, New York 10461

United States

Messino Cancer Center

Asheville, North Carolina 28806

United States

The University of North Carolina At Chapel Hill

Chapel Hill, North Carolina 27514

United States

Oncology Specialists of Charlotte

Charlotte, North Carolina 28207

United States

University of Cincinnati Cancer Institute

Cincinnati, Ohio 45219

United States

Case Comprehensive Cancer Center

Cleveland, Ohio 44106

United States

Ohio State University-Arthur G James Comprehensive Cancer Center

Columbus, Ohio 43210

United States

Ohio Health

Columbus, Ohio 43214

United States

Alliance Cancer Specialists

Doylestown, Pennsylvania 18901

United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania 17033

United States

Hillman Cancer Center

Monroeville, Pennsylvania 15146

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Allegheny General Hospital Cancer Institute

Pittsburgh, Pennsylvania 15212

United States

Cancer Care Associates of York

York, Pennsylvania 17403

United States

Avera Cancer Institute

Sioux Falls, South Dakota 57105

United States

Provision Center For Biomedical Research

Knoxville, Tennessee 37909

United States

Ascension Seton Spclty Care Ctr

Austin, Texas 78712

United States

Texas Oncology

Austin, Texas 78745

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75235

United States

Md Anderson Cancer Center

Houston, Texas 77030

United States

Baylor Scott & White Health

Temple, Texas 76508

United States

University of Virginia Medical Center

Charlottesville, Virginia 22908

United States

Mary Washington Healthcare

Fredericksburg, Virginia 22405

United States

Shenandoah Oncology

Winchester, Virginia 22601

United States

Vandalia Health Charleston Area Medical Center

Charleston, West Virginia 25304

United States

West Virginia University Cancer Institute

Morgantown, West Virginia 26506

United States

Thedacare Medical Oncology

Appleton, Wisconsin 54911

United States

Hospital Britanico de Buenos Aires

Buenos Aires, 01280

Argentina

Investigaciones Clinicas Moleculares Icm

Buenos Aires, 01425

Argentina

Centro Medico Austral

Ciudad Autonoma Buenos Aires, 01019

Argentina

Instituto Medico Especializado Alexander Fleming

Ciudad Autonoma Buenos Aires, 01426

Argentina

Hospital Italiano de Buenos Aires

Ciudad Autonoma Buenos Aires, C1199ABB

Argentina

Instituto de Investigaciones Clinicas Cordoba S.A.

Córdoba, X5000AAW

Argentina

Hospital Privado Centro Medico de Cordoba S.A

Córdoba, X5016KEH

Argentina

Centro Oncologico Riojano Integral (Cori)

La Rioja, 05300

Argentina

Investigaciones Oncologicas C Colon

Mar del Plata, 07600

Argentina

Instituto de Oncologia de Rosario

Rosario, S2000KZE

Argentina

Exelsus Srl

San Miguel de Tucumán, T4000IAN

Argentina

Kinghorn Cancer Centre

Darlinghurst, New South Wales 02010

Australia

Port Macquarie Base Hospital

Port Macquarie, New South Wales 02444

Australia

Prince of Wales Hospital Au

Randwick, New South Wales 02031

Australia

Calvary Mater Newcastle

Waratah, New South Wales 02298

Australia

Westmead Hospital

Westmead, New South Wales 02046

Australia

Wollongong Hospital

Wollongong, New South Wales 02500

Australia

Gold Coast University Hospital

Southport, Queensland 04215

Australia

Townsville Cancer Centre

Townsville, Queensland 04814

Australia

Princess Alexandra Hospital Australia

Woolloongabba, Queensland 04102

Australia

Icon Cancer Centre Kurralta Park

Kurralta Park, South Australia 05037

Australia

Box Hill Hospital

Box Hill, Victoria 03128

Australia

Austin Hospital

Heidelberg, Victoria 03084

Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria 03000

Australia

The Alfred Hospital

Melbourne, Victoria 03004

Australia

The Canberra Hospital

Canberra, 02605

Australia

Fiona Stanley Hospital

Murdoch, 06150

Australia

Lkh - Universitaetsklinikum Graz

Graz, 08036

Austria

Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz

Linz, 04010

Austria

Lkh - Universitatsklinikum Der Pmu Salzburg

Salzburg, 05020

Austria

C.H.U. Brugmann - Site Victor Horta

Brussels, 01020

Belgium

Universitair Ziekenhuis Brussel

Brussels, 01090

Belgium

Cliniques Universitaires Ucl Saint-Luc

Brussels, 01200

Belgium

Universitair Ziekenhuis Antwerpen (Uza)

Edegem, 02650

Belgium

Universitair Ziekenhuis Gent (Uz Gent)

Ghent, 09000

Belgium

Universitaire Ziekenhuis Leuven - Gasthuisberg

Leuven, 03000

Belgium

Chu Ucl Namur University Hospital Mont-Godinne

Yvoir, 05530

Belgium

Fundacao Pio Xii Hospital de Cancer de Barretos

Barretos, 14784400

Brazil

Centro de Pesquisas Clinica Reichow

Blumenau, 89010-340

Brazil

Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Cancer

Curitiba, 81520-060

Brazil

Oncosite - Centro de Pesquisa Clinica E Oncologia

Ijuí, 98700-000

Brazil

Clinica de Neoplasias Litoral Ltda

Itajaí, 88301-220

Brazil

Hospital Bruno Born

Lajeado, 95900-000

Brazil

Liga Norte-Rio-Grandense Contra O Câncer

Natal, 59062-000

Brazil

Irmandade Da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, 90020-090

Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, 90035-903

Brazil

Hgb - Hospital Giovanni Battista - Mae de Deus Center

Porto Alegre, 90110-270

Brazil

Hospital Moinhos de Vento

Porto Alegre, 90560032

Brazil

Hospital Das Clínicas Fmrp-Usp

Ribeirão Preto, 14051-140

Brazil

Nob - Nucleo de Oncologia Da Bahia

Salvador, 40170-110

Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

SAO JOSE RIO Preto, 15090-000

Brazil

Ceon Pesquisas

São Caetano do Sul, 09541-270

Brazil

Icavc - Instituto Do Câncer Arnaldo Vieira de Carvalho

São Paulo, 01209-000

Brazil

Cross Cancer Institute

Edmonton, Alberta T6G 1Z2

Canada

Juravinski Cancer Clinic

Hamilton, Ontario L8V5C2

Canada

Sunnybrook Research Institute

Toronto, Ontario M4N 3M5

Canada

Princess Margaret Cancer Center

Toronto, Ontario M5G 2M9

Canada

Cisss de La Monteregie Centre

Greenfield Park, Quebec J4V 2H1

Canada

Hotel-Dieu de Levis

Lévis, Quebec G6V 3Z1

Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan S7N 4H4

Canada

Aalborg Universitetshospital

Aalborg, 09000

Denmark

OUH

Odense C, 05000

Denmark

Sjaellands Universitetshospital

Roskilde, 04000

Denmark

Sygehus Lillebælt - Vejle

Vejle, 07100

Denmark

Institut de Cancerologie de L'Ouest

Angers, 49055

France

Chu Bordeaux-Hopital Pellegrin

Bordeaux, 33076

France

Hôpital de La Timone

Marseille, 13385

France

Hospital Universitaire Pitie-Salpetriere

Paris, 75013

France

Hôpital Européen Georges Pompidou

Paris, 75015

France

Hospital de La Miletrie

Poitiers, 86021

France

Chu de Reims

Reims, 51100

France

University Hospital of Saint Etienne

Saint-Priest-en-Jarez, 42270

France

Chu Toulouse Hopital Rangueil

Toulouse, 31059

France

Institut Gustave Roussy

Villejuif, 94800

France

High Technology Hospital Medcenter

Batumi, 06004

Georgia

Jsc Evex Hospitals

Kutaisi, 04600

Georgia

Aversi Clinic Ltd

Marneuli, 03000

Georgia

Israel-Georgian Medical Research Clinic Helsicore

Tbilisi, 00112

Georgia

Todua Clinic, Llc

Tbilisi, 00112

Georgia

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

Tbilisi, 00144

Georgia

Institute of Clinical Oncology Ltd

Tbilisi, 00159

Georgia

K. Eristavi National Center of Experimental and Clinical Surgery

Tbilisi, 00159

Georgia

Caucasus Medical Centre Llc

Tbilisi, 00186

Georgia

Medulla Chemotherapy and Immunotherapy Clinic

Tbilisi, 00186

Georgia

Charite - Campus Virchow-Klinikum

Berlin, 13353

Germany

University Hospital Carl Gustav Carus

Dresden, 01307

Germany

Universitaetsklinikum Essen

Essen, 45147

Germany

Krankenhaus Nordwest Gmbh

Frankfurt am Main, 60488

Germany

University Medical Center Freiburg

Freiburg im Breisgau, 79106

Germany

University Medical Centre Hamburg-Eppendorf Centre of Oncology

Hamburg, 20246

Germany

Asklepios Klinik Altona

Hamburg, 22763

Germany

Hannover Medical School

Hanover, 30625

Germany

Uksh Campus Lubeck

Lübeck, 23538

Germany

Klinikum Der University Munchen - Campus Grosshadern

München, 81377

Germany

Klinikum Neuperlach

München, 81737

Germany

Roche Diagnostics Gmbh

Penzberg, 82377

Germany

Universitaetsklinikum Regensburg

Regensburg, 93053

Germany

Universitatkinikums Ulm

Ulm, 89081

Germany

Azienda Ospedaliero Universitaria Delle Marche

Ancona, 60020

Italy

Irccs Centro Di Riferimento Oncologico

Aviano, 33081

Italy

Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

Bari, 70124

Italy

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25124

Italy

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

Candiolo, 10060

Italy

Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi

Catania, 95122

Italy

Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

Milan, 20133

Italy

Asst Grande Ospedale Metropolitano Niguarda

Milan, 20162

Italy

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

Naples, 80131

Italy

Iov - Istituto Oncologico Veneto Irccs

Padova, 35128

Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126

Italy

Ospedale Santa Maria Delle Croci

Ravenna, 48100

Italy

Arcispedale S. Maria Nuova Azienda Ospedaliera Di Reggio Emilia

Reggio Emilia, 42121

Italy

Azienda Ospedaliera San Camillo Forlanini

Roma, 00152

Italy

Irccs Istituto Clinico Humanitas

Rozzano, 20089

Italy

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

San Giovanni Rotondo, 71013

Italy

Centro Ricerche Cliniche Di Verona

Verona, 37134

Italy

Hyogo Cancer Center

Akashi-shi, 673-8558

Japan

Chiba Cancer Center

Chiba, 260-8717

Japan

National Cancer Center Hospital

Chūōku, 104-0045

Japan

Nho Kyushu Cancer Center

Fukuoka, 811-1395

Japan

Saitama Medical University International Medical Center

Hidaka-shi, 350-1298

Japan

National Cancer Center Hospital East

Kashiwa-shi, 277-8577

Japan

St. Marianna University Hospital

Kawasaki-shi, 216-8511

Japan

Kagawa University Hospital

Kita-gun, 761-0793

Japan

Kobe City Hospital Organization Kobe City Medical Center General Hospital

Kobe, 650-0047

Japan

Cancer Institute Hospital of Jfcr

Kōtoku, 135-8550

Japan

Kochi Medical School Hospital

Nankoku-shi, 783-8505

Japan

Osaka International Cancer Institute

Osaka, 541-8567

Japan

Shizuoka Cancer Center

Shizuoka, 411-8777

Japan

The University of Osaka Hospital

Suita-shi, 565-0871

Japan

Kanagawa Cancer Center

Yokohama, 241-8515

Japan

Meander Medisch Centrum

Amersfoort, 3818 TZ

Netherlands

Martini Ziekenhuis

Groningen, 9728 NT

Netherlands

Maastricht Umc+

Maastricht, 6229 HX

Netherlands

Erasmus Medical Center

Rotterdam, 3015 GD

Netherlands

Haukeland Universitetssjukehus

Bergen, 05021

Norway

Akershus Universitetssykehus Hf

Lørenskog, 01478

Norway

Utprovingsenheten, Oslo University Hospital Radiumhospitalet

Oslo, 00379

Norway

Universitetssykehuset I Trondheim - St. Olavs Hospital

Trondheim, 07030

Norway

Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej

Jelenia Góra, 58-506

Poland

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

Siedlce, 08-110

Poland

Luxmed Onkologia Sp. Z O.O.

Warsaw, 01-748

Poland

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

Warsaw, 02-034

Poland

Pan American Center For Oncology Trials Llc Dorado Office

Dorado, 00646

Puerto Rico

Samsung Changwon Hospital

Changwon-si, 51353

South Korea

National Cancer Center

Goyang-si, 10408

South Korea

Seoul National University Bundang Hospital

Seongnam, 13620

South Korea

Cha Bundang Medical Center

Seongnam-si, 13496

South Korea

Korea University Anam Hospital

Seoul, 02841

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Kangbuk Samsung Hospital

Seoul, 03181

South Korea

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

Seoul, 03312

South Korea

Severance Hospital Yonsei University Health System

Seoul, 03722

South Korea

Hanyang University Seoul Hospital

Seoul, 04763

South Korea

Asan Medical Center

Seoul, 05505

South Korea

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

Seoul, 06591

South Korea

Ajou University Hospital

Suwon, 16499

South Korea

Hospital Universitari Germans Trias I Pujol

Badalona, 08916

Spain

Hospital General Universitario Vall D Hebron

Barcelona, 08035

Spain

Hospital Clinic Barcelona Main

Barcelona, 08036

Spain

Hospital de La Santa Creu I Sant Pau

Barcelona, 08041

Spain

Complejo Hospitalario Universitario Insular-Materno Infantil

Las Palmas de Gran Canaria, 35016

Spain

Hospital General Universitario Gregorio Maranon

Madrid, 28007

Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, 28220

Spain

Son Espases University Hospital

Palma de Mallorca, 07120

Spain

Hospital Universitario de Navarra

Pamplona, 31008

Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, 28223

Spain

Hospital Universitario Marques de Valdecilla

Santander, 39012

Spain

Hospital Universitari Mutua de Terrassa

Terrassa, 08221

Spain

Instituto Valenciano de Oncologia

Valencia, 46009

Spain

Hospital Clinico Universitario de Valencia

Valencia, 46010

Spain

Hospital Universitario Miguel Servet

Zaragoza, 50009

Spain

Inselspital - Universitaetsspital Bern

Bern, 03010

Switzerland

Chuv, Lausanne University Hospital

Lausanne, 01005

Switzerland

Hoch Health Ostschweiz

Sankt Gallen, 09007

Switzerland

Bristol Haematology and Oncology Centre

Bristol, BS2 8ED

United Kingdom

Velindre Cancer Centre

Cardiff, CF14 2TL

United Kingdom

St James University Hospital

Leeds, LS9 7TF

United Kingdom

Barts Hospital

London, EC1A 7BE

United Kingdom

Guys Hospital

London, SE1 9RT

United Kingdom

Royal Marsden Hospital - Fulham

London, SW3 6JJ

United Kingdom

Kent Oncology Centre - Maidstone Hospital

Maidstone, ME16 9QQ

United Kingdom

The Christie Nhs Foundation Trust Uk

Manchester, M20 4BX

United Kingdom

The Royal Marsden Nhs Foundation Trust - Sutton

Sutton, SM2 5PT

United Kingdom