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

May 21, 2026 updated by: Incyte Corporation

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

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.

Study Overview

Status

Recruiting

Conditions

CRC (Colorectal Cancer)

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

700

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Incyte Corporation Call Center (US)
Phone Number: 1.855.463.3463
Email: medinfo@incyte.com

Study Contact Backup

Name: Incyte Corporation Call Center (ex-US)
Phone Number: +800 00027423
Email: eumedinfo@incyte.com

Study Locations

Argentina
- - Buenos Aires, Argentina, C1426ANZ
    - Not yet recruiting
    - Instituto Medico Especializado Alexander Fleming
  - Buenos Aires, Argentina, 01280
    - Not yet recruiting
    - Hospital Británico de Buenos Aires
  - Buenos Aires, Argentina, 01425
    - Not yet recruiting
    - Investigaciones Clinicas Moleculares Icm
  - Ciudad Autonoma Buenos Aires, Argentina, C1199ABB
    - Not yet recruiting
    - Hospital Italiano de Buenos Aires
  - Ciudad Autonoma Buenos Aires, Argentina, C1019ABS
    - Not yet recruiting
    - Centro Medico Austral
  - Córdoba, Argentina, X5000AAW
    - Not yet recruiting
    - Instituto de Investigaciones Clínicas Córdoba S.A.
  - Córdoba, Argentina, X5016KEH
    - Not yet recruiting
    - Hospital Privado Centro Medico de Cordoba S.A
  - La Rioja, Argentina, F5300COE
    - Not yet recruiting
    - Centro Oncologico Riojano Integral (Cori)
  - Mar del Plata, Argentina, 07600
    - Not yet recruiting
    - Investigaciones Oncologicas C Colon
  - Rosario, Argentina, 02000
    - Not yet recruiting
    - Instituto de Oncología de Rosario
  - San Miguel de Tucumán, Argentina, 04000
    - Not yet recruiting
    - Exelsus Srl
Australia
- - Canberra, Australia, 02605
    - Not yet recruiting
    - The Canberra Hospital
  - Murdoch, Australia, 06150
    - Not yet recruiting
    - Fiona Stanley Hospital
- New South Wales
  - Albury, New South Wales, Australia, 02640
    - Not yet recruiting
    - Border Cancer Hospital Dispensary - Albury Wodonga Regional Cancer Centre
  - Darlinghurst, New South Wales, Australia, 02010
    - Not yet recruiting
    - Kinghorn Cancer Centre
  - Port Macquarie, New South Wales, Australia, 02444
    - Not yet recruiting
    - Port Macquarie Base Hospital
  - Randwick, New South Wales, Australia, 02031
    - Not yet recruiting
    - Prince of Wales Hospital Au
  - Waratah, New South Wales, Australia, 02298
    - Not yet recruiting
    - Calvary Mater Newcastle
  - Westmead, New South Wales, Australia, 02046
    - Not yet recruiting
    - Westmead Hospital
  - Wollongong, New South Wales, Australia, 02500
    - Not yet recruiting
    - Wollongong Hospital
- Queensland
  - Southport, Queensland, Australia, 04215
    - Not yet recruiting
    - Gold Coast University Hospital
  - Townsville, Queensland, Australia, 04814
    - Not yet recruiting
    - Townsville Cancer Centre
  - Woolloongabba, Queensland, Australia, 04102
    - Not yet recruiting
    - Princess Alexandra Hospital Australia
- South Australia
  - Bedford Park, South Australia, Australia, 05042
    - Withdrawn
    - Flinders Medical Centre
  - Kurralta Park, South Australia, Australia, 05037
    - Not yet recruiting
    - Icon Cancer Centre Kurralta Park
- Victoria
  - Box Hill, Victoria, Australia, 03128
    - Not yet recruiting
    - Box Hill Hospital
  - Heidelberg, Victoria, Australia, 03084
    - Not yet recruiting
    - Austin Hospital
  - Melbourne, Victoria, Australia, 03004
    - Not yet recruiting
    - The Alfred Hospital
  - Melbourne, Victoria, Australia, 03000
    - Not yet recruiting
    - Peter Maccallum Cancer Centre
Austria
- - Graz, Austria, 08036
    - Not yet recruiting
    - Lkh - Universitaetsklinikum Graz
  - Linz, Austria, 04010
    - Not yet recruiting
    - Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz
  - Salzburg, Austria, 05020
    - Not yet recruiting
    - Lkh - Universitatsklinikum Der Pmu Salzburg
  - Vienna, Austria, 01090
    - Not yet recruiting
    - Akh - Medizinische Universität Wien
Belgium
- - Brussels, Belgium, 01200
    - Not yet recruiting
    - Cliniques Universitaires Ucl Saint-Luc
  - Brussels, Belgium, 01090
    - Not yet recruiting
    - Universitair Ziekenhuis Brussel
  - Brussels, Belgium, 01020
    - Not yet recruiting
    - C.H.U. Brugmann - Site Victor Horta
  - Edegem, Belgium, 02650
    - Not yet recruiting
    - Universitair Ziekenhuis Antwerpen (UZA)
  - Ghent, Belgium, 09000
    - Not yet recruiting
    - Universitair Ziekenhuis Gent (Uz Gent)
  - Leuven, Belgium, 03000
    - Not yet recruiting
    - Universitaire Ziekenhuis Leuven - Gasthuisberg
  - Yvoir, Belgium, 05530
    - Not yet recruiting
    - Chu Ucl Namur University Hospital Mont-Godinne
Brazil
- - Barretos, Brazil, 14784400
    - Not yet recruiting
    - Fundacao Pio Xii Hospital de Cancer de Barretos
  - Blumenau, Brazil, 89010-340
    - Not yet recruiting
    - Centro De Pesquisas Clinica Reichow
  - Curitiba, Brazil, 81520-060
    - Not yet recruiting
    - Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Cancer
  - Ijuí, Brazil, 98700-000
    - Not yet recruiting
    - Oncosite - Centro de Pesquisa Clinica e Oncologia
  - Itajaí, Brazil, 88301-220
    - Not yet recruiting
    - Clinica de Neoplasias Litoral Ltda
  - Lajeado, Brazil, 95900-000
    - Not yet recruiting
    - Hospital Bruno Born
  - Natal, Brazil, 59062-000
    - Not yet recruiting
    - Liga Norte-Rio-Grandense Contra o Cancer
  - Porto Alegre, Brazil, 90035-903
    - Not yet recruiting
    - Hospital de Clínicas de Porto Alegre
  - Porto Alegre, Brazil, 90020-090
    - Not yet recruiting
    - Irmandade Da Santa Casa de Misericórdia de Porto Alegre
  - Porto Alegre, Brazil, 90110-270
    - Not yet recruiting
    - Hgb - Hospital Giovanni Battista - Mae de Deus Center
  - Porto Alegre, Brazil, 90560032
    - Not yet recruiting
    - Hospital Moinhos de Vento
  - Ribeirão Preto, Brazil, 14051-140
    - Not yet recruiting
    - Hospital Das Clínicas Fmrp-Usp
  - SAO JOSE RIO Preto, Brazil, 15090-000
    - Not yet recruiting
    - Fundação Faculdade Regional de Medicina de São José do Rio Preto
  - Salvador, Brazil, 40170-110
    - Not yet recruiting
    - Nob - Nucleo de Oncologia Da Bahia
  - São Caetano do Sul, Brazil, 09541-270
    - Not yet recruiting
    - Ceon Pesquisas
  - São Paulo, Brazil, 01209-000
    - Not yet recruiting
    - Icavc - Instituto Do Câncer Arnaldo Vieira de Carvalho
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Not yet recruiting
    - Cross Cancer Institute
- Ontario
  - Hamilton, Ontario, Canada, L8V5C2
    - Not yet recruiting
    - Juravinski Cancer Clinic
  - Toronto, Ontario, Canada, M5G 2M9
    - Not yet recruiting
    - Princess Margaret Cancer Center
- Quebec
  - Lévis, Quebec, Canada, G6V 3Z1
    - Not yet recruiting
    - Hotel-Dieu de Levis
Denmark
- - Aalborg, Denmark, 09100
    - Not yet recruiting
    - Aalborg Universitetshospital
  - Copenhagen, Denmark, 02100
    - Withdrawn
    - Rigshospitalet
  - Odense C, Denmark, 05000
    - Not yet recruiting
    - OUH
  - Roskilde, Denmark, 04000
    - Not yet recruiting
    - Sjaellands Universitetshospital
  - Vejle, Denmark, 07100
    - Not yet recruiting
    - Sygehus Lillebælt - Vejle
France
- - Angers, France, 49055
    - Not yet recruiting
    - Institut de Cancérologie de l'Ouest
  - Bordeaux, France, 33076
    - Not yet recruiting
    - Chu Bordeaux-Hopital Pellegrin
  - Marseille, France, 13385
    - Not yet recruiting
    - Hôpital de la Timone
  - Marseille, France, 13273
    - Withdrawn
    - Institut Paoli Calmettes
  - Paris, France, 75015
    - Not yet recruiting
    - Hôpital Europeen Georges Pompidou
  - Paris, France, 75013
    - Not yet recruiting
    - Hospital Universitaire Pitie-Salpetriere
  - Poitiers, France, 86021
    - Not yet recruiting
    - Hospital de La Miletrie
  - Reims, France, 51100
    - Not yet recruiting
    - CHU de Reims
  - Saint-Etienne, France, 42055
    - Not yet recruiting
    - University hospital of Saint Etienne
  - Toulouse, France, 31059
    - Not yet recruiting
    - Chu Toulouse Hopital Rangueil
  - Villejuif, France, 94800
    - Not yet recruiting
    - Institut Gustave Roussy
Georgia
- - Batumi, Georgia, 06004
    - Not yet recruiting
    - High Technology Hospital Medcenter
  - Kutaisi, Georgia, 04600
    - Not yet recruiting
    - Jsc Evex Hospitals
  - Marneuli, Georgia, 03000
    - Not yet recruiting
    - Aversi Clinic Ltd
  - Tbilisi, Georgia, 00112
    - Not yet recruiting
    - Israel-Georgian Medical Research Clinic Helsicore
  - Tbilisi, Georgia, 00112
    - Not yet recruiting
    - Todua Clinic, Llc
  - Tbilisi, Georgia, 00144
    - Not yet recruiting
    - Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Llc
  - Tbilisi, Georgia, 00159
    - Not yet recruiting
    - Institute of Clinical Oncology Ltd
  - Tbilisi, Georgia, 00186
    - Not yet recruiting
    - Medulla Chemotherapy and Immunotherapy Clinic
  - Tbilisi, Georgia, 00159
    - Not yet recruiting
    - K. Eristavi National Center of Experimental and Clinical Surgery
  - Tbilisi, Georgia, 00186
    - Not yet recruiting
    - Caucasus Medical Centre Llc
Germany
- - Berlin, Germany, 13353
    - Not yet recruiting
    - Charite - Campus Virchow-Klinikum
  - Dresden, Germany, 01307
    - Not yet recruiting
    - University Hospital Carl Gustav Carus
  - Essen, Germany, 45147
    - Not yet recruiting
    - Universitaetsklinikum Essen
  - Frankfurt am Main, Germany, 60488
    - Not yet recruiting
    - Krankenhaus Nordwest GmbH
  - Freiburg im Breisgau, Germany, 79106
    - Not yet recruiting
    - University Medical Center Freiburg
  - Hamburg, Germany, 22763
    - Not yet recruiting
    - Asklepios Klinik Altona
  - Hamburg, Germany, 20246
    - Not yet recruiting
    - University Medical Centre Hamburg-Eppendorf Centre of Oncology
  - Hamburg, Germany, 20249
    - Withdrawn
    - Haematologisch-Onkologischen Praxis Eppendorf (Hope)
  - Hanover, Germany, 30625
    - Not yet recruiting
    - Hannover Medical School
  - Leipzig, Germany, 04103
    - Withdrawn
    - Universitaetsklinikum Leipzig Aoer
  - Lübeck, Germany, 23538
    - Not yet recruiting
    - Uksh Campus Lubeck
  - München, Germany, 81377
    - Not yet recruiting
    - Klinikum Der University Munchen - Campus Grosshadern
  - München, Germany, 81737
    - Not yet recruiting
    - Klinikum Neuperlach
  - Penzberg, Germany, 82377
    - Not yet recruiting
    - Roche Diagnostics Gmbh
  - Regensburg, Germany, 93053
    - Not yet recruiting
    - Universitaetsklinikum Regensburg
  - Ulm, Germany, 89081
    - Not yet recruiting
    - Universitatkinikums Ulm
Italy
- - Ancona, Italy, 60020
    - Not yet recruiting
    - Azienda Ospedaliero Universitaria delle Marche
  - Aviano, Italy, 33081
    - Not yet recruiting
    - IRCCS Centro di Riferimento Oncologico
  - Bari, Italy, 70124
    - Not yet recruiting
    - Istituto Tumori Giovanni Paolo II Irccs Ospedale Oncologico Bari
  - Brescia, Italy, 25124
    - Not yet recruiting
    - Fondazione Poliambulanza Istituto Ospedaliero
  - Candiolo, Italy, 10060
    - Not yet recruiting
    - Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia - Irccs
  - Catania, Italy, 95122
    - Not yet recruiting
    - Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
  - Milan, Italy, 20162
    - Not yet recruiting
    - ASST Grande Ospedale Metropolitano Niguarda
  - Milan, Italy, 20133
    - Not yet recruiting
    - Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
  - Naples, Italy, 80131
    - Not yet recruiting
    - Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
  - Padova, Italy, 35128
    - Not yet recruiting
    - Iov - Istituto Oncologico Veneto Irccs
  - Pisa, Italy, 56126
    - Not yet recruiting
    - Azienda Ospedaliero Universitaria Pisana
  - Ravenna, Italy, 48100
    - Not yet recruiting
    - Ospedale Santa Maria delle Croci
  - Reggio Emilia, Italy, 42121
    - Not yet recruiting
    - Arcispedale S. Maria Nuova Azienda Ospedaliera Di Reggio Emilia
  - Roma, Italy, 00152
    - Not yet recruiting
    - Azienda Ospedaliera San Camillo Forlanini
  - Rome, Italy, 00168
    - Withdrawn
    - Agostino Gemelli Policlinico Universitario
  - Rozzano, Italy, 20089
    - Not yet recruiting
    - IRCCS Istituto Clinico Humanitas
  - San Giovanni Rotondo, Italy, 71013
    - Not yet recruiting
    - I.R.C.C.S. Casa Sollievo Della Sofferenza
  - Verona, Italy, 37134
    - Not yet recruiting
    - Centro Ricerche Cliniche di Verona
Japan
- - Akashi-shi, Japan, 673-8558
    - Not yet recruiting
    - Hyogo Cancer Center
  - Chiba, Japan, 260-8717
    - Not yet recruiting
    - Chiba Cancer Center
  - Chūōku, Japan, 104-0045
    - Not yet recruiting
    - National Cancer Center Hospital
  - Fukuoka, Japan, 811-1395
    - Not yet recruiting
    - NHO Kyushu Cancer Center
  - Hidaka-shi, Japan, 350-1298
    - Recruiting
    - Saitama Medical University International Medical Center
  - Kashiwa-shi, Japan, 277-8577
    - Not yet recruiting
    - National Cancer Center Hospital East
  - Kawasaki-shi, Japan, 216-8511
    - Not yet recruiting
    - St. Marianna University Hospital
  - Kita-gun, Japan, 761-0793
    - Not yet recruiting
    - Kagawa University Hospital
  - Kobe, Japan, 650-0047
    - Not yet recruiting
    - Kobe City Hospital Organization Kobe City Medical Center General Hospital
  - Kōtoku, Japan, 135-8550
    - Recruiting
    - Cancer Institute Hospital of JFCR
  - Matsuyama, Japan, 791-0280
    - Not yet recruiting
    - Nho Shikoku Cancer Center
  - Nankoku-shi, Japan, 783-8505
    - Not yet recruiting
    - Kochi Medical School Hospital
  - Osaka, Japan, 541-8567
    - Not yet recruiting
    - Osaka International Cancer Institute
  - Suita-shi, Japan, 565-0871
    - Recruiting
    - The University of Osaka Hospital
  - Sunto-gun, Japan, 411-8777
    - Not yet recruiting
    - Shizuoka Cancer Center
  - Yokohama, Japan, 241-8515
    - Not yet recruiting
    - Kanagawa Cancer Center
Netherlands
- - Amersfoort, Netherlands, 3818 TZ
    - Not yet recruiting
    - Meander Medisch Centrum
  - Amsterdam, Netherlands, 1066 CX
    - Withdrawn
    - Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis
  - Amsterdam, Netherlands, 1081 HV
    - Withdrawn
    - Amsterdam UMC
  - Groningen, Netherlands, 9728 NT
    - Not yet recruiting
    - Martini Ziekenhuis
  - Maastricht, Netherlands, 6229 HX
    - Not yet recruiting
    - Maastricht UMC+
  - Rotterdam, Netherlands, 3015 GD
    - Not yet recruiting
    - Erasmus Medical Center
  - Utrecht, Netherlands, 3584 CX
    - Withdrawn
    - University Medical Center Utrecht
Norway
- - Bergen, Norway, 05021
    - Not yet recruiting
    - Haukeland Universitetssjukehus
  - Lørenskog, Norway, 01478
    - Not yet recruiting
    - Akershus Universitetssykehus HF
  - Oslo, Norway, 00405
    - Not yet recruiting
    - Utprovingsenheten, Oslo University Hospital Radiumhospitalet
  - Trondheim, Norway, 07030
    - Not yet recruiting
    - Universitetssykehuset I Trondheim - St. Olavs Hospital
Poland
- - Jelenia Góra, Poland, 58-506
    - Not yet recruiting
    - Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
  - Rzeszów, Poland, 35-055
    - Withdrawn
    - Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
  - Siedlce, Poland, 08-110
    - Not yet recruiting
    - Mazowiecki Szpital Wojewodzki Im. SW. Jana Pawla Ii W Siedlcach Sp Z O O
  - Warsaw, Poland, 01-748
    - Not yet recruiting
    - Luxmed Onkologia Sp. Z O.O.
  - Warsaw, Poland, 02-034
    - Not yet recruiting
    - Narodowy Instytut Onkologii Im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Puerto Rico
- - Dorado, Puerto Rico, 00646
    - Recruiting
    - Pan American Center For Oncology Trials Llc Dorado Office
South Korea
- - Changwon-si, South Korea, 51353
    - Not yet recruiting
    - Samsung Changwon Hospital
  - Goyang-si, South Korea, 10408
    - Not yet recruiting
    - National Cancer Center
  - Seongnam, South Korea, 13620
    - Not yet recruiting
    - Seoul National University Bundang Hospital
  - Seongnam-si, South Korea, 13496
    - Not yet recruiting
    - CHA Bundang Medical Center
  - Seoul, South Korea, 03312
    - Not yet recruiting
    - The Catholic University of Korea, Eunpyeong St. Mary's Hospital
  - Seoul, South Korea, 03080
    - Not yet recruiting
    - Seoul National University Hospital
  - Seoul, South Korea, 05505
    - Not yet recruiting
    - Asan Medical Center
  - Seoul, South Korea, 02841
    - Not yet recruiting
    - Korea University Anam Hospital
  - Seoul, South Korea, 03181
    - Not yet recruiting
    - Kangbuk Samsung Hospital
  - Seoul, South Korea, 04763
    - Not yet recruiting
    - Hanyang University Seoul Hospital
  - Seoul, South Korea, 06591
    - Not yet recruiting
    - The Catholic University of Korea Seoul St. Mary'S Hospital
  - Seoul, South Korea, 03722
    - Not yet recruiting
    - Severance Hospital Yonsei University Health System
  - Suwon, South Korea, 16499
    - Not yet recruiting
    - Ajou University Hospital
Spain
- - Badalona, Spain, 08916
    - Not yet recruiting
    - Hospital Universitari Germans Trias i Pujol
  - Barcelona, Spain, 08041
    - Not yet recruiting
    - Hospital De La Santa Creu I Sant Pau
  - Barcelona, Spain, 08035
    - Not yet recruiting
    - Hospital General Universitario Vall D Hebron
  - Barcelona, Spain, 08036
    - Not yet recruiting
    - Hospital Clinic Barcelona Main
  - Las Palmas de Gran Canaria, Spain, 35016
    - Not yet recruiting
    - Complejo Hospitalario Universitario Insular-Materno Infantil
  - Madrid, Spain, 28040
    - Not yet recruiting
    - Hospital Universitario Fundacion Jimenez Diaz
  - Madrid, Spain, 28041
    - Not yet recruiting
    - Hospital Universitario 12 de Octubre
  - Madrid, Spain, 28007
    - Not yet recruiting
    - Hospital General Universitario Gregorio Marañón
  - Majadahonda, Spain, 28220
    - Not yet recruiting
    - Hospital Universitario Puerta de Hierro de Majadahonda
  - Palma de Mallorca, Spain, 07120
    - Not yet recruiting
    - Son Espases University Hospital
  - Pamplona, Spain, 31008
    - Not yet recruiting
    - Hospital Universitario de Navarra
  - Santander, Spain, 39012
    - Not yet recruiting
    - Hospital Universitario Marqués de Valdecilla
  - Terrassa, Spain, 08221
    - Not yet recruiting
    - Hospital Universitari Mutua de Terrassa
  - Valencia, Spain, 46010
    - Not yet recruiting
    - Hospital Clinico Universitario de Valencia
  - Valencia, Spain, 46009
    - Not yet recruiting
    - Instituto Valenciano de Oncologia
  - Valencia, Spain, 46014
    - Withdrawn
    - Hospital General Universitario de Valencia
  - Zaragoza, Spain, 50009
    - Not yet recruiting
    - Hospital Universitario Miguel Servet
Switzerland
- - Bern, Switzerland, 03010
    - Not yet recruiting
    - Inselspital - Universitaetsspital Bern
  - Lausanne, Switzerland, 01005
    - Not yet recruiting
    - Chuv, Lausanne University Hospital
  - Sankt Gallen, Switzerland, 09007
    - Not yet recruiting
    - HOCH Health Ostschweiz
United Kingdom
- - Bristol, United Kingdom, BS2 8ED
    - Not yet recruiting
    - Bristol Haematology and Oncology centre
  - Cardiff, United Kingdom, CF14 2TL
    - Not yet recruiting
    - Velindre Cancer Centre
  - Leeds, United Kingdom, LS9 7TF
    - Not yet recruiting
    - St James University Hospital
  - London, United Kingdom, SE1 9RT
    - Not yet recruiting
    - Guys Hospital
  - London, United Kingdom, EC1A 7BE
    - Not yet recruiting
    - Barts Hospital
  - Maidstone, United Kingdom, ME16 9QQ
    - Not yet recruiting
    - Kent Oncology Centre - Maidstone Hospital
  - Manchester, United Kingdom, M20 4BX
    - Not yet recruiting
    - The Christie Nhs Foundation Trust Uk
  - Sutton, United Kingdom, SM2 5PT
    - Not yet recruiting
    - The Royal Marsden Nhs Foundation Trust - Sutton
United States
- Arizona
  - Chandler, Arizona, United States, 85224-5665
    - Withdrawn
    - Ironwood Cancer & Research Centers
  - Tucson, Arizona, United States, 85719
    - Not yet recruiting
    - The University of Arizona Cancer Center
  - Tucson, Arizona, United States, 85755
    - Recruiting
    - Roche Tissue Diagnostics, Companion Diagnostics
- California
  - Anaheim, California, United States, 92801
    - Not yet recruiting
    - Los Angeles Cancer Network
  - Cerritos, California, United States, 90703
    - Not yet recruiting
    - TOI Clinical Research
  - Fountain Valley, California, United States, 92708
    - Recruiting
    - Memorial Care Orange Coast Medical Center
  - Fullerton, California, United States, 92835
    - Not yet recruiting
    - Providence Medical Foundation
  - Los Angeles, California, United States, 90095
    - Not yet recruiting
    - University of California Los Angeles Health
- Colorado
  - Aurora, Colorado, United States, 80012
    - Recruiting
    - Sarah Cannon Research Institute Scri Oncology Partners
- Connecticut
  - Hartford, Connecticut, United States, 06102
    - Not yet recruiting
    - Hartford Hospital
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20037
    - Not yet recruiting
    - George Washington University
- Florida
  - Fort Myers, Florida, United States, 33912
    - Recruiting
    - Florida Oncology & Hematology
  - Gainesville, Florida, United States, 32610
    - Not yet recruiting
    - University of Florida Health
  - Miami, Florida, United States, 33136
    - Not yet recruiting
    - Sylvester Comprehensive Cancer Center
  - Orlando, Florida, United States, 32804
    - Not yet recruiting
    - Advent Health
  - Orlando, Florida, United States, 32806
    - Not yet recruiting
    - Orlando Health Cancer Institute Downtown Orlando
  - Pensacola, Florida, United States, 32504
    - Not yet recruiting
    - Ascension Sacred Heart Pensacola
  - Tampa, Florida, United States, 33606
    - Not yet recruiting
    - Tampa General Hospital-Cancer Institute
  - Tampa, Florida, United States, 33612-9497
    - Withdrawn
    - H. Lee Moffitt Cancer Center and Research Institute Hospital
- Georgia
  - Locust Grove, Georgia, United States, 30248
    - Not yet recruiting
    - Piedmont Cancer Institute
- Hawaii
  - Honolulu, Hawaii, United States, 96813-2402
    - Not yet recruiting
    - University of Hawaii Cancer Center
- Idaho
  - Boise, Idaho, United States, 83712
    - Not yet recruiting
    - St Lukes Mountain States Tumor Institute Msti Boise
- Illinois
  - Chicago, Illinois, United States, 60612
    - Not yet recruiting
    - University of Illinois Cancer Center
  - Evanston, Illinois, United States, 60201
    - Not yet recruiting
    - Endeavor Health
  - Springfield, Illinois, United States, 62702
    - Not yet recruiting
    - Springfield Clinic
- Indiana
  - Indianapolis, Indiana, United States, 46250
    - Recruiting
    - Community Health Network, Inc.
  - Indianapolis, Indiana, United States, 46202
    - Withdrawn
    - Iu Simon Cancer Center
  - Indianapolis, Indiana, United States, 46260
    - Not yet recruiting
    - Hematology Oncology of Indiana
- Iowa
  - Iowa City, Iowa, United States, 52242
    - Not yet recruiting
    - University of Iowa Hospital and Clinics
- Louisiana
  - New Orleans, Louisiana, United States, 70121
    - Withdrawn
    - Ochsner Clinic Foundation Ocf Ochsner Cancer Institute Oci
- Maryland
  - Baltimore, Maryland, United States, 21229-5201
    - Not yet recruiting
    - Saint Agnes Hospital
  - Bethesda, Maryland, United States, 20817
    - Recruiting
    - Cancer Center For Blood Disorders A Division of American Oncology Partners P.A
  - Brandywine, Maryland, United States, 20613
    - Recruiting
    - Sarah Cannon Research Institute Scri Oncology Partners
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Not yet recruiting
    - Massachusetts General Hospital
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Withdrawn
    - University of Michigan
  - Ann Arbor, Michigan, United States, 48197
    - Not yet recruiting
    - St. Joseph Mercy Hospital
  - Detroit, Michigan, United States, 48202
    - Not yet recruiting
    - Henry Ford Hospital
- Missouri
  - Columbia, Missouri, United States, 65201
    - Recruiting
    - Missouri Cancer Associates
  - Kansas City, Missouri, United States, 64111
    - Not yet recruiting
    - Saint Luke's Hospital of Kansas City
  - Kansas City, Missouri, United States, 64121
    - Recruiting
    - MidAmerica Cancer Care
  - Springfield, Missouri, United States, 65807
    - Recruiting
    - Oncology Hematology Associates
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - Washington University School of Medicine
- New Jersey
  - Morristown, New Jersey, United States, 07960
    - Not yet recruiting
    - Morristown Medical Center
- New Mexico
  - Rio Rancho, New Mexico, United States, 87124
    - Recruiting
    - Presbyterian Rust Medical Center
- New York
  - New Hyde Park, New York, United States, 11042
    - Withdrawn
    - Monter Cancer Center
  - New York, New York, United States, 10065
    - Not yet recruiting
    - Memorial Sloan Kettering Cancer Center
  - New York, New York, United States, 10019
    - Not yet recruiting
    - Icahn School of Medicine at Mount Sinai
  - Rochester, New York, United States, 14623-2327
    - Not yet recruiting
    - University of Rochester
  - Shirley, New York, United States, 11967
    - Not yet recruiting
    - Ny Cancer and Blood Specialists
  - The Bronx, New York, United States, 10461
    - Not yet recruiting
    - Montefiore Einstein For Cancer Care
- North Carolina
  - Asheville, North Carolina, United States, 28806
    - Recruiting
    - Messino Cancer Center
  - Chapel Hill, North Carolina, United States, 27514
    - Not yet recruiting
    - The University of North Carolina at Chapel Hill
  - Charlotte, North Carolina, United States, 28207
    - Not yet recruiting
    - Oncology Specialists of Charlotte
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Not yet recruiting
    - University of Cincinnati Cancer Institute
  - Columbus, Ohio, United States, 43214
    - Not yet recruiting
    - Ohio Health
  - Columbus, Ohio, United States, 43210
    - Not yet recruiting
    - Ohio State University-Arthur G James Comprehensive Cancer Center
- Pennsylvania
  - Bethlehem, Pennsylvania, United States, 18015
    - Not yet recruiting
    - St. Luke'S Health Network
  - Doylestown, Pennsylvania, United States, 18901
    - Recruiting
    - Alliance Cancer Specialists
  - Hershey, Pennsylvania, United States, 17033
    - Not yet recruiting
    - Penn State Milton S. Hershey Medical Center
  - Monroeville, Pennsylvania, United States, 15146
    - Not yet recruiting
    - Hillman Cancer Center
  - Philadelphia, Pennsylvania, United States, 19104
    - Not yet recruiting
    - University of Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19107
    - Withdrawn
    - Sidney Kimmel Comprehensive Cancer Center
  - Pittsburgh, Pennsylvania, United States, 15212
    - Not yet recruiting
    - Allegheny General Hospital Cancer Institute
  - York, Pennsylvania, United States, 17403
    - Recruiting
    - Cancer Care Associates of York
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Not yet recruiting
    - Avera Cancer Institute
- Tennessee
  - Knoxville, Tennessee, United States, 37909
    - Recruiting
    - Provision Center For Biomedical Research
  - Nashville, Tennessee, United States, 37203
    - Withdrawn
    - Tennessee Oncology, PLLC
  - Nashville, Tennessee, United States, 37203
    - Withdrawn
    - Sarah Cannon Research Institute Scri Oncology Partners
- Texas
  - Austin, Texas, United States, 78745
    - Recruiting
    - Texas Oncology
  - Austin, Texas, United States, 78712
    - Not yet recruiting
    - Ascension Seton Spclty Care Ctr
  - Dallas, Texas, United States, 75235
    - Not yet recruiting
    - University of Texas Southwestern Medical Center
  - Houston, Texas, United States, 77030
    - Not yet recruiting
    - MD Anderson Cancer Center
  - Temple, Texas, United States, 76508
    - Not yet recruiting
    - Baylor Scott & White Health
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - Not yet recruiting
    - University of Virginia Medical Center
  - Fairfax, Virginia, United States, 22031-4867
    - Withdrawn
    - Inova Schar Cancer Institute
  - Winchester, Virginia, United States, 22601
    - Recruiting
    - Shenandoah Oncology
- Washington
  - Seattle, Washington, United States, 98109
    - Withdrawn
    - Fred Hutchinson Cancer Center
  - Spokane, Washington, United States, 99202
    - Withdrawn
    - Cancer Care Northwest
- West Virginia
  - Charleston, West Virginia, United States, 25304
    - Not yet recruiting
    - Vandalia Health Charleston Area Medical Center
  - Morgantown, West Virginia, United States, 26506
    - Not yet recruiting
    - West Virginia University Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INCA33890 INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.	Drug: INCA33890 INCA33890 will be administered at protocol defined dose. Drug: Bevacizumab Bevacizumab will be administered at protocol defined dose. Drug: FOLFOX FOLFOX will be administered at protocol defined dose.
Placebo Comparator: Placebo Placebo will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.	Drug: Placebo Placebo will be administered at protocol defined dose. Drug: Bevacizumab Bevacizumab will be administered at protocol defined dose. Drug: FOLFOX FOLFOX will be administered at protocol defined dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) Time Frame: Up to 3 years	Defined as the time from the date of randomization to the date of the first documented progression as determined by the investigator per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 or death due to any cause.	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Time Frame: Up to 4 years	Defined as the time from the date of randomization to the date of death due to any cause.	Up to 4 years
Objective response Time Frame: Up to 3 years	Defined as complete response (CR) or partial response (PR) as determined by the investigator per RECIST v1.1.	Up to 3 years
Duration of Response (DOR) Time Frame: Up to 3 years	Defined as the time from the earliest date of documented response until the earliest date of disease progression as determined by the investigator per RECIST v1.1 or death due to any cause, whichever occurs first.	Up to 3 years
Treatment Emergent Adverse Events (TEAEs) Time Frame: Up to 4 years	Adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment, up to 90 days after the last dose INCA33890/placebo (or 30 days after the last dose of any FOLFOX component or bevacizumab if later) or the start of new anticancer therapy, whichever comes first.	Up to 4 years
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatmen Time Frame: Up to 4 years	TEAEs leading to dose interruption or study drug discontinuation.	Up to 4 years
Change from baseline in EQ-5D-5L score at protocol-defined visits Time Frame: Up to 4 years	The EQ-5D-5L is a validated, self-reported instrument for assessing HRQoL across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels of severity, ranging from no problems to extreme problems. The questionnaire also includes a visual analog scale for self-rated overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).	Up to 4 years
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at protocol-defined visits Time Frame: Up to 4 years	The EORTC QLQ-C30 is a validated, self-administered questionnaire developed to assess the quality of life in cancer patients. It consists of 30 questions divided into several subscales, including 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and a number of single-item measures that assess additional symptoms such as dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties.	Up to 4 years
Change from baseline in Functional Assessment of Cancer Therapy Colorectal Symptom Index (FCSI)-9 score at protocol-defined visits Time Frame: Up to 4 years	The FCSI-9 is a 9-item questionnaire derived from the FACT-C questionnaire to be a briefer, more targeted symptom-specific measure for patients with CRC. The FCSI-9 assesses common symptoms of CRC, including energy, pain, weight loss, nausea, diarrhea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The questionnaire is scored to produce a single total score, with a higher score indicating less symptoms.	Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

Study Director: Incyte Medical Monitor, Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2026

Primary Completion (Estimated)

December 29, 2028

Study Completion (Estimated)

September 28, 2029

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

INCA033890-303
2025-523735-19-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

IPD Sharing Time Frame

Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

IPD Sharing Access Criteria

Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on CRC (Colorectal Cancer)

Clinical Trials on INCA33890

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