CRC (Colorectal Cancer)Phase 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 Phase 3 study testing INCA33890, Bevacizumab and FOLFOX in people with CRC (Colorectal Cancer), run by Incyte Corporation at 297 sites in 22 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CRC (Colorectal Cancer)
- What is being tested?
- INCA33890, Bevacizumab and FOLFOX
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 297 sitesin 22 countries
- Study dates
- 5 Mar 2026to 28 Sep 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Significant concurrent and/or uncontrolled medical condition.
- History of organ transplant, including allogeneic stem cell transplantation.
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
297 sites in 22 countries. Contact the study team or a site near you to ask about taking part.
297 sites in 22 countries
United States78 sites, 78 recruiting
- Recruiting
Trinity Health St Joseph Mercy Ann Arbor
Ann Arbor, Michigan, 48197
- Recruiting
Thedacare Medical Oncology
Appleton, Wisconsin, 54911
- Recruiting
Messino Cancer Center
Asheville, North Carolina, 28806
- Recruiting
Sarah Cannon Research Institute Scri Oncology Partners
Aurora, Colorado, 80012
- Recruiting
Ascension Seton Spclty Care Ctr
Austin, Texas, 78712
- Recruiting
Texas Oncology
Austin, Texas, 78745
- Recruiting
Saint Agnes Hospital
Baltimore, Maryland, 21229-5201
- Recruiting
Cancer Center For Blood Disorders A Division of American Oncology Partners P.A
Bethesda, Maryland, 20817
- Not yet recruiting
St Lukes Mountain States Tumor Institute Msti Boise
Boise, Idaho, 83712
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Sarah Cannon Research Institute Scri Oncology Partners
Brandywine, Maryland, 20613
- Recruiting
Sih Cancer Institute
Carterville, Illinois, 62918
- Recruiting
The University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27514
- Not yet recruiting
Vandalia Health Charleston Area Medical Center
Charleston, West Virginia, 25304
- Recruiting
Oncology Specialists of Charlotte
Charlotte, North Carolina, 28210
- Not yet recruiting
University of Virginia Medical Center
Charlottesville, Virginia, 22908
- Recruiting
University of Illinois Cancer Center
Chicago, Illinois, 60612
- Recruiting
University of Cincinnati Cancer Institute
Cincinnati, Ohio, 45219
- Not yet recruiting
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
- Recruiting
Missouri Cancer Associates
Columbia, Missouri, 65201
- Recruiting
Ohio State University-Arthur G James Comprehensive Cancer Center
Columbus, Ohio, 43210
- Not yet recruiting
Ohio Health
Columbus, Ohio, 43214
- Not yet recruiting
Zangmeister Center
Columbus, Ohio, 43219
- Not yet recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
- Not yet recruiting
Total Health Center
Decatur, Georgia, 30034
- Not yet recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
- Recruiting
Alliance Cancer Specialists
Doylestown, Pennsylvania, 18901
- Not yet recruiting
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
- Recruiting
Endeavor Health
Evanston, Illinois, 60201
- Recruiting
Florida Oncology & Hematology
Fort Myers, Florida, 33912
- Recruiting
Memorial Care Orange Coast Medical Center
Fountain Valley, California, 92708
- Not yet recruiting
Mary Washington Healthcare
Fredericksburg, Virginia, 22405
- Recruiting
Hematology Oncology Associates of Fredericksburg Admin
Fredericksburg, Virginia, 22408
- Recruiting
Providence Medical Foundation
Fullerton, California, 92835
- Recruiting
University of Florida Health
Gainesville, Florida, 32610
- Not yet recruiting
Hartford Hospital
Hartford, Connecticut, 06102
- Not yet recruiting
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
- Not yet recruiting
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813-2402
- Recruiting
Md Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Community Health Network, Inc.
Indianapolis, Indiana, 46250
- Recruiting
Hematology Oncology of Indiana
Indianapolis, Indiana, 46260
- Not yet recruiting
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
- Recruiting
Saint Luke'S Hospital of Kansas City
Kansas City, Missouri, 64111
- Recruiting
Midamerica Cancer Care
Kansas City, Missouri, 64121
- Recruiting
Provision Center For Biomedical Research
Knoxville, Tennessee, 37909
- Recruiting
Piedmont Cancer Institute
Locust Grove, Georgia, 30248
- Recruiting
Cancer & Blood Research Center
Los Alamitos, California, 90720
- Not yet recruiting
University of California Los Angeles Health
Los Angeles, California, 90095
- Recruiting
Taylor Cancer Research Center
Maumee, Ohio, 43537
- Recruiting
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
- Not yet recruiting
Mitchell Cancer Institute
Mobile, Alabama, 36604
- Recruiting
West Virginia University Cancer Institute
Morgantown, West Virginia, 26506
- Recruiting
Morristown Medical Center
Morristown, New Jersey, 07960
- Not yet recruiting
Icahn School of Medicine At Mount Sinai
New York, New York, 10019
- Not yet recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Not yet recruiting
Vista Oncology Inc Ps
Olympia, Washington, 98506
- Not yet recruiting
Advent Health
Orlando, Florida, 32804
- Not yet recruiting
Orlando Health Cancer Institute Downtown Orlando
Orlando, Florida, 32806
- Recruiting
Ascension Sacred Heart Pensacola
Pensacola, Florida, 32504
- Not yet recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
Allegheny General Hospital Cancer Institute
Pittsburgh, Pennsylvania, 15212
- Recruiting
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
- Recruiting
Presbyterian Rust Medical Center
Rio Rancho, New Mexico, 87124
- Recruiting
Oncura Health
Sacramento, California, 94204
- Not yet recruiting
Virginia Mason Medical Center
Seattle, Washington, 98101
- Recruiting
Ny Cancer and Blood Specialists
Shirley, New York, 11967
- Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
- Recruiting
Springfield Clinic
Springfield, Illinois, 62703
- Recruiting
Oncology Hematology Associates
Springfield, Missouri, 65807
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
- Not yet recruiting
Tampa General Hospital-Cancer Institute
Tampa, Florida, 33606
- Not yet recruiting
Baylor Scott & White Health
Temple, Texas, 76508
- Not yet recruiting
Montefiore Medical Center
The Bronx, New York, 10461
- Recruiting
The University of Arizona Cancer Center
Tucson, Arizona, 85719
- Recruiting
Roche Tissue Diagnostics, Companion Diagnostics
Tucson, Arizona, 85755
- Not yet recruiting
George Washington University
Washington D.C., District of Columbia, 20037
- Recruiting
Shenandoah Oncology
Winchester, Virginia, 22601
- Recruiting
Cancer Care Associates of York
York, Pennsylvania, 17403
China29 sites, 29 recruiting
- Not yet recruiting
Peking University First Hospital
Beijing, 100034
- Not yet recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050
- Not yet recruiting
Xiangya Hospital Central South University
Changsha, 410013
- Not yet recruiting
Sichuan Cancer Hospital
Chengdu, 610041
- Not yet recruiting
Chongqing University Cancer Hospital
Chongqing, 400030
- Not yet recruiting
The First People'S Hospital of Foshan
Foshan, 528000
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, 350001
- Not yet recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, 510060
- Not yet recruiting
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, 510080
- Not yet recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, 510280
- Not yet recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou, 310009
- Not yet recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, 310009
- Not yet recruiting
University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
Hefei, 230001
- Not yet recruiting
Inner Mongolia People'S Hospital
Hohhot, 10017
- Not yet recruiting
Jinan Central Hospital
Jinan, 250013
- Not yet recruiting
Affiliated Hospital of Jining Medical University
Jining, 272029
- Not yet recruiting
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, 121001
- Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou, 730000
- Not yet recruiting
Meizhou Peoples Hospital
Meizhou, 514031
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, 330209
- Not yet recruiting
Guangxi Medical University Affiliated Tumor Hospital
Nanning, 530021
- Not yet recruiting
Zhongshan Hospital Fudan University
Shanghai, 200032
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200120
- Not yet recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, 50000
- Not yet recruiting
Tianjin Medical University Cancer Institute Hospital
Tianjin, 300060
- Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 00000
- Not yet recruiting
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430022
- Not yet recruiting
Hubei Cancer Hospital
Wuhan, 430079
- Not yet recruiting
Shaanxi Provincial People'S Hospital
Xi'an, 710068
Italy17 sites, 17 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Delle Marche
Ancona, 60020
- Not yet recruiting
Irccs Centro Di Riferimento Oncologico
Aviano, 33081
- Recruiting
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
Bari, 70124
- Recruiting
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, 25124
- Recruiting
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia - Irccs
Candiolo, 10060
- Not yet recruiting
Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
Catania, 95122
- Recruiting
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
Milan, 20133
- Recruiting
Asst Grande Ospedale Metropolitano Niguarda
Milan, 20162
- Recruiting
Azienda Ospedaliera Universitaria- Università Degli Studi Della Campania "Luigi Vanvitelli"
Naples, 80131
- Recruiting
Iov - Istituto Oncologico Veneto Irccs
Padova, 35128
- Recruiting
Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara
Pisa, 56126
- Recruiting
Ospedale Santa Maria Delle Croci
Ravenna, 48121
- Recruiting
Arcispedale S. Maria Nuova Azienda Ospedaliera Di Reggio Emilia
Reggio Emilia, 42121
- Recruiting
Azienda Ospedaliera San Camillo Forlanini
Roma, 00152
- Recruiting
Irccs Istituto Clinico Humanitas
Rozzano, 20089
- Recruiting
I.R.C.C.S. Casa Sollievo Della Sofferenza
San Giovanni Rotondo, 71013
- Recruiting
Centro Ricerche Cliniche Di Verona
Verona, 37134
Japan17 sites, 17 recruiting
- Recruiting
Hyogo Cancer Center
Akashi-shi, 673-8558
- Recruiting
Chiba Cancer Center
Chiba, 260-8717
- Not yet recruiting
National Cancer Center Hospital
Chūōku, 104-0045
- Recruiting
Nho Kyushu Cancer Center
Fukuoka, 811-1395
- Recruiting
Saitama Medical University International Medical Center
Hidaka-shi, 350-1298
- Recruiting
National Cancer Center Hospital East
Kashiwa-shi, 277-8577
- Not yet recruiting
St. Marianna University Hospital
Kawasaki-shi, 216-8511
- Recruiting
Kagawa University Hospital
Kita-gun, 761-0793
- Not yet recruiting
Saitama Cancer Center
Kitaadachi-gun, 362-0806
- Recruiting
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe, 650-0047
- Recruiting
Cancer Institute Hospital of Jfcr
Kōtoku, 135-8550
- Not yet recruiting
Kurashiki Central Hospital
Kurashiki-shi, 710-8602
- Recruiting
Kochi Medical School Hospital
Nankoku-shi, 783-8505
- Recruiting
Osaka International Cancer Institute
Osaka, 541-8567
- Recruiting
Shizuoka Cancer Center
Shizuoka, 411-8777
- Recruiting
The University of Osaka Hospital
Suita-shi, 565-0871
- Recruiting
Kanagawa Cancer Center
Yokohama, 241-8515
Spain17 sites, 17 recruiting
- Not yet recruiting
Hospital Universitari Germans Trias I Pujol
Badalona, 08916
- Not yet recruiting
Hospital General Universitario Vall D Hebron
Barcelona, 08035
- Not yet recruiting
Hospital Clinic Barcelona Main
Barcelona, 08036
- Not yet recruiting
Hospital de La Santa Creu I Sant Pau
Barcelona, 08041
- Not yet recruiting
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria, 35016
- Not yet recruiting
Hospital General Universitario Gregorio Maranon
Madrid, 28007
- Not yet recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
- Not yet recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Not yet recruiting
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, 28220
- Not yet recruiting
Son Espases University Hospital
Palma de Mallorca, 07120
- Not yet recruiting
Hospital Universitario de Navarra
Pamplona, 31008
- Not yet recruiting
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, 28223
- Not yet recruiting
Hospital Universitario Marques de Valdecilla
Santander, 39012
- Not yet recruiting
Hospital Universitari Mutua de Terrassa
Terrassa, 08221
- Not yet recruiting
Instituto Valenciano de Oncologia
Valencia, 46009
- Not yet recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
- Not yet recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
Brazil16 sites, 16 recruiting
- Not yet recruiting
Fundacao Pio Xii Hospital de Cancer de Barretos
Barretos, 14784400
- Recruiting
Centro de Pesquisas Clinica Reichow
Blumenau, 89010-340
- Not yet recruiting
Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Cancer
Curitiba, 81520-060
- Not yet recruiting
Oncosite - Centro de Pesquisa Clinica E Oncologia
Ijuí, 98700-500
- Recruiting
Clinica de Neoplasias Litoral Ltda
Itajaí, 88301-220
- Not yet recruiting
Hospital Bruno Born
Lajeado, 95900-000
- Recruiting
Liga Norte-Rio-Grandense Contra O Câncer
Natal, 59062-000
- Not yet recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, 90035-903
- Recruiting
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90050-170
- Recruiting
Hgb - Hospital Giovanni Battista - Mae de Deus Center
Porto Alegre, 90110-270
- Not yet recruiting
Hospital Moinhos de Vento
Porto Alegre, 90560032
- Not yet recruiting
Hospital Das Clínicas Fmrp-Usp
Ribeirão Preto, 14051-140
- Not yet recruiting
Nob - Nucleo de Oncologia Da Bahia
Salvador, 40170-110
- Recruiting
Ceon Pesquisas
São Caetano do Sul, 09541-270
- Recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
SAO JOSE RIO Preto, 15090-000
- Not yet recruiting
Icavc - Instituto Do Câncer Arnaldo Vieira de Carvalho
São Paulo, 01221-020
Australia15 sites, 15 recruiting
- Recruiting
Box Hill Hospital
Box Hill, Victoria, 03128
- Not yet recruiting
The Canberra Hospital
Canberra, 02605
- Recruiting
Austin Hospital
Heidelberg, Victoria, 03084
- Recruiting
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia, 05037
- Recruiting
Peter Maccallum Cancer Centre
Melbourne, Victoria, 03000
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 03004
- Recruiting
Fiona Stanley Hospital
Murdoch, 06150
- Recruiting
Port Macquarie Base Hospital
Port Macquarie, New South Wales, 02444
- Recruiting
Prince of Wales Hospital Au
Randwick, New South Wales, 02031
- Recruiting
Gold Coast University Hospital
Southport, Queensland, 04215
- Recruiting
Townsville Cancer Centre
Townsville, Queensland, 04814
- Recruiting
Calvary Mater Newcastle
Waratah, New South Wales, 02298
- Recruiting
Westmead Hospital
Westmead, New South Wales, 02046
- Recruiting
Wollongong Hospital
Wollongong, New South Wales, 02500
- Recruiting
Princess Alexandra Hospital Australia
Woolloongabba, Queensland, 04102
Georgia14 sites, 14 recruiting
- Recruiting
High Technology Hospital Medcenter
Batumi, 06004
- Recruiting
Jsc Evex Hospitals
Kutaisi, 04600
- Recruiting
Aversi Clinic Ltd
Marneuli, 03000
- Not yet recruiting
Archangel St. Michael Multi Profile Clinical Hospital
Tbilisi, 00102
- Recruiting
Israel-Georgian Medical Research Clinic Helsicore
Tbilisi, 00112
- Recruiting
Todua Clinic, Llc
Tbilisi, 00112
- Recruiting
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Llc
Tbilisi, 00144
- Recruiting
Institute of Clinical Oncology Ltd
Tbilisi, 00159
- Recruiting
K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, 00159
- Not yet recruiting
Tim-Tbilisi Institute of Medicine Ltd
Tbilisi, 00160
- Not yet recruiting
Cancer Research Center Ltd
Tbilisi, 00177
- Recruiting
Caucasus Medical Centre Llc
Tbilisi, 00186
- Not yet recruiting
Innova Llc
Tbilisi, 00186
- Recruiting
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi, 00186
Germany14 sites, 14 recruiting
- Recruiting
Charite - Campus Virchow-Klinikum
Berlin, 13353
- Not yet recruiting
University Hospital Carl Gustav Carus
Dresden, 01307
- Not yet recruiting
Universitaetsklinikum Essen
Essen, 45147
- Recruiting
Krankenhaus Nordwest Gmbh
Frankfurt am Main, 60488
- Not yet recruiting
University Medical Center Freiburg
Freiburg im Breisgau, 79106
- Recruiting
University Medical Centre Hamburg-Eppendorf Centre of Oncology
Hamburg, 20246
- Recruiting
Asklepios Klinik Altona
Hamburg, 22763
- Recruiting
Hannover Medical School
Hanover, 30625
- Not yet recruiting
Uksh Campus Lubeck
Lübeck, 23538
- Not yet recruiting
Klinikum Der University Munchen - Campus Grosshadern
München, 81377
- Recruiting
Klinikum Neuperlach
München, 81737
- Recruiting
Roche Diagnostics Gmbh
Penzberg, 82377
- Recruiting
Universitaetsklinikum Regensburg
Regensburg, 93053
- Not yet recruiting
Universitatkinikums Ulm
Ulm, 89081
South Korea14 sites, 14 recruiting
- Recruiting
Samsung Changwon Hospital
Changwon-si, 51353
- Recruiting
National Cancer Center
Goyang-si, 10408
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
- Recruiting
Cha Bundang Medical Center
Seongnam-si, 13496
- Recruiting
Korea University Anam Hospital
Seoul, 02841
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Kangbuk Samsung Hospital
Seoul, 03181
- Recruiting
The Catholic University of Korea, Eunpyeong St. Mary'S Hospital
Seoul, 03312
- Recruiting
Severance Hospital Yonsei University Health System
Seoul, 03722
- Recruiting
Hanyang University Seoul Hospital
Seoul, 04763
- Recruiting
Asan Medical Center
Seoul, 05505
- Not yet recruiting
Samsung Medical Center
Seoul, 06351
- Recruiting
The Catholic University of Korea Seoul St. Mary'S Hospital
Seoul, 06591
- Recruiting
Ajou University Hospital
Suwon, 16499
Argentina11 sites, 11 recruiting
- Not yet recruiting
Hospital Britanico de Buenos Aires
Buenos Aires, 01280
- Recruiting
Investigaciones Clinicas Moleculares Icm
Buenos Aires, 01425
- Not yet recruiting
Centro Medico Austral
Ciudad Autonoma Buenos Aires, 01019
- Not yet recruiting
Instituto Medico Especializado Alexander Fleming
Ciudad Autonoma Buenos Aires, 01426
- Not yet recruiting
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, C1199ABB
- Not yet recruiting
Instituto de Investigaciones Clinicas Cordoba S.A.
Córdoba, X5000AAW
- Not yet recruiting
Hospital Privado Centro Medico de Cordoba S.A
Córdoba, X5016KEH
- Recruiting
Centro Oncologico Riojano Integral (Cori)
La Rioja, 05300
- Not yet recruiting
Investigaciones Oncologicas C Colon
Mar del Plata, 07600
- Recruiting
Instituto de Oncologia de Rosario
Rosario, S2000KZE
- Not yet recruiting
Exelsus Srl
San Miguel de Tucumán, T4000IAN
United Kingdom9 sites, 9 recruiting
- Recruiting
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED
- Not yet recruiting
Velindre Cancer Centre
Cardiff, CF14 2TL
- Recruiting
St James University Hospital
Leeds, LS9 7TF
- Recruiting
Barts Hospital
London, EC1A 7BE
- Recruiting
Guys Hospital
London, SE1 9RT
- Recruiting
Royal Marsden Hospital - Fulham
London, SW3 6JJ
- Recruiting
Kent Oncology Centre - Maidstone Hospital
Maidstone, ME16 9QQ
- Recruiting
The Christie Nhs Foundation Trust Uk
Manchester, M20 4BX
- Recruiting
The Royal Marsden Nhs Foundation Trust - Sutton
Sutton, SM2 5PT
Canada8 sites, 8 recruiting
- Not yet recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
- Not yet recruiting
Cisss de La Monteregie Centre
Greenfield Park, Quebec, J4V 2H1
- Not yet recruiting
Juravinski Cancer Clinic
Hamilton, Ontario, L8V5C2
- Recruiting
Hotel-Dieu de Levis
Lévis, Quebec, G6V 3Z1
- Not yet recruiting
Unite de Recherche Clinique Cisss Des Laurentides
Saint-Jérôme, Quebec, J7Z 2V4
- Not yet recruiting
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
- Not yet recruiting
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
France8 sites, 8 recruiting
- Not yet recruiting
Institut de Cancerologie de L'Ouest
Angers, 49055
- Recruiting
Chu Bordeaux-Hopital Pellegrin
Bordeaux, 33076
- Recruiting
Hôpital de La Timone
Marseille, 13385
- Recruiting
Hospital Universitaire Pitie-Salpetriere
Paris, 75013
- Recruiting
Hospital de La Miletrie
Poitiers, 86021
- Recruiting
Chu de Reims
Reims, 51100
- Recruiting
University Hospital of Saint Etienne
Saint-Etienne, 42055
- Recruiting
Chu Toulouse Hopital Rangueil
Toulouse, 31059
Belgium7 sites, 7 recruiting
- Not yet recruiting
C.H.U. Brugmann - Site Victor Horta
Brussels, 01020
- Recruiting
Universitair Ziekenhuis Brussel
Brussels, 01090
- Recruiting
Cliniques Universitaires Ucl Saint-Luc
Brussels, 01200
- Recruiting
Universitair Ziekenhuis Antwerpen (Uza)
Edegem, 02650
- Recruiting
Universitair Ziekenhuis Gent (Uz Gent)
Ghent, 09000
- Recruiting
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven, 03000
- Recruiting
Chu Ucl Namur University Hospital Mont-Godinne
Yvoir, 05530
Denmark4 sites, 4 recruiting
- Recruiting
Aalborg Universitetshospital
Aalborg, 09100
- Recruiting
OUH
Odense C, 05000
- Not yet recruiting
Sjaellands Universitetshospital
Roskilde, 04000
- Recruiting
Sygehus Lillebælt - Vejle
Vejle, 07100
Netherlands4 sites, 4 recruiting
- Recruiting
Meander Medisch Centrum
Amersfoort, 3818 TZ
- Recruiting
Martini Ziekenhuis
Groningen, 9728 NT
- Recruiting
Maastricht Umc+
Maastricht, 6229 HX
- Not yet recruiting
Erasmus Medical Center
Rotterdam, 3015 GD
Norway4 sites, 4 recruiting
- Recruiting
Haukeland Universitetssjukehus
Bergen, 05021
- Recruiting
Akershus Universitetssykehus Hf
Lørenskog, 01478
- Recruiting
Utprovingsenheten, Oslo University Hospital Radiumhospitalet
Oslo, 00379
- Not yet recruiting
Universitetssykehuset I Trondheim - St. Olavs Hospital
Trondheim, 07030
Poland4 sites, 4 recruiting
- Not yet recruiting
Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
Jelenia Góra, 58-506
- Not yet recruiting
Mazowiecki Szpital Wojewodzki Im. SW. Jana Pawla Ii W Siedlcach Sp Z O O
Siedlce, 08-110
- Not yet recruiting
Luxmed Onkologia Sp. Z O.O.
Warsaw, 01-748
- Not yet recruiting
Narodowy Instytut Onkologii Im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, 02-034
Austria3 sites, 3 recruiting
- Recruiting
Lkh - Universitaetsklinikum Graz
Graz, 08036
- Recruiting
Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz
Linz, 04010
- Recruiting
Lkh - Universitatsklinikum Der Pmu Salzburg
Salzburg, 05020
Switzerland3 sites, 3 recruiting
- Not yet recruiting
Inselspital - Universitaetsspital Bern
Bern, 03010
- Not yet recruiting
Chuv, Lausanne University Hospital
Lausanne, 01005
- Not yet recruiting
Hoch Health Ostschweiz
Sankt Gallen, 09007
Puerto Rico1 site, 1 recruiting
- Recruiting
Pan American Center For Oncology Trials Llc Dorado Office
Dorado, 00646
About this study
Official title: 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.
- Conditions
- CRC (Colorectal Cancer)
- Being tested
- INCA33890, Placebo, Bevacizumab, FOLFOX
- Keywords
- Metastatic Colorectal Cancer, Colon Cancer, INCA33890
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCA33890Drug
INCA33890 will be administered at protocol defined dose.
PlaceboDrug
Placebo will be administered at protocol defined dose.
BevacizumabDrug
Bevacizumab will be administered at protocol defined dose.
FOLFOXDrug
FOLFOX will be administered at protocol defined dose.
| Study group | Role | What they receive |
|---|---|---|
| INCA33890 | Experimental | INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose. Receives: Drug: INCA33890; Drug: Bevacizumab; Drug: FOLFOX |
| Placebo | Placebo comparator | Placebo will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose. Receives: Drug: Placebo; Drug: Bevacizumab; Drug: FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
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.
Measured: Up to 3 years
Secondary outcomes (8)
Overall Survival (OS)
Defined as the time from the date of randomization to the date of death due to any cause.
Measured: Up to 4 years
Objective response
Defined as complete response (CR) or partial response (PR) as determined by the investigator per RECIST v1.1.
Measured: Up to 3 years
Duration of Response (DOR)
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.
Measured: Up to 3 years
Treatment Emergent Adverse Events (TEAEs)
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.
Measured: Up to 4 years
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatmen
TEAEs leading to dose interruption or study drug discontinuation.
Measured: Up to 4 years
Change from baseline in EQ-5D-5L score at protocol-defined visits
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).
Measured: 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
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.
Measured: Up to 4 years
Change from baseline in Functional Assessment of Cancer Therapy Colorectal Symptom Index (FCSI)-9 score at protocol-defined visits
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.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start5 Mar 2026
- Primary completion29 Dec 2028 (estimated)
- Study completion28 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRC (Colorectal Cancer)Studies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284849
- Sponsor's protocol ID
- INCA033890-303
- Other IDs
- 2025-523735-19-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 9 Dec 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07284849
- Acronym / sponsor ID
- INCA033890-303
- Conditions
- CRC (Colorectal Cancer)
- Keywords
- Metastatic Colorectal Cancer, Colon Cancer, INCA33890
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 29 Dec 2028 (estimated)
- Study completion
- 28 Sep 2029 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INCA33890 | Experimental | Drug: INCA33890, Drug: Bevacizumab, Drug: FOLFOXINCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Bevacizumab, Drug: FOLFOXPlacebo will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCA33890INCA33890 will be administered at protocol defined dose. | Drug | INCA33890 |
| PlaceboPlacebo will be administered at protocol defined dose. | Drug | Placebo |
| BevacizumabBevacizumab will be administered at protocol defined dose. | Drug | INCA33890, Placebo |
| FOLFOXFOLFOX will be administered at protocol defined dose. | Drug | INCA33890, Placebo |
Primary outcome
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.
8 secondary outcomes
Overall Survival (OS)
Time frame: Up to 4 years
Objective response
Time frame: Up to 3 years
Duration of Response (DOR)
Time frame: Up to 3 years
Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 4 years
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatmen
Time frame: Up to 4 years
Change from baseline in EQ-5D-5L score at protocol-defined visits
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- 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 CancerLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Incyte Medical Monitor study director
Incyte Corporation
297 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing INCA33890, Bevacizumab and FOLFOX in people with CRC (Colorectal Cancer), run by Incyte Corporation at 297 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 297 sites in United States, China, Italy, Japan, Spain and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Incyte Corporation Call Center (US) (1.855.463.3463, medinfo@incyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.