A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer
A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer
2 other identifiers
interventional
700
20 countries
254
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2026
Typical duration for phase_3
254 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2025
CompletedFirst Posted
Study publicly available on registry
December 16, 2025
CompletedStudy Start
First participant enrolled
March 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 28, 2029
April 16, 2026
April 1, 2026
2.8 years
December 9, 2025
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to 3 years
Secondary Outcomes (8)
Overall Survival (OS)
Up to 4 years
Objective response
Up to 3 years
Duration of Response (DOR)
Up to 3 years
Treatment Emergent Adverse Events (TEAEs)
Up to 4 years
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatmen
Up to 4 years
- +3 more secondary outcomes
Study Arms (2)
INCA33890
EXPERIMENTALINCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.
Placebo
PLACEBO COMPARATORPlacebo will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (272)
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224-5665, United States
The University of Arizona Cancer Center
Tucson, Arizona, 85719, United States
Roche Tissue Diagnostics, Companion Diagnostics
Tucson, Arizona, 85755, United States
Los Angeles Cancer Network
Anaheim, California, 92801, United States
Toi Clinical Research
Cerritos, California, 90703, United States
Providence Medical Foundation
Fullerton, California, 92835, United States
Long Beach Medical Center
Long Beach, California, 90806, 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
H. Lee Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida, 33612-9497, 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
University of Illinois Cancer Center
Chicago, Illinois, 60612, United States
Endeavor Health
Evanston, Illinois, 60201, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Iu Simon Cancer Center
Indianapolis, Indiana, 46202, 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
Ochsner Clinic Foundation Ocf Ochsner Cancer Institute Oci
New Orleans, Louisiana, 70121, United States
New England Cancer Specialists
Scarborough, Maine, 04074-7171, 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
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, 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 Healthcare Services
Albuquerque, New Mexico, 87113, United States
Monter Cancer Center
New Hyde Park, New York, 11042, United States
Icahn School of Medicine At Mount Sinai
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of Rochester
Rochester, New York, 14623-2327, 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
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, 17933, United States
Hillman Cancer Center
Monroeville, Pennsylvania, 15146, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Sidney Kimmel Comprehensive Cancer Center
Philadelphia, Pennsylvania, 19107, 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
Sarah Cannon Research Institute Scri Oncology Partners
Nashville, Tennessee, 37203, United States
Tennessee Oncology, Pllc
Nashville, Tennessee, 37203, 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
Inova Schar Cancer Institute
Fairfax, Virginia, 22031-4867, United States
Shenandoah Oncology
Winchester, Virginia, 22601, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Cancer Care Northwest
Spokane, Washington, 99202, 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
Hospital Britanico de Buenos Aires
Buenos Aires, 01280, Argentina
Investigaciones Clinicas Moleculares Icm
Buenos Aires, 01425, Argentina
Instituto Medico Especializado Alexander Fleming
Buenos Aires, C1426ANZ, Argentina
Centro Medico Austral
Ciudad Autonoma Buenos Aires, C1019ABS, 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, F5300COE, Argentina
Investigaciones Oncologicas C Colon
Mar del Plata, 07600, Argentina
Instituto de Oncologia de Rosario
Rosario, 02000, Argentina
Exelsus Srl
San Miguel de Tucumán, 04000, Argentina
Border Cancer Hospital Dispensary - Albury Wodonga Regional Cancer Centre
Albury, New South Wales, 02640, Australia
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
Flinders Medical Centre
Bedford Park, South Australia, 05042, 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
Akh - Medizinische Universität Wien
Vienna, 01090, Austria
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, 14784-400, 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, 14048-900, Brazil
Nob - Nucleo de Oncologia Da Bahia
Salvador, 40170110, Brazil
Ceon Pesquisas
Santo André, 09060-650, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
SAO JOSE RIO Preto, 15090-000, 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
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2R2, Canada
Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9, Canada
Hotel-Dieu de Levis
Lévis, Quebec, G6V 3Z1, Canada
McGill University Health Centre Research Institute
Montreal, Quebec, H4A 3J1, Canada
Aalborg Universitetshospital
Aalborg, 09100, Denmark
Rigshospitalet
Copenhagen, 02100, 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
Institut Paoli Calmettes
Marseille, 13273, 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-Etienne, 42055, 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
Haematologisch-Onkologischen Praxis Eppendorf (Hope)
Hamburg, 20249, Germany
Asklepios Klinik Altona
Hamburg, 22763, Germany
Hannover Medical School
Hanover, 30625, Germany
Universitaetsklinikum Leipzig Aoer
Leipzig, 04103, 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
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
Agostino Gemelli Policlinico Universitario
Rome, 00168, 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
Nho Shikoku Cancer Center
Matsuyama, 791-0280, Japan
Kochi Medical School Hospital
Nankoku-shi, 783-8505, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
The University of Osaka Hospital
Suita-shi, 565-0871, Japan
Shizuoka Cancer Center
Sunto-gun, 411-8777, Japan
Kanagawa Cancer Center
Yokohama, 241-8515, Japan
Meander Medisch Centrum
Amersfoort, 3818 TZ, Netherlands
Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, 1066 CX, Netherlands
Amsterdam Umc
Amsterdam, 1081 HV, Netherlands
Martini Ziekenhuis
Groningen, 9728 NT, Netherlands
Maastricht Umc+
Maastricht, 6229 HX, Netherlands
Erasmus Medical Center
Rotterdam, 3015 GD, Netherlands
University Medical Center Utrecht
Utrecht, 3584 CX, Netherlands
Haukeland Universitetssjukehus
Bergen, 05021, Norway
Akershus Universitetssykehus Hf
Lørenskog, 01478, Norway
Utprovingsenheten, Oslo University Hospital Radiumhospitalet
Oslo, 00405, Norway
Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
Jelenia Góra, 58-506, Poland
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
Rzeszów, 35-055, 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, 02-781, 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, 443-380, 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 Marques de Valdecilla
Santander, 39012, Spain
Hospital Universitari Mutua de Terrassa
Terrassa, 08221, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital General Universitario de Valencia
Valencia, 46014, 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
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Incyte Medical Monitor
Incyte Corporation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2025
First Posted
December 16, 2025
Study Start
March 5, 2026
Primary Completion (Estimated)
December 29, 2028
Study Completion (Estimated)
September 28, 2029
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
- 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.
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