Untreated, Unresectable, or Metastatic Colorectal CancerPhase 2/3NCT07221357
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer
A Phase 2/3 study testing Pumitamig, FOLFOX and FOLFIRI in people with Untreated, Unresectable, or Metastatic Colorectal Cancer, run by Bristol-Myers Squibb at 286 sites in 25 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or metastatic colorectal cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Untreated, Unresectable, or Metastatic Colorectal Cancer
- What is being tested?
- Pumitamig, FOLFOX and FOLFIRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 990 participants
- Where
- 286 sitesin 25 countries
- Study dates
- 31 Dec 2025to 11 Mar 2034
- Phase
- Phase 2/3
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
- Participant must previously untreated, histologically confirmed recurrent or metastatic colorectal adenocarcinoma, not amenable to curative surgery.
- Participant must have no known presence of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) per historical results (a validated test should be used).
- Participant must have no known presence of the gene that encodes the protein B-Raf (BRAF) V600E mutation per local testing.
- Participant must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Who cannot join
- Participant must not have any untreated known central nervous system (CNS) metastases including brain, leptomeningeal and/or spinal cord compression.
- Participant must not have any prior malignancy active within the previous 2 years, except for locally curable cancers that have been apparently cured and considered to be of low risk of recurrence.
- Participant must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, and/or ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
- Participant must not have prior systemic treatment with an anti-PD-1, anti-programmed death (ligand)-1 (PD-L1), anti-PD-L2, CD137 agonists, or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways or chemotherapy.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
286 sites in 25 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
286 sites in 25 countries
United States46 sites, 44 recruiting
- Recruiting
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Maged Khalil, Site 0348
- Not yet recruiting
Local Institution - 0430
Ann Arbor, Michigan, 48109
Site 0430
- Recruiting
Texas Oncology Dallas Fort Worth West (DFWW) - Arlington Cancer Center North
Arlington, Texas, 76012
Laith Abushahin, Site 0573
- Not yet recruiting
Local Institution - 0326
Atlanta, Georgia, 30318
Site 0326
- Recruiting
Northside Hospital
Atlanta, Georgia, 30342
Mary Ninan, Site 0276
- Recruiting
Texas Oncology, PA
Austin, Texas, 78705
Vivian Cline, Site 0571, 512-427-9400
- Not yet recruiting
Local Institution - 0262
Baltimore, Maryland, 21287
Site 0262
- Withdrawn
Local Institution - 0471
Boston, Massachusetts, 02114
- Recruiting
Florida Cancer Specialists - East
Cape Coral, Florida, 33990
Todd Gersten, Site 0574, 561-366-4100
- Not yet recruiting
Local Institution - 0290
Charlotte, North Carolina, 28207
Site 0290
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Ardaman Shergill, Site 0433, 773-702-6149
- Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Shafia Rahman, Site 0339, 614-293-3890
- Not yet recruiting
Local Institution - 0491
Edmonds, Washington, 98026-8032
Site 0491
- Not yet recruiting
Local Institution - 0278
Fairfax, Virginia, 22031
Site 0278
- Recruiting
Sanford Fargo Medical Center
Fargo, North Dakota, 58102
Jeffrey Wiisanen, Site 0526, 701-234-2358
- Not yet recruiting
Local Institution - 0638
Fort Wayne, Indiana, 46805
Site 0638
- Not yet recruiting
Local Institution - 0254
Grand Rapids, Michigan, 49546
Site 0254
- Recruiting
Baylor College of Medicine Medical Center
Houston, Texas, 77030
Shalini Makawita, Site 0252, 713-798-7710
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Saima Sharif, Site 0335, 319-353-7144
- Not yet recruiting
Local Institution - 0318
Kansas City, Missouri, 64111
Site 0318
- Recruiting
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, 11042
Nicholas Hornstein, Site 0429, 323-533-7275
- Recruiting
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Sandra Algaze, Site 0263, 818-406-8072
- Withdrawn
Local Institution - 0330
Los Angeles, California, 90404
- Recruiting
Minnesota Oncology
Maple Grove, Minnesota, 55369
Robert Delaune, Site 0572
- Recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060
Walid Shaib, Site 0369, 770-281-5124
- Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Mineola, New York, 11501
Rafael Winograd, Site 0270, 646-501-7802
- Not yet recruiting
Local Institution - 0333
Nashville, Tennessee, 37203
Site 0333
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Meredith Pelster, Site 0570, 615-986-4366
- Recruiting
Virginia Oncology Associates
Norfolk, Virginia, 23502
YUE ZHANG, Site 0577, 757-466-8683
- Recruiting
University Of Nebraska Medical Center
Omaha, Nebraska, 68198
Kelsey Klute, Site 0334, 701-471-0277
- Recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, 92868
Farshid Dayyani, Site 0345, 714-456-5153
- Not yet recruiting
Local Institution - 0604
Pittsburgh, Pennsylvania, 15232
Site 0604
- Not yet recruiting
Local Institution - 0426
Salt Lake City, Utah, 84102
Site 0426
- Recruiting
Texas Oncology - San Antonio
San Antonio, Texas, 78240
Sridhar Beeram, Site 0576, 210-615-1988
- Recruiting
California Pacific Medical Center - Pacific Campus
San Francisco, California, 94115
Ari Baron, Site 0317, 415-923-3012
- Not yet recruiting
Local Institution - 0253
Seattle, Washington, 98109
Site 0253
- Recruiting
New York Cancer and Blood Specialists
Shirley, New York, 11967
Richard Zuniga, Site 0273, 631-675-5075
- Recruiting
Maryland Oncology Hematology - Silver Spring
Silver Spring, Maryland, 20904
Danubia Hester, Site 0580
- Recruiting
Sanford Cancer Center
Sioux Falls, South Dakota, 57104
Jonathan Bleeker, Site 0312, 605-328-8000
- Not yet recruiting
Local Institution - 0629
Spokane, Washington, 99218
Site 0629
- Recruiting
Highlands Oncology Group
Springdale, Arkansas, 72762
Joseph Beck, Site 0432, 479-587-1700
- Recruiting
Washington University School OF Medicine-Siteman Cancer Center
St Louis, Missouri, 63110
Moh'd Khushman, Site 0336, 314-273-3564
- Recruiting
Florida Cancer Specialists - North
St. Petersburg, Florida, 33705
Maen Hussein, Site 0575, 727-216-1143
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Tiago Biachi de Castria, Site 0269, 646-673-0129
- Not yet recruiting
Local Institution - 0428
Tucson, Arizona, 85724
Site 0428
- Recruiting
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684
Spencer Shao, Site 0578, 503-528-5005
China30 sites, 28 recruiting
- Not yet recruiting
Local Institution - 0409
Beijing, 100034
Site 0409
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Wang Qi, Site 0376
- Not yet recruiting
Local Institution - 0411
Changsha, Hunan, 410031
Site 0411
- Recruiting
Sichuan Cancer hospital
Chengdu, Sichuan, 610041
Yongdong Jin, Site 0498, 028-85420384
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Jianghong Wang, Site 0499, 13983841209
- Not yet recruiting
Local Institution - 0354
Fuzhou, Fujian, 350014
Site 0354
- Recruiting
Fujian Medical University Union Hospital
Fuzhou Fujian, Fujian, 350001
Xiaoyan Lin, Site 0388, 8613950482366
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000
Jian Xiao, Site 0414
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ruihua Xu, Site 0130, 13922206676
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Yanhong Deng, Site 0358, 8613925106525
- Not yet recruiting
Local Institution - 0360
Hangzhou, Zhejiang, 310003
Site 0360
- Withdrawn
Local Institution - 0383
Hangzhou, Zhejiang, 310022
- Not yet recruiting
Local Institution - 0457
Hangzhou, 310009
Site 0457
- Not yet recruiting
Local Institution - 0353
Harbin, Heilongjiang, 150081
Site 0353
- Recruiting
Second Affiliated hospital of Anhui Medical University
Hefei, Anhui, 230000
Mingjun Zhang, Site 0595, 13865952007
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Changzheng Li, Site 0382
- Not yet recruiting
Local Institution - 0381
Nanchang, Jiangxi, 330006
Site 0381
- Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Yan Sun, Site 0416
- Recruiting
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530200
Yongqiang Li, Site 0379, 13457161928
- Recruiting
Nanyang City Center Hospital
Nanyang, Henan, 473009
Lixin Wan, Site 0384, +8613838708656
- Not yet recruiting
Local Institution - 0378
Shanghai, Shanghai Municipality, 200120
Site 0378
- Not yet recruiting
Local Institution - 0356
Shanghai, 200032
Site 0356
- Withdrawn
Local Institution - 0352
Shenyang, Liaoning, 110001
- Not yet recruiting
Local Institution - 0355
Shenyang, Liaoning, 110042
Site 0355
- Not yet recruiting
Local Institution - 0650
Shenzhen, Guangdong, 518020
Site 0650
- Recruiting
First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Yusheng Wang, Site 0393, 8613834646436
- Not yet recruiting
Local Institution - 0390
Tianjin, Hebei, 300060
Site 0390
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Hongli Liu, Site 0412, 13995680822
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Xinjun Liang, Site 0391, 8613995607152
- Recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001
Xianwen Zhang, Site 0398, 18051060926
Japan20 sites, 20 recruiting
- Recruiting
Chiba cancer center
Chiba, Chiba, 260-8717
Tadamichi Denda, Site 0053, 81432645431
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
Toshiharu Hirose, Site 0475, 81335422511
- Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Taito Esaki, Site 0052, 81925413231
- Recruiting
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298
Tetsuya Hamaguchi, Site 0046, 81429844111
- Recruiting
Saitama Prefectural Cancer Center
Ina-machi, Saitama, 362-0806
Hiroki Hara, Site 0597, 81487221111
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Akihito Kawazoe, Site 0493, 81471331111
- Recruiting
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
Hisateru Yasui, Site 0047, 078-302-4321
- Recruiting
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
Kensei Yamaguchi, Site 0044, 81335200111
- Recruiting
Kurashiki Central Hospital
Kurashiki, Okayama-ken, 710-8602
Shinichi Nishina, Site 0476, +81-86-422-0210
- Recruiting
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
Tomohiro Nishina, Site 0045, 81899991111
- Recruiting
Shizuoka Cancer Center
Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777
Kentaro Yamazaki, Site 0054, 81559895222
- Recruiting
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
Hiroya Taniguchi, Site 0473, 81527626111
- Recruiting
Osaka International Cancer Institute
Osaka, 541-8567
Toshihiro Kudo, Site 0506, 81669451181
- Recruiting
Hokkaido University Hospital
Sapporo, Hokkaido, 0608648
Yoshito Komatsu, Site 0051, 81117065657
- Recruiting
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Hisato Kawakami, Site 0067, 81723660221
- Recruiting
The University of Osaka Hospital
Suita, Osaka, 565-0871
Taroh Satoh, Site 0066, 81668795111
- Recruiting
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, 569-8686
Hiroyuki Kodama, Site 0521, 0000000000
- Recruiting
Fujita Health University
Toyoake, Aichi-ken, 470-1192
Hiroshi Matsuoka, Site 0641, +81-562-93-2139
- Recruiting
Yamagata University Hospital
Yamagata, 990-9585
Masanobu Takahashi, Site 0642, 0227178543
- Recruiting
Kanagawa cancer center
Yokohama, Kanagawa, 2418515
Hiroki Osumi, Site 0056, 81335700208
Germany16 sites, 16 recruiting
- Recruiting
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin, 10117
Arndt Stahler, Site 0035, 4989440073126
- Recruiting
St. Josef und St. Elisabeth Hospital gGmbH
Bochum, 44791
Anke Reinacher-Schick, Site 0061, +492345093780
- Recruiting
Klinikum Chemnitz Ggmbh
Chemnitz, 09113
Mathias Haenel, Site 0588, 4937133344500
- Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, 01307
Gunnar Folprecht, Site 0033, +493514584794
- Recruiting
Marien Hospital Düsseldorf
Düsseldorf, 40479
Aristoteles Giagounidis, Site 0057, 021144002079
- Recruiting
Universtiy Hospital of Erlangen
Erlangen, Bavaria, 91054
Clemens Neufert, Site 0591, +4991318535000
- Recruiting
Krankenhaus Nordwest GmbH
Frankfurt, 60488
Thorsten Goetze, Site 0040, 496976014187
- Recruiting
Universitaetsmedizin Goettingen
Göttingen, 37075
Alexander Koenig, Site 0058, +495513963879
- Recruiting
Facharztzentrum Eppendorf
Hamburg, 22297
Alexander Stein, Site 0039, 494036035220
- Recruiting
Asklepios Altona
Hamburg, 22763
Dirk Arnold, Site 0594, 49401818811211
- Recruiting
Praxis Onkologie am Raschplatz
Hanover, Lower Saxony, 30161
Eyck von der Heyde, Site 0607, 0177-6506614
- Recruiting
Universitatsklinikum Leipzig
Leipzig, D-04103
Benjamin Kobitzsch, Site 0041
- Recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, 55131
Markus Moehler, Site 0060, 496131176076
- Recruiting
Universitätsmedizin Mannheim
Mannheim, 68167
Ralf-Dieter Hofheinz, Site 0059, +496213832488
- Recruiting
Klinikum Neuperlach
München, 81737
Stefan Boeck, Site 0034
- Recruiting
Universitaetsklinikum Ulm
Ulm, 89081
Thomas Seufferlein, Site 0037, 4973150044500
Italy16 sites, 16 recruiting
- Not yet recruiting
Local Institution - 0609
Avellino, 83100
Site 0609
- Recruiting
Centro di Riferimento Oncologico
Aviano, Pordenone, 33081
Marco de Scordilli, Site 0614
- Recruiting
Instituto Tumori Giovanni Paolo II
Bari, 70124
Antonella Argentiero, Site 0610
- Not yet recruiting
Local Institution - 0617
Castellana Grotte, Bari, 70013
Site 0617
- Recruiting
Azienda Ospedaliera Garibaldi
Catania, 95124
Roberto Bordonaro, Site 0227, 390957595936
- Not yet recruiting
Local Institution - 0615
La Spezia, 19124
Site 0615
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano, 20162
Katia Bruna Bencardino, Site 0231, +390264444044
- Not yet recruiting
Local Institution - 0111
Milan, 20133
Site 0111
- Recruiting
Ospedale San Raffaele
Milan, 20132
Monica Ronzoni, Site 0213, +390226436523
- Recruiting
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, 80131
Antonio Avallone, Site 0236, 3407844709
- Recruiting
Istituto Oncologico Veneto IRCCS
Padova, Veneto, 35128
Sara Lonardi, Site 0221, 390498215910
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56126
Gianluca Masi, Site 0226, 39050992852
- Not yet recruiting
Local Institution - 0612
Ravenna, 48121
Site 0612
- Recruiting
Arcispedale Santa Maria Nuova
Reggio Emilia, 42123
Maria Banzi, Site 0233, +390522296858
- Recruiting
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013
Tiziana Latiano, Site 0584, 390882410709
- Recruiting
Pia Fondazione Di Culto E Di Religione Card. G. Panico
Tricase, Lecce, 73039
Emiliano Tamburini, Site 0619, 00390833773111
Australia15 sites, 15 recruiting
- Recruiting
Flinders Medical Centre
Adelaide, South Australia, 5042
Christos Karapetis, Site 0156, 61882048997
- Recruiting
Grampians Health
Ballarat Central, Victoria, 3350
Geoffrey Chong, Site 0196
- Recruiting
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
Michael Allen, Site 0274, +61752021111
- Recruiting
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Matthew Burge, Site 0215, 61736468111
- Recruiting
Gallipoli Medical Research Ltd
Brisbane, Queensland, 4120
Warren Joubert, Site 0191, +61 7 3394 7284
- Recruiting
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Kate Mahon, Site 0643, +61 2 8514 0311
- Recruiting
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112
Christopher Hocking, Site 0155, 0871177265
- Recruiting
Northern Hospital
Epping, Victoria, 3076
Belinda Lee, Site 0190, 0384058000
- Recruiting
Liverpool Hospital
Liverpool, New South Wales, 2170
Weng Ng, Site 0277, 61287389744
- Recruiting
Cabrini Hospital - Malvern
Malvern, Victoria, 3144
Shehara Mendis, Site 0160, (03)95083434
- Recruiting
St. John of God Murdoch Hospital
Murdoch, Western Australia, 6150
Kynan Feeney, Site 0154, +61894389599
- Recruiting
Goulburn Valley Health
Shepparton, Victoria, 3630
Arvind Sahu, Site 0194, 0436474996
- Recruiting
Western Health-Sunshine & Footscray Hospitals
St Albans, Victoria, 3021
Shehara Mendis, Site 0519, (03)95083434
- Recruiting
GenesisCare St Leonards
St Leonards, New South Wales, 2065
Connie Diakos, Site 0157, 61294631172
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Adnan Nagrial, Site 0159, 0288905200
France15 sites, 12 recruiting
- Withdrawn
Local Institution - 0590
Besançon, Doubs, 25000
- Active, not recruiting
Local Institution - 0138
Dijon, 21000
- Recruiting
Centre Oscar Lambret
Lille, Nord, 59020
Aurelien Carnot, Site 0613, +33320295920
- Recruiting
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
Limoges, 87042
Frederic Thuillier, Site 0616, 33555056396
- Recruiting
Groupe Hospitalier Bretagne Sud
Lorient, Morbihan, 56100
Edwina Girard, Site 0618
- Withdrawn
Local Institution - 0121
Marseille, Provence-Alpes-Côte d'Azur Region, 13273
- Recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Marseille, 13385
Laetitia Dahan, Site 0202, 33491388472
- Recruiting
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Pays de la Loire Region, 44093
Yann Touchefeu, Site 0125, 33240083163
- Recruiting
Hôpital Saint Antoine
Paris, 75571
Thierry Andre, Site 0183, 33149282954
- Recruiting
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine, 33600
Denis Smith, Site 0181, 33557656439
- Recruiting
CHU Charles Nicolle
Rouen, Haute-Normandie, 76031
Frederic Di Fiore, Site 0127, 33232888610
- Recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain, Loire-Atlantique, 44805
Amelie Mallet, Site 0182, 0240679900
- Recruiting
Hôpital Foch
Suresnes, Hauts-de-Seine, 92150
Jaafar Bennouna, Site 0634, 33240679993
- Recruiting
CHU Rangueil
Toulouse, Haute-Garonne, 31059
Nadim Fares, Site 0097, 33561322142
- Recruiting
Gustave Roussy
Villejuif, Val-de-Marne, 94800
Michel Ducreux, Site 0098, 33142114308
United Kingdom15 sites, 15 recruiting
- Recruiting
University Hospitals Birmingham
Birmingham, B15 2TH
Victoria Kunene, Site 0540, +441216272000
- Recruiting
Velindre Cancer Centre
Cardiff, CF14 2TL
Katie Wallace, Site 0601
- Recruiting
Dorset County Hospital
Dorchester, DT1 2JY
Amelie Harle, Site 0602, +441614468283
- Recruiting
Gartnavel General Hospital
Glasgow, G12 0YN
Janet Graham, Site 0307
- Recruiting
The Royal Surrey County Hospital NHS Foundation Trust
Guildford, South East, GU27XX
Sophie Otter, Site 0644
- Recruiting
Royal Free London NHS Foundation Trust
London, NW32QG
Nikos Diamantis, Site 0600, 442034655501
- Recruiting
Royal Marsden Hospital Sutton
London, SM2 5PT
Naureen Starling, Site 0596, 442086426011
- Recruiting
St. George's Hospital
London, SW170QT
Dimitra Repana, Site 0639, +442071882006
- Recruiting
Royal Marsden Hospital
London, SW3 6JJ
Naureen Starling, Site 0316, 442086426011
- Recruiting
Maidstone and Tunbridge Wells NHS Trust
Maidstone, ME16 9QQ
Mark Hill, Site 0368, +441622225041
- Recruiting
The Christie NHS Foundation Trust
Manchester, Lancashire, M20 4BX
Michael Braun, Site 0305
- Recruiting
Clatterbridge Hospital
Metropolitan Borough of Wirral, Merseyside, L63 4JY
Amir Montazeri, Site 0599
- Recruiting
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Michelle Cunnell, Site 0310
- Recruiting
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, East, NR47UY
Andrew Ho, Site 0640
- Recruiting
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, OX3 7LJ
Victoria Woodcock, Site 0366, +441865741841
Poland11 sites, 10 recruiting
- Recruiting
Podkarpacki Ośrodek Onkologiczny im. ks. Bronisława Markiewicza
Brzozów, Podkarpackie Voivodeship, 36-200
Joanna Kiszka, Site 0365, 4848508233225
- Recruiting
COPERNICUS PL, Wojewodzkie Centrum Onkologii
Gdansk, Pomeranian Voivodeship, 80-219
Joanna Wojcik-Tomaszewska, Site 0626, 48505993747
- Withdrawn
Local Institution - 0451
Gliwice, Silesian Voivodeship, 44-101
- Recruiting
Wojewódzkie Centrum Szpitalne Kotliny Jeleniogórskiej
Jelenia Góra, 58-506
Katarzyna Wozniak, Site 0452, 48502051990
- Not yet recruiting
Local Institution - 0361
Koszalin, West Pomeranian Voivodeship, 75-581
Site 0361
- Recruiting
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow, Lesser Poland Voivodeship, 31-826
Marek Jasiowka, Site 0364, +48668641133
- Recruiting
SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
Opole, Opole Voivodeship, 45-061
Barbara Radecka, Site 0362, 48502313767
- Recruiting
Luxmed Onkologia sp. z o. o.
Warsaw, Masovian Voivodeship, 01-748
Pawel Morawski, Site 0363, 48693100299
- Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, Masovian Voivodeship, 02-034
Lucjan Wyrwicz, Site 0203, 225709223
- Recruiting
Państwowy Instytut Medyczny MSWiA
Warsaw, Masovian Voivodeship, 02-507
Pawel Nurzynski, Site 0525, +48602210857
- Recruiting
Mazowiecki Szpital Onkologiczny
Wieliszew, Masovian Voivodeship, 05-135
Joanna Omyla-Staszewska, Site 0359, 48227661500
Spain11 sites, 10 recruiting
- Recruiting
Institut Català d'Oncologia (ICO) - Badalona
Badalona, 08916
Jose Manzano Mozo, Site 0163, 34934978924
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035
Iosune Baraibar Argota, Site 0240, 34934894158
- Recruiting
Hospital General Universitario De Elche
Elche, 03203
Elena Asensio Martinez, Site 0472, +34966616541
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, 28034
Maria Reyes Ferreiro Monteagudo, Site 0624, (+34)913368263
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, 28041
Maria Riesco Martinez, Site 0229, 34913908003
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Pilar Garcia Alfonso, Site 0228, 34914269394
- Recruiting
H.R.U Málaga - Hospital General
Málaga, 29011
Julia Alcaide García, Site 0232, +34951308129
- Recruiting
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31009
Ruth Vera García, Site 0225, 34848422576
- Recruiting
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
Maria del Rosario Vidal Tocino, Site 0625
- Withdrawn
Local Institution - 0593
Santiago de Compostela, A Coruña [La Coruña], 15706
- Recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
Maria Luisa Limon Miron, Site 0234, 955013068
Brazil9 sites, 9 recruiting
- Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14784400
Leticia Costa, Site 0266
- Recruiting
Centro Integrado de Oncologia de Curitiba
Curitiba, Paraná, 80810050
Karina Vianna, Site 0267, +554130242421
- Recruiting
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59062-000
Sulene Oliveira, Site 0331, 5584991191032
- Not yet recruiting
Local Institution - 0375
Porto Alegre, Rio Grande do Sul, 90035-903
Site 0375
- Recruiting
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610000
Caroline Albuquerque Moreira da Silva, Site 0342, 555133203039
- Recruiting
Instituto de Oncologia Saint Gallen
Santa Cruz do Sul, Rio Grande do Sul, 96830-180
Bianca Correa Tabajara Weiss, Site 0373, 5551991898942
- Recruiting
Faculdade de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000
Kathia Abdalla, Site 0264, +551733216638
- Not yet recruiting
Local Institution - 0268
São Paulo, 01246-000
Site 0268
- Not yet recruiting
Local Institution - 0341
São Paulo, 01308-060
Site 0341
South Korea9 sites, 9 recruiting
- Recruiting
Kyungpook National University Chilgok Hospital
Deagu, Taegu-Kwangyǒkshi, 41404
Jong Gwang Kim, Site 0636, 82-53-200-2623
- Recruiting
National Cancer Center
Goyang-si, Kyǒnggi-do, 10408
Moon Ki Choi, Site 0635, 821090977544
- Recruiting
Seoul National University Bundang Hospital
Seongnam, Gyeonggido, 13620
Keun-Wook Lee, Site 0406, 82317872034
- Recruiting
Korea University Anam Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 02841
Soohyeon Lee, Site 0637, 821099480263
- Recruiting
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03080
Sae-Won Han, Site 0404, 82-2-2072-0242
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], 03722
Sang Joon Shin, Site 0405, 82222288138
- Recruiting
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Jeong Eun Kim, Site 0492, 82230103945
- Recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351
Seung Tae Kim, Site 0394, 82234100297
- Recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 06591
Myung Ah Lee, Site 0395, 82222586044
Canada8 sites, 7 recruiting
- Not yet recruiting
Local Institution - 0550
Calgary, Alberta, T2N 5G2
Site 0550
- Not yet recruiting
Local Institution - 0260
Halifax, Nova Scotia, B3H 3A7
Site 0260
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
Francine Aubin, Site 0258, 5148908000
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Petr Kavan, Site 0423, 5143408222ext23460
- Not yet recruiting
Local Institution - 0255
Ottawa, Ontario, K1H 8L6
Site 0255
- Recruiting
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUS
Sherbrooke, Quebec, J1H 5N4
Frederic Lemay, Site 0261, 819-346-1110
- Withdrawn
Local Institution - 0424
Toronto, Ontario, M4N 3M5
- Not yet recruiting
Local Institution - 0421
Toronto, Ontario, M5G 2M9
Site 0421
Argentina7 sites, 7 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., C1199ABB
Maria Alicia Verzura, Site 0071, 54111555960279
- Recruiting
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
Buenos Aires, C1431FWO
Julieta Grasselli, Site 0172, 541158826679
- Recruiting
Hospital Británico de Buenos Aires
CABA, Buenos Aires, CP1280AEB
Luciana Bella Quero, Site 0073, 005491151558633
- Recruiting
Centro Médico Fleischer
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1414
Guillermo Mendez, Site 0174, +5491162691673
- Recruiting
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ
Juan Manuel O Connor, Site 0069, 5411322189001165
- Recruiting
Sanatorio Allende - Nueva Córdoba
Córdoba, X5000JHQ
Chong Hun Kim, Site 0630, 33370632403
- Recruiting
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
San Miguel de Tucumán, Tucumán Province, T4000IHE
Ruben Segovia, Site 0632, 5493815512093
Belgium7 sites, 6 recruiting
- Recruiting
Imelda General Hospital
Bonheiden, Antwerpen, 2820
Pieter-Jan Cuyle, Site 0622, +3215505169
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-Capitale, Région de, 1200
Marc Van den Eynde, Site 0179, +3227641041
- Not yet recruiting
Local Institution - 0118
Brussels, 1000
Site 0118
- Withdrawn
Local Institution - 0620
Charleroi, Hainaut, 6060
- Recruiting
Antwerp University Hospital
Edegem, Antwerpen, 2650
Hans Prenen, Site 0103, 038213646
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Gertjan Rasschaert, Site 0115, 003216343791
- Recruiting
AZ Delta vzw
Roeselare, West-Vlaanderen, 8800
Sofie De Meulder, Site 0122, 051237215
India7 sites, 5 recruiting
- Not yet recruiting
Local Institution - 0554
Delhi, 110029
Site 0554
- Not yet recruiting
Local Institution - 0036
Mumbai, Maharashtra, 400012
Site 0036
- Withdrawn
Local Institution - 0552
Mumbai, Maharashtra, 400036
- Not yet recruiting
Local Institution - 0010
Nashik, Dādra and Nagar Haveli and Damān and Diu, 422001
Site 0010
- Withdrawn
Local Institution - 0557
Puducherry, 605006
- Not yet recruiting
Local Institution - 0038
Pune, 411001
Site 0038
- Not yet recruiting
Local Institution - 0654
Thiruvananthapuram, Kerala, 695011
Site 0654
Romania7 sites, 7 recruiting
- Recruiting
Fundeni Clinical Institute
Bucharest, Bucharest, 022328
Adina Croitoru, Site 0100, 40722300252
- Recruiting
Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor
Cluj-Napoca, Cluj, 400162
Adrian Radu Vidra, Site 0282, +40724251696
- Recruiting
Institutul Oncologic Cluj
Cluj-Napoca, 400015
Tudor Ciuleanu, Site 0142, 40745646368
- Recruiting
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, 200542
Michael Schenker, Site 0189, 40727774974
- Recruiting
Amethyst Radiotherapy Center-Oncologie Medicala
Floresti/ Cluj, 407280
Andrei Ungureanu, Site 0139, 40742206212
- Recruiting
S.C. Centrul de Oncologie Euroclinic S.R.L.
Iași, 700106
Constantin Volovat, Site 0370, 40746110096
- Recruiting
Institutul Regional de Oncologie
Iași, 700483
Bogdan Gafton, Site 0143, 40766307558
Czechia6 sites, 5 recruiting
- Recruiting
Masarykuv onkologicky ustav
Brno, Brno-město, 656 53
Jiri Tomasek, Site 0180, 420543136309
- Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Stanislav John, Site 0188, 420495834647
- Not yet recruiting
Local Institution - 0467
Olomouc, 77520
Site 0467
- Withdrawn
Local Institution - 0489
Prague, Praha 10, 10034
- Recruiting
Fakultni nemocnice Motol a Homolka
Prague, Praha 5, 150 06
Zdenek Linke, Site 0248, +420224434702
- Recruiting
Vseobecna fakultni nemocnice v Praze
Prague, 128 08
Michal Vocka, Site 0461, +420224962219
Taiwan6 sites, 6 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Jaw Yuan Wang, Site 0289, +886-7-3122805
- Not yet recruiting
Local Institution - 0301
Kaohsiung Niao Sung Dist, Kaohsiung, 83301
Site 0301
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
Yu-Min Yeh, Site 0291, 886623535354559
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Kun-Huei Yeh, Site 0297, 886223123456X67514
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Ming-Huang Chen, Site 0300, 8862287121212573
- Recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Hung-Chih Hsu, Site 0449, 886332812002524
Austria5 sites, 4 recruiting
- Withdrawn
Local Institution - 0164
Feldkirch, 6800
- Recruiting
Krankenhaus Der Barmherzigen Schwestern Linz
Linz, 4010
Andreas Reichinger, Site 0078, 004376774216
- Recruiting
Universitaetsklinik Salzburg
Salzburg, 5020
Lukas Weiss, Site 0178, 435725557892
- Recruiting
Universitätsklinikum St. Pölten
Sankt Pölten, 3100
Martin Wiesholzer, Site 0176, 02742900422140
- Recruiting
Medizinische Universitaet Wien/AKH
Vienna, 1090
Gerald Prager, Site 0082, 014040044240
Netherlands5 sites
- Withdrawn
Local Institution - 0112
Amsterdam, North Holland, 1081 HV
- Withdrawn
Local Institution - 0173
Eindhoven, North Brabant, 5623 EJ
- Withdrawn
Local Institution - 0170
Groningen, 9713 GZ
- Withdrawn
Local Institution - 0216
Tilburg, 5022 GC
- Withdrawn
Local Institution - 0167
Utrecht, 3543 AZ
Turkey (Türkiye)5 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0020
Adana, 1370
Site 0020
- Not yet recruiting
Local Institution - 0065
Ankara, 06100
Site 0065
- Withdrawn
Local Institution - 0018
Erzurum, 25070
- Not yet recruiting
Local Institution - 0296
Istanbul, 34214
Site 0296
- Withdrawn
Local Institution - 0295
Kadiköy/Istanbul, 41380
Singapore4 sites, 4 recruiting
- Recruiting
Curie Oncology (Farrer)
Singapore, Central Singapore, 217562
Su Pin Choo, Site 0511, 6562595538
- Recruiting
National University Hospital
Singapore, 119074
Wei Peng Yong, Site 0147, 6567724670
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
Evelyn Wong, Site 0145, 64638088
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
jens samol, Site 0285, +6596786385
Chile3 sites, 3 recruiting
- Recruiting
Bradfordhill
Recoleta, Santiago Metropolitan, 8420391
Jaime Gonzalez, Site 0171
- Recruiting
Fundacion Oncologia Arturo Lopez Perez
Santiago, Santiago Metropolitan, 7500921
Rodrigo Uribe, Site 0463, 56228205766
- Not yet recruiting
Local Institution - 0175
Santiago, Santiago Metropolitan, 8320000
Site 0175
Mexico3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0653
Chihuahua City, 31207
Site 0653
- Not yet recruiting
Local Institution - 0655
Mexico City, Mexico City, 14080
Site 0655
- Not yet recruiting
Local Institution - 0559
Tlalpan, 14080
Site 0559
About this study
Official title: ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer
The purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or metastatic colorectal cancer
- Being tested
- Pumitamig, FOLFOX, FOLFIRI, Bevacizumab, CAPOX
- Keywords
- Metastatic Colorectal Cancer (mCRC)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PumitamigDrug
Also called BMS-986545, BNT327, PM8002
Specified dose on specified days
FOLFOXDrug
Specified dose on specified days
FOLFIRIDrug
Specified dose on specified days
BevacizumabDrug
Specified dose on specified days
CAPOXDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A1 | Experimental | Not described Receives: Drug: Pumitamig; Drug: FOLFOX; Drug: FOLFIRI |
| Arm A2 | Experimental | Not described Receives: Drug: Pumitamig; Drug: FOLFOX; Drug: FOLFIRI |
| Arm B | Other | Not described Receives: Drug: FOLFOX; Drug: FOLFIRI; Drug: Bevacizumab |
| Arm C | Experimental | Not described Receives: Drug: Pumitamig; Drug: FOLFOX; Drug: FOLFIRI; Drug: CAPOX |
| Arm D | Other | Not described Receives: Drug: FOLFOX; Drug: FOLFIRI; Drug: Bevacizumab; Drug: CAPOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Phase 2
Measured: Up to 5 years
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)
Phase 3
Measured: Up to 5 years
Overall Survival (OS)
Phase 3
Measured: Up to 5 years
Secondary outcomes (7)
PFS by RECIST v1.1 per investigator assessment
Phase 2
Measured: Up to 5 years
Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment
Phase 2
Measured: Up to 5 years
Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment
Phase 2
Measured: Up to 5 years
Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment
Phase 2
Measured: Up to 5 years
Recommended dose of Pumitamig for Phase 3
Phase 2
Measured: Up to 5 years
OR by RECIST v1.1 per BICR
Phase 3
Measured: Up to 5 years
DOR by RECIST v1.1 per BICR
Phase 3
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2025
- Study start31 Dec 2025
- Primary completion2 Feb 2030 (estimated)
- Study completion11 Mar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Untreated, Unresectable, or Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 990 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221357
- Sponsor's protocol ID
- CA266-0003
- Other IDs
- 2025-523224-45, U1111-1325-6505, 2025
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html