| Condition or Disease | Intervention/Treatment |
|---|---|
Untreated, Unresectable, or Metastatic Colorectal Cancer | Drug: PumitamigDrug: PumitamigDrug: FOLFOXDrug: PumitamigDrug: FOLFOX |
ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .
| Condition or Disease | Intervention/Treatment |
|---|---|
Untreated, Unresectable, or Metastatic Colorectal Cancer | Drug: PumitamigDrug: PumitamigDrug: FOLFOXDrug: PumitamigDrug: FOLFOX |
| Study Type | Interventional |
|---|---|
| Actual Enrollment | 990 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | Double |
| Primary Purpose | Treatment |
| 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 |
| Study Start Date | December 30, 2025 |
| Actual Primary Completion Date | 3yrs 8mos from now |
| Actual Study Completion Date | 7yrs 10mos from now |
| Group/Cohort | Intervention/Treatment |
|---|---|
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| Ages Eligible for Study | (Adult, Older Adult) |
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| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| Inclusion Criteria | Inclusion Criteria 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. |
| Exclusion Criteria | Inclusion Criteria 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. Exclusion Criteria 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. |
| Sponsors and Collaborators | Bristol-Myers Squibb |
|---|---|
| Locations | Local Institution - 0428 | Tucson Arizona, United States, 85724Local Institution - 0432 | Springdale Arkansas, United States, 72762Local Institution - 0447 | La Jolla California, United States, 92037USC/Norris Comprehensive Cancer Center | Los Angeles California, United States, 90033University of California, Irvine (UCI) Health - UC Irvine Medical Center | Orange California, United States, 92868Local Institution - 0317 | San Francisco California, United States, 94115Local Institution - 0330 | Santa Monica California, United States, 90404Local Institution - 0293 | Stanford California, United States, 94305Florida Cancer Specialists - East | Cape Coral Florida, United States, 33990Florida Cancer Specialists - North | St. Petersburg Florida, United States, 33705Moffitt Cancer Center | Tampa Florida, United States, 33612Local Institution - 0276 | Atlanta Georgia, United States, 30342Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital | Marietta Georgia, United States, 30060Local Institution - 0030 | Chicago Illinois, United States, 60611Local Institution - 0433 | Chicago Illinois, United States, 60637Local Institution - 0638 | Fort Wayne Indiana, United States, 46805Local Institution - 0335 | Iowa City Iowa, United States, 52242Local Institution - 0262 | Baltimore Maryland, United States, 21287Maryland Oncology Hematology - Silver Spring | Silver Spring Maryland, United States, 20904Local Institution - 0471 | Boston Massachusetts, United States, 02114Local Institution - 0430 | Ann Arbor Michigan, United States, 48109Local Institution - 0254 | Grand Rapids Michigan, United States, 49546Minnesota Oncology | Maple Grove Minnesota, United States, 55369Local Institution - 0318 | Kansas City Missouri, United States, 64111Washington University School OF Medicine-Siteman Cancer Center | St Louis Missouri, United States, 63110Local Institution - 0334 | Omaha Nebraska, United States, 68198Northwell Health/ RJ Zuckerberg Cancer Center | Lake Success New York, United States, 11042Local Institution - 0270 | Mineola New York, United States, 11501Local Institution - 0273 | New Hyde Park New York, United States, 11042Local Institution - 0290 | Charlotte North Carolina, United States, 28207Local Institution - 0526 | Fargo North Dakota, United States, 58102Local Institution - 0339 | Columbus Ohio, United States, 43210Local Institution - 0605 | Oklahoma City Oklahoma, United States, 73104Lehigh Valley Health Network | Allentown Pennsylvania, United States, 18103Local Institution - 0604 | Pittsburgh Pennsylvania, United States, 15232Sanford Cancer Center | Sioux Falls South Dakota, United States, 57104Local Institution - 0333 | Nashville Tennessee, United States, 37203SCRI Oncology Partners | Nashville Tennessee, United States, 37203Texas Oncology Dallas Fort Worth West (DFWW) - Arlington Cancer Center North | Arlington Texas, United States, 76012Texas Oncology, PA | Austin Texas, United States, 78705Local Institution - 0252 | Houston Texas, United States, 77030Texas Oncology - San Antonio | San Antonio Texas, United States, 78240Local Institution - 0426 | Salt Lake City Utah, United States, 84102Local Institution - 0278 | Fairfax Virginia, United States, 22031Virginia Oncology Associates | Norfolk Virginia, United States, 23502Local Institution - 0491 | Edmonds Washington, United States, 98026-8032Local Institution - 0253 | Seattle Washington, United States, 98109Local Institution - 0629 | Spokane Washington, United States, 99218Northwest Cancer Specialists, P.C. | Vancouver Washington, United States, 98684Hospital Británico de Buenos Aires | CABA Buenos Aires, Argentina, CP1280AEBInstituto Alexander Fleming | Ciudad Autónoma de Buenos Aires Buenos Aires, Argentina, C1426ANZLocal Institution - 0071 | ABB Buenos Aires F.D., Argentina, C1199ABBLocal Institution - 0632 | San Miguel de Tucumán Tucumán Province, Argentina, T4000IHELocal Institution - 0174 | Buenos Aires , Argentina, 1039Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) | Buenos Aires , Argentina, C1431FWOLocal Institution - 0630 | Córdoba , Argentina, X5000JHQLocal Institution - 0643 | Camperdown New South Wales, Australia, 2050Local Institution - 0277 | Liverpool New South Wales, Australia, 2170GenesisCare St Leonards | St Leonards New South Wales, Australia, 2065Sunshine Coast University Hospital | Birtinya Queensland, Australia, 4575Royal Brisbane and Women's Hospital | Brisbane Queensland, Australia, 4029Local Institution - 0191 | Woolloongabba Queensland, Australia, 4102Local Institution - 0156 | Adelaide South Australia, Australia, 5042Lyell McEwin Hospital | Elizabeth Vale South Australia, Australia, 5112Grampians Health | Ballarat Central Victoria, Australia, 3350Local Institution - 0190 | Epping Victoria, Australia, 3076Goulburn Valley Health | Shepparton Victoria, Australia, 3630Local Institution - 0519 | St Albans Victoria, Australia, 3021St. John of God Murdoch Hospital | Murdoch Western Australia, Australia, 6150Local Institution - 0160 | Malvern , Australia, 3144Local Institution - 0159 | Wentworthville , Australia, NSW2145Local Institution - 0164 | Feldkirch , Austria, 6800Krankenhaus Der Barmherzigen Schwestern Linz | Linz , Austria, 4010Universitaetsklinik Salzburg | Salzburg , Austria, 5020Local Institution - 0176 | Sankt Pölten , Austria, 3100Local Institution - 0082 | Vienna , Austria, A-1090Local Institution - 0622 | Bonheiden Antwerpen, Belgium, 2820Local Institution - 0103 | Edegem Antwerpen, Belgium, 2650Cliniques universitaires Saint-Luc | Brussels Bruxelles-Capitale, Région de, Belgium, 1200Local Institution - 0620 | Charleroi Hainaut, Belgium, 6060UZ Leuven | Leuven Vlaams-Brabant, Belgium, 3000AZ Delta vzw | Roeselare West-Vlaanderen, Belgium, 8800Local Institution - 0118 | Brussels , Belgium, 1000Local Institution - 0267 | Curitiba Paraná, Brazil, 81480-580Local Institution - 0331 | Natal/RN Rio Grande do Norte, Brazil, 59062-000Local Institution - 0375 | Porto Alegre Rio Grande do Sul, Brazil, 90035-903Local Institution - 0342 | Porto Alegre Rio Grande do Sul, Brazil, 91610-000Local Institution - 0373 | Santa Cruz do Sul Rio Grande do Sul, Brazil, 96810-110Local Institution - 0444 | Chapecó Santa Catarina, Brazil, 89812-211Local Institution - 0266 | Barretos São Paulo, Brazil, 14784400Local Institution - 0264 | São José do Rio Preto , Brazil, 15090-000Local Institution - 0268 | São Paulo , Brazil, 01246-000Local Institution - 0341 | São Paulo , Brazil, 01308-060Local Institution - 0550 | Calgary Alberta, Canada, T2N 5G2Local Institution - 0260 | Halifax Nova Scotia, Canada, B3H 3A7Local Institution - 0255 | Ottawa Ontario, Canada, K1H 8L6Local Institution - 0424 | Toronto Ontario, Canada, M4N 3M5Local Institution - 0421 | Toronto Ontario, Canada, M5G 2M9Centre Hospitalier de l'Université de Montréal | Montreal Quebec, Canada, H2X 3E4Jewish General Hospital | Montreal Quebec, Canada, H3T 1E2Local Institution - 0261 | Sherbrooke Quebec, Canada, J1H 5N4Local Institution - 0171 | Recoleta Santiago Metropolitan, Chile, 8420391Local Institution - 0463 | Santiago Santiago Metropolitan, Chile, 7500921Local Institution - 0175 | Santiago Santiago Metropolitan, Chile, 7620002Local Institution - 0595 | Hefei Anhui, China, 230601Local Institution - 0499 | Chongqing Chongqing Municipality, China, 400030Local Institution - 0354 | Fuzhou Fujian, China, 350014Local Institution - 0388 | Fuzhou Fujian Fujian, China, 350001Local Institution - 0414 | Guangzhou Guangdong, China, 510000Local Institution - 0130 | Guangzhou Guangdong, China, 510555Local Institution - 0390 | Tianjin Hebei, China, 300060Local Institution - 0353 | Harbin Heilongjiang, China, 150081Local Institution - 0384 | Nanyang Henan, China, 473009Local Institution - 0391 | Wuhan Hubei, China, 430079Local Institution - 0376 | Changsha Hunan, China, 410013Local Institution - 0411 | Changsha Hunan, China, 410031Local Institution - 0398 | Yangzhou Jiangsu, China, 225001Local Institution - 0381 | Nanchang Jiangxi, China, 330006Local Institution - 0352 | Shenyang Liaoning, China, 110001Local Institution - 0355 | Shenyang Liaoning, China, 110042Local Institution - 0382 | Jinan Shandong, China, 250117Local Institution - 0378 | Shanghai Shanghai Municipality, China, 200120Local Institution - 0498 | Chengdu Sichuan, China, 610041Local Institution - 0360 | Hangzhou Zhejiang, China, 310003Local Institution - 0383 | Hangzhou Zhejiang, China, 310022Local Institution - 0409 | Beijing , China, 100034Local Institution - 0457 | Hangzhou , China, 310009Local Institution - 0416 | Nanjing, Jiangsu , China, 210009Local Institution - 0356 | Shanghai , China, 200032Local Institution - 0412 | Wuhan , China, 430022Local Institution - 0489 | Prague Praha 10, Czechia, 10034Local Institution - 0248 | Prague Praha 5, Czechia, 150 06Local Institution - 0461 | Prague Praha, Hlavní Mesto, Czechia, 12808Local Institution - 0180 | Brno , Czechia, 656 53Local Institution - 0188 | Hradec Králové , Czechia, 500 05Local Institution - 0467 | Olomouc , Czechia, 77520CHU Bordeaux Haut-Leveque | Pessac Aquitaine, France, 33600Local Institution - 0590 | Besançon Doubs, France, 25000CHU Rangueil | Toulouse Haute-Garonne, France, 31059CHU Charles Nicolle | Rouen Haute-Normandie, France, 76031Local Institution - 0182 | Saint-Herblain Loire-Atlantique, France, 44805Local Institution - 0618 | Lorient Morbihan, France, 56100Local Institution - 0613 | Lille Nord, France, 59020Local Institution - 0125 | Nantes Pays de la Loire Region, France, 44093Local Institution - 0121 | Marseille Provence-Alpes-Côte d'Azur Region, France, 13273Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand | Dijon , France, 21000Local Institution - 0616 | Limoges , France, 87042Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone | Marseille , France, 13385Hôpital Saint Antoine | Paris , France, 75571Local Institution - 0634 | Suresnes , France, 92151Local Institution - 0098 | Villejuif , France, 94805Local Institution - 0591 | Erlangen Bavaria, Germany, 91054Local Institution - 0607 | Hanover Lower Saxony, Germany, 30161Universitaetsklinikum Carl Gustav Carus Dresden | Dresden Saxony, Germany, 01307Local Institution - 0035 | Berlin , Germany, 10117Local Institution - 0061 | Bochum , Germany, 44791Local Institution - 0588 | Chemnitz , Germany, 09113Marien Hospital Düsseldorf | Düsseldorf , Germany, 40479Krankenhaus Nordwest GmbH | Frankfurt , Germany, 60488Universitaetsmedizin Goettingen | Göttingen , Germany, 37075Facharztzentrum Eppendorf | Hamburg , Germany, 20249Local Institution - 0594 | Hamburg , Germany, 22763Universitatsklinikum Leipzig | Leipzig , Germany, D-04103Local Institution - 0060 | Mainz , Germany, 55131Local Institution - 0059 | Mannheim , Germany, 68167Klinikum Neuperlach | München , Germany, 81737Local Institution - 0037 | Ulm , Germany, 89081Local Institution - 0203 | Veszprém , Hungary, 8200Local Institution - 0010 | Nashik Dādra and Nagar Haveli and Damān and Diu, India, 422001Local Institution - 0036 | Mumbai Maharashtra, India, 400012Local Institution - 0552 | Mumbai Maharashtra, India, 400036Local Institution - 0006 | Delhi , India, 110029Local Institution - 0554 | Delhi , India, 110029Local Institution - 0557 | Puducherry , India, 605006Local Institution - 0038 | Pune , India, 411001Local Institution - 0617 | Castellana Grotte Bari, Italy, 70013IRCCS Casa Sollievo della Sofferenza | San Giovanni Rotondo Foggia, Italy, 71013Local Institution - 0619 | Tricase Lecce, Italy, 73039ASST Grande Ospedale Metropolitano Niguarda | Milan Milano, Italy, 20162Local Institution - 0614 | Aviano Pordenone, Italy, 33081Azienda Ospedaliero Universitaria Pisana | Pisa Tuscany, Italy, 56126Istituto Oncologico Veneto IRCCS | Padova Veneto, Italy, 35128Local Institution - 0609 | Avellino , Italy, 83100Local Institution - 0610 | Bari , Italy, 70124Local Institution - 0227 | Catania , Italy, 95124Local Institution - 0615 | La Spezia , Italy, 19124Local Institution - 0111 | Milan , Italy, 20133Ospedale San Raffaele | Milan , Italy, 20132Istituto Nazionale Tumori IRCCS Fondazione Pascale | Naples , Italy, 80131Local Institution - 0612 | Ravenna , Italy, 48121Local Institution - 0233 | Reggio Emilia , Italy, 42123Local Institution - 0641 | Toyoake Aichi-ken, Japan, 470-1192Local Institution - 0053 | Chiba Chiba, Japan, 260-8717National Cancer Center Hospital East | Kashiwa Chiba, Japan, 277-8577Local Institution - 0045 | Matsuyama Ehime, Japan, 791-0280Hokkaido University Hospital | Sapporo Hokkaido, Japan, 0608648Local Institution - 0047 | Kobe Hyōgo, Japan, 6500047Local Institution - 0056 | Yokohama Kanagawa, Japan, 2418515Local Institution - 0476 | Kurashiki Okayama-ken, Japan, 710-8602The University of Osaka Hospital | Suita Osaka, Japan, 565-0871Local Institution - 0521 | Takatsuki Osaka, Japan, 569-8686Local Institution - 0046 | Hidaka Saitama, Japan, 350-1298National Cancer Center Hospital | Chuo-ku Tokyo, Japan, 104-0045The Cancer Institute Hospital of JFCR | Koto-ku Tokyo, Japan, 135-8550Local Institution - 0642 | Yamagata Yamagata, Japan, 990-9585Local Institution - 0473 | Chikusa-ku , Japan, 464-8681National Hospital Organization Kyushu Cancer Center | Fukuoka , Japan, 811-1395Local Institution - 0597 | Kitaadachi-gun , Japan, 362-0806Local Institution - 0506 | Osaka , Japan, 541-8567Local Institution - 0067 | Sendai , Japan, 980-8574Local Institution - 0054 | Sunto-gun , Japan, 411-8777Local Institution - 0173 | Eindhoven North Brabant, Netherlands, 5623 EJLocal Institution - 0112 | Amsterdam North Holland, Netherlands, 1105 AZLocal Institution - 0170 | Groningen , Netherlands, 9713 GZLocal Institution - 0216 | Tilburg , Netherlands, 5022 GCLocal Institution - 0167 | Utrecht , Netherlands, 3543 AZLocal Institution - 0364 | Krakow Lesser Poland Voivodeship, Poland, 31-826Local Institution - 0452 | Jelenia Góra Lower Silesian Voivodeship, Poland, 58-506Luxmed Onkologia sp. z o. o. | Warsaw Masovian Voivodeship, Poland, 01-748Local Institution - 0525 | Warsaw Masovian Voivodeship, Poland, 02-507Local Institution - 0359 | Warsaw Masovian Voivodeship, Poland, 03-411Local Institution - 0365 | Brzozów Podkarpackie Voivodeship, Poland, 36-200Local Institution - 0626 | Gdansk Pomeranian Voivodeship, Poland, 80-219Local Institution - 0451 | Gliwice Silesian Voivodeship, Poland, 44-101Local Institution - 0361 | Koszalin West Pomeranian Voivodeship, Poland, 75-581Local Institution - 0362 | Opole , Poland, 45-372Fundeni Clinical Institute | Bucharest Bucharest, Romania, 022328Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor | Cluj-Napoca Cluj, Romania, 400162Centrul de Oncologie "Sfântul Nectarie" | Craiova Dolj, Romania, 200542Institutul Oncologic Cluj | Cluj-Napoca , Romania, 400015Local Institution - 0139 | Floresti/ Cluj , Romania, 407280S.C. Centrul de Oncologie Euroclinic S.R.L. | Iași , Romania, 700106Institutul Regional de Oncologie | Iași , Romania, 700483National Cancer Centre Singapore | Singapore Central Singapore, Singapore, 168583Local Institution - 0147 | Singapore , Singapore, 119074Local Institution - 0285 | Singapore , Singapore, 308442Local Institution - 0511 | Singapore , Singapore, 329563Seoul National University Bundang Hospital | Seongnam Gyeonggido, South Korea, 13620Seoul National University Hospital | Seoul Seoul-teukbyeolsi [Seoul], South Korea, 03080Asan Medical Center | Seoul Seoul-teukbyeolsi [Seoul], South Korea, 05505Samsung Medical Center | Seoul Seoul-teukbyeolsi [Seoul], South Korea, 06351The Catholic Univ. of Korea Seoul St. Mary's Hospital | Seoul Seoul-teukbyeolsi [Seoul], South Korea, 06591Local Institution - 0405 | Seoul , South Korea, 120-752Local Institution - 0163 | Badalona Barcelona [Barcelona], Spain, 08916Local Institution - 0240 | Barcelona Barcelona [Barcelona], Spain, 08035Local Institution - 0624 | Madrid Madrid, Comunidad de, Spain, 28034Local Institution - 0229 | Madrid Madrid, Comunidad de, Spain, 28041Complejo Hospitalario de Navarra | Pamplona Navarre, Spain, 31009Local Institution - 0472 | Elche (alicante) , Spain, 03203Hospital General Universitario Gregorio Marañon | Madrid , Spain, 28007H.R.U Málaga - Hospital General | Málaga , Spain, 29011Local Institution - 0625 | Salamanca , Spain, 37007Local Institution - 0593 | Santiago de Compostela , Spain, 15706Hospital Universitario Virgen Del Rocio | Seville , Spain, 41013Local Institution - 0074 | Stockholm Stockholm County, Sweden, 17176Local Institution - 0185 | Gothenburg Västra Götaland County, Sweden, 41685Local Institution - 0400 | Lund , Sweden, 22184Local Institution - 0301 | Kaohsiung Niao Sung Dist Kaohsiung, Taiwan, 83301Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City , Taiwan, 807National Cheng Kung University Hospital | Tainan , Taiwan, 704National Taiwan University Hospital | Taipei , Taiwan, 10002Local Institution - 0300 | Taipei , Taiwan, 11217Chang Gung Medical Foundation-Linkou Branch | Taoyuan , Taiwan, 333Local Institution - 0020 | Adana , Turkey (Türkiye), 1370Local Institution - 0065 | Ankara , Turkey (Türkiye), 06100Local Institution - 0018 | Erzurum , Turkey (Türkiye), 25070Local Institution - 0296 | Istanbul , Turkey (Türkiye), 34214Local Institution - 0295 | Kadiköy/Istanbul , Turkey (Türkiye), 41380The Christie NHS Foundation Trust | Manchester Lancashire, United Kingdom, M20 4BXLocal Institution - 0600 | Enfield London, United Kingdom, EN28JLLocal Institution - 0366 | Oxford Oxfordshire, United Kingdom, OX3 7LJLocal Institution - 0540 | Birmingham West Midlands, United Kingdom, B15 2TTLocal Institution - 0601 | Cardiff , United Kingdom, CF14 2TLLocal Institution - 0602 | Dorchester , United Kingdom, DT1 2JYLocal Institution - 0307 | Glasgow , United Kingdom, G12 0YNRoyal Marsden Hospital Sutton | London , United Kingdom, SM2 5PTRoyal Marsden Hospital | London , United Kingdom, SW3 6JJMaidstone and Tunbridge Wells NHS Trust | Maidstone , United Kingdom, ME16 9QQLocal Institution - 0310 | Newcastle upon Tyne , United Kingdom, NE7 7DN |
| Investigators | Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb |
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