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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
Sponsor: Bristol-Myers Squibb
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
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
990
Start Date
2025-12-31
Completion Date
2034-03-11
Last Updated
2026-03-31
Healthy Volunteers
No
Interventions
Pumitamig
Specified dose on specified days
FOLFOX
Specified dose on specified days
FOLFIRI
Specified dose on specified days
Bevacizumab
Specified dose on specified days
CAPOX
Specified dose on specified days
Locations (263)
Local Institution - 0428
Tucson, Arizona, United States
Local Institution - 0432
Springdale, Arkansas, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Local Institution - 0345
Orange, California, United States
Local Institution - 0317
San Francisco, California, United States
Local Institution - 0330
Santa Monica, California, United States
Local Institution - 0293
Stanford, California, United States
Florida Cancer Specialists - East
Cape Coral, Florida, United States
Florida Cancer Specialists - North
St. Petersburg, Florida, United States
Local Institution - 0269
Tampa, Florida, United States
Local Institution - 0276
Duluth, Georgia, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, United States
Local Institution - 0030
Chicago, Illinois, United States
Local Institution - 0433
Chicago, Illinois, United States
Local Institution - 0335
Iowa City, Iowa, United States
Local Institution - 0262
Baltimore, Maryland, United States
Maryland Oncology Hematology - Silver Spring
Silver Spring, Maryland, United States
Local Institution - 0471
Boston, Massachusetts, United States
Local Institution - 0430
Ann Arbor, Michigan, United States
Local Institution - 0254
Grand Rapids, Michigan, United States
Minnesota Oncology
Maple Grove, Minnesota, United States
Local Institution - 0318
Kansas City, Missouri, United States
Washington University School OF Medicine-Siteman Cancer Center
St Louis, Missouri, United States
Local Institution - 0334
Omaha, Nebraska, United States
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, United States
Local Institution - 0270
Mineola, New York, United States
Local Institution - 0273
New Hyde Park, New York, United States
Local Institution - 0290
Charlotte, North Carolina, United States
Local Institution - 0526
Fargo, North Dakota, United States
Local Institution - 0339
Columbus, Ohio, United States
Local Institution - 0605
Oklahoma City, Oklahoma, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Local Institution - 0604
Pittsburgh, Pennsylvania, United States
Local Institution - 0312
Sioux Falls, South Dakota, United States
Local Institution - 0333
Nashville, Tennessee, United States
Sarah Cannon Institute
Nashville, Tennessee, United States
Texas Oncology Dallas Fort Worth West (DFWW) - Arlington Cancer Center North
Arlington, Texas, United States
Texas Oncology, PA
Austin, Texas, United States
Local Institution - 0252
Houston, Texas, United States
Texas Oncology - San Antonio
San Antonio, Texas, United States
Local Institution - 0426
Salt Lake City, Utah, United States
Local Institution - 0278
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Local Institution - 0491
Edmonds, Washington, United States
Local Institution - 0253
Seattle, Washington, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States
Local Institution - 0071
ABB, Buenos Aires F.D., Argentina
Local Institution - 0174
Buenos Aires, Argentina
Local Institution - 0073
Buenos Aires, Argentina
Local Institution - 0069
Buenos Aires, Argentina
Local Institution - 0172
Buenos Aires, Argentina
Local Institution - 0277
Liverpool, New South Wales, Australia
Local Institution - 0157
St Leonards, New South Wales, Australia
Local Institution - 0274
Birtinya, Queensland, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Local Institution - 0191
Woolloongabba, Queensland, Australia
Local Institution - 0156
Adelaide, South Australia, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Local Institution - 0196
Ballarat Central, Victoria, Australia
Local Institution - 0190
Epping, Victoria, Australia
Local Institution - 0194
Shepparton, Victoria, Australia
Local Institution - 0519
St Albans, Victoria, Australia
St. John of God Murdoch Hospital
Murdoch, Western Australia, Australia
Local Institution - 0160
Malvern, Australia
Local Institution - 0159
Wentworthville, Australia
Local Institution - 0078
Linz, Austria
Local Institution - 0178
Salzburg, Austria
Local Institution - 0082
Vienna, Austria
Local Institution - 0622
Bonheiden, Antwerpen, Belgium
Local Institution - 0103
Edegem, Antwerpen, Belgium
Local Institution - 0620
Charleroi, Hainaut, Belgium
Local Institution - 0179
Brussels, MO, Belgium
Local Institution - 0122
Roeselare, West-Vlaanderen, Belgium
Local Institution - 0118
Brussels, Belgium
Local Institution - 0115
Leuven, Belgium
Local Institution - 0267
Curitiba, Paraná, Brazil
Local Institution - 0331
Natal/RN, Rio Grande do Norte, Brazil
Local Institution - 0375
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0342
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0373
Santa Cruz do Sul, Rio Grande do Sul, Brazil
Local Institution - 0444
Chapecó, Santa Catarina, Brazil
Local Institution - 0266
Barretos, São Paulo, Brazil
Local Institution - 0264
São José do Rio Preto, Brazil
Local Institution - 0268
São Paulo, Brazil
Local Institution - 0341
São Paulo, Brazil
Local Institution - 0550
Calgary, Alberta, Canada
Local Institution - 0260
Halifax, Nova Scotia, Canada
Local Institution - 0255
Ottawa, Ontario, Canada
Local Institution - 0421
Toronto, Ontario, Canada
Local Institution - 0258
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Local Institution - 0261
Sherbrooke, Quebec, Canada
Local Institution - 0171
Recoleta, Santiago Metropolitan, Chile
Local Institution - 0463
Santiago, Santiago Metropolitan, Chile
Local Institution - 0175
Santiago, Santiago Metropolitan, Chile
Local Institution - 0595
Hefei, Anhui, China
Local Institution - 0499
Chongqing, Chongqing Municipality, China
Local Institution - 0354
Fuzhou, Fujian, China
Local Institution - 0388
Fuzhou Fujian, Fujian, China
Local Institution - 0414
Guangzhou, Guangdong, China
Local Institution - 0130
Guangzhou, Guangdong, China
Local Institution - 0390
Tianjin, Hebei, China
Local Institution - 0353
Harbin, Heilongjiang, China
Local Institution - 0384
Nanyang, Henan, China
Local Institution - 0391
Wuhan, Hubei, China
Local Institution - 0376
Changsha, Hunan, China
Local Institution - 0411
Changsha, Hunan, China
Local Institution - 0398
Yangzhou, Jiangsu, China
Local Institution - 0381
Nanchang, Jiangxi, China
Local Institution - 0352
Shenyang, Liaoning, China
Local Institution - 0355
Shenyang, Liaoning, China
Local Institution - 0382
Jinan, Shandong, China
Local Institution - 0378
Shanghai, Shanghai Municipality, China
Local Institution - 0498
Chengdu, Sichuan, China
Local Institution - 0360
Hangzhou, Zhejiang, China
Local Institution - 0383
Hangzhou, Zhejiang, China
Local Institution - 0409
Beijing, China
Local Institution - 0457
Hangzhou, China
Local Institution - 0416
Nanjing, Jiangsu, China
Local Institution - 0356
Shanghai, China
Local Institution - 0412
Wuhan, China
Local Institution - 0489
Prague, Praha 10, Czechia
Local Institution - 0248
Prague, Praha 5, Czechia
Local Institution - 0461
Prague, Praha, Hlavní Mesto, Czechia
Local Institution - 0180
Brno, Czechia
Local Institution - 0188
Hradec Králové, Czechia
Local Institution - 0467
Olomouc, Czechia
Local Institution - 0202
Marseille, Bouches-du-Rhône, France
Local Institution - 0590
Besançon, Doubs, France
Local Institution - 0182
Saint-Herblain, Loire-Atlantique, France
Local Institution - 0618
Lorient, Morbihan, France
Local Institution - 0613
Lille, Nord, France
Local Institution - 0125
Nantes, Pays de la Loire Region, France
Local Institution - 0121
Marseille, Provence-Alpes-Côte d'Azur Region, France
Local Institution - 0138
Dijon, France
Local Institution - 0616
Limoges, France
Hôpital Saint Antoine
Paris, France
Local Institution - 0181
Pessac, France
Local Institution - 0127
Rouen, France
Local Institution - 0097
Toulose, France
Local Institution - 0098
Villejuif, France
Local Institution - 0591
Erlangen, Bavaria, Germany
Local Institution - 0607
Hanover, Lower Saxony, Germany
Local Institution - 0033
Dresden, Saxony, Germany
Local Institution - 0035
Berlin, Germany
Local Institution - 0061
Bochum, Germany
Local Institution - 0588
Chemnitz, Germany
Local Institution - 0057
Düsseldorf, Germany
Local Institution - 0040
Frankfurt, Germany
Local Institution - 0058
Göttingen, Germany
Local Institution - 0039
Hamburg, Germany
Local Institution - 0594
Hamburg, Germany
Local Institution - 0041
Leipzig, Germany
Local Institution - 0060
Mainz, Germany
Local Institution - 0059
Mannheim, Germany
Klinikum Neuperlach
München, Germany
Local Institution - 0037
Ulm, Germany
Local Institution - 0203
Veszprém, Hungary
Local Institution - 0010
Nashik, Dādra and Nagar Haveli and Damān and Diu, India
Local Institution - 0036
Mumbai, Maharashtra, India
Local Institution - 0552
Mumbai, Maharashtra, India
Local Institution - 0006
Delhi, India
Local Institution - 0554
Delhi, India
Local Institution - 0557
Puducherry, India
Local Institution - 0038
Pune, India
Local Institution - 0617
Castellana Grotte, Bari, Italy
Local Institution - 0584
San Giovanni Rotondo, Foggia, Italy
Local Institution - 0619
Tricase, Lecce, Italy
Local Institution - 0231
Milan, Milano, Italy
Local Institution - 0609
Avellino, Italy
Local Institution - 0227
Catania, Italy
Local Institution - 0615
La Spezia, Italy
Local Institution - 0111
Milan, Italy
Local Institution - 0236
Naples, Italy
Local Institution - 0221
Padova, Italy
Local Institution - 0226
Pisa, Italy
Local Institution - 0612
Ravenna, Italy
Local Institution - 0233
Reggio Emilia, Italy
Local Institution - 0053
Chiba, Chiba, Japan
Local Institution - 0045
Matsuyama, Ehime, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Local Institution - 0047
Kobe, Hyōgo, Japan
Local Institution - 0056
Yokohama, Kanagawa, Japan
Local Institution - 0476
Kurashiki, Okayama-ken, Japan
The University of Osaka Hospital
Suita, Osaka, Japan
Local Institution - 0521
Takatsuki, Osaka, Japan
Local Institution - 0046
Hidaka, Saitama, Japan
Local Institution - 0475
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan
Local Institution - 0473
Chikusa-ku, Japan
Local Institution - 0052
Fukuoka, Japan
Local Institution - 0493
Kashiwa, Japan
Local Institution - 0597
Kitaadachi-gun, Japan
Local Institution - 0506
Osaka, Japan
Local Institution - 0067
Sendai, Japan
Local Institution - 0054
Sunto-gun, Japan
Local Institution - 0173
Eindhoven, North Brabant, Netherlands
Local Institution - 0112
Amsterdam, North Holland, Netherlands
Local Institution - 0170
Groningen, Netherlands
Local Institution - 0216
Tilburg, Netherlands
Local Institution - 0167
Utrecht, Netherlands
Local Institution - 0364
Krakow, Lesser Poland Voivodeship, Poland
Local Institution - 0452
Jelenia Góra, Lower Silesian Voivodeship, Poland
Luxmed Onkologia sp. z o. o.
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0525
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0359
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0365
Brzozów, Podkarpackie Voivodeship, Poland
Local Institution - 0626
Gdansk, Pomeranian Voivodeship, Poland
Local Institution - 0451
Gliwice, Silesian Voivodeship, Poland
Local Institution - 0361
Koszalin, West Pomeranian Voivodeship, Poland
Local Institution - 0362
Opole, Poland
Local Institution - 0282
Cluj-Napoca, Cluj, Romania
Local Institution - 0100
Bucharest, Romania
Local Institution - 0142
Cluj-Napoca, Romania
Local Institution - 0189
Craiova, Romania
Local Institution - 0370
Iași, Romania
Local Institution - 0143
Iași, Romania
Local Institution - 0145
Singapore, Central Singapore, Singapore
Local Institution - 0147
Singapore, Singapore
Local Institution - 0285
Singapore, Singapore
Local Institution - 0511
Singapore, Singapore
Local Institution - 0406
Seongnam, Gyeonggido, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0394
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0395
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0405
Seoul, South Korea
Local Institution - 0163
Badalona, Barcelona [Barcelona], Spain
Local Institution - 0240
Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0624
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0229
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0225
Pamplona, Navarre, Spain
Local Institution - 0472
Elche (alicante), Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Local Institution - 0232
Málaga, Spain
Local Institution - 0625
Salamanca, Spain
Local Institution - 0593
Santiago de Compostela, Spain
Local Institution - 0234
Seville, Spain
Local Institution - 0074
Stockholm, Stockholm County, Sweden
Local Institution - 0185
Gothenburg, Västra Götaland County, Sweden
Local Institution - 0400
Lund, Sweden
Local Institution - 0301
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Local Institution - 0289
Kaohsiung City, Taiwan
Local Institution - 0291
Tainan, Taiana, Taiwan
Local Institution - 0297
Taipei, Taiwan
Local Institution - 0300
Taipei, Taiwan
Local Institution - 0449
Taoyuan District, Taiwan
Local Institution - 0020
Adana, Turkey (Türkiye)
Local Institution - 0065
Ankara, Turkey (Türkiye)
Local Institution - 0018
Erzurum, Turkey (Türkiye)
Local Institution - 0296
Istanbul, Turkey (Türkiye)
Local Institution - 0295
Kadiköy/Istanbul, Turkey (Türkiye)
The Christie NHS Foundation Trust
Manchester, Lancashire, United Kingdom
Local Institution - 0600
Enfield, London, United Kingdom
Local Institution - 0366
Oxford, Oxfordshire, United Kingdom
Local Institution - 0540
Birmingham, West Midlands, United Kingdom
Local Institution - 0601
Cardiff, United Kingdom
Local Institution - 0602
Dorchester, United Kingdom
Local Institution - 0307
Glasgow, United Kingdom
Royal Marsden Hospital Sutton
London, United Kingdom
Royal Marsden Hospital
London, United Kingdom
Maidstone and Tunbridge Wells NHS Trust
Maidstone, United Kingdom
Local Institution - 0310
Newcastle upon Tyne, United Kingdom