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RECRUITING

NCT07221357

PHASE2/PHASE3

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

View on ClinicalTrials.gov

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

2026-05-28

Healthy Volunteers

Conditions

Untreated, Unresectable, or Metastatic Colorectal Cancer

Interventions

DRUG

Pumitamig

Specified dose on specified days

DRUG

FOLFOX

Specified dose on specified days

DRUG

FOLFIRI

Specified dose on specified days

DRUG

Bevacizumab

Specified dose on specified days

DRUG

CAPOX

Specified dose on specified days

Locations (286)

Local Institution - 0428

Tucson, Arizona, United States

Local Institution - 0432

Springdale, Arkansas, United States

Local Institution - 0447

La Jolla, California, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

University of California, Irvine (UCI) Health - UC Irvine Medical Center

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

Moffitt Cancer Center

Tampa, Florida, United States

Local Institution - 0276

Atlanta, 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 - 0638

Fort Wayne, Indiana, 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

University Of Nebraska Medical Center

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

Sanford Fargo Medical Center

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

Sanford Cancer Center

Sioux Falls, South Dakota, United States

Local Institution - 0333

Nashville, Tennessee, United States

SCRI Oncology Partners

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

Local Institution - 0629

Spokane, Washington, United States

Northwest Cancer Specialists, P.C.

Vancouver, Washington, United States

Hospital Británico de Buenos Aires

CABA, Buenos Aires, Argentina

Instituto Alexander Fleming

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0071

ABB, Buenos Aires F.D., Argentina

Local Institution - 0632

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0174

Buenos Aires, Argentina

Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)

Buenos Aires, Argentina

Local Institution - 0630

Córdoba, Argentina

Local Institution - 0643

Camperdown, New South Wales, Australia

Local Institution - 0277

Liverpool, New South Wales, Australia

GenesisCare St Leonards

St Leonards, New South Wales, Australia

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Gallipoli Medical Research Ltd

Brisbane, Queensland, Australia

Local Institution - 0156

Adelaide, South Australia, Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

Grampians Health

Ballarat Central, Victoria, Australia

Local Institution - 0190

Epping, Victoria, Australia

Goulburn Valley Health

Shepparton, Victoria, Australia

Western Health-Sunshine & Footscray Hospitals

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 - 0164

Feldkirch, Austria

Krankenhaus Der Barmherzigen Schwestern Linz

Linz, Austria

Universitaetsklinik Salzburg

Salzburg, Austria

Local Institution - 0176

Sankt Pölten, Austria

Local Institution - 0082

Vienna, Austria

Local Institution - 0622

Bonheiden, Antwerpen, Belgium

Local Institution - 0103

Edegem, Antwerpen, Belgium

Cliniques universitaires Saint-Luc

Brussels, Bruxelles-Capitale, Région de, Belgium

Local Institution - 0620

Charleroi, Hainaut, Belgium

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

AZ Delta vzw

Roeselare, West-Vlaanderen, Belgium

Local Institution - 0118

Brussels, 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 - 0424

Toronto, Ontario, Canada

Local Institution - 0421

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal

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 - 0412

Wuhan, Hubei, 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

Masarykuv onkologicky ustav

Brno, Brno-město, Czechia

Local Institution - 0489

Prague, Praha 10, Czechia

Fakultni nemocnice Motol a Homolka

Prague, Praha 5, Czechia

Local Institution - 0461

Prague, Praha, Hlavní Mesto, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Local Institution - 0467

Olomouc, Czechia

CHU Bordeaux Haut-Leveque

Pessac, Aquitaine, France

Local Institution - 0590

Besançon, Doubs, France

CHU Rangueil

Toulouse, Haute-Garonne, France

CHU Charles Nicolle

Rouen, Haute-Normandie, 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

Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand

Dijon, France

Local Institution - 0616

Limoges, France

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

Marseille, France

Hôpital Saint Antoine

Paris, France

Local Institution - 0634

Suresnes, France

Local Institution - 0098

Villejuif, France

Local Institution - 0591

Erlangen, Bavaria, Germany

Local Institution - 0607

Hanover, Lower Saxony, Germany

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Saxony, Germany

Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin

Berlin, Germany

Local Institution - 0061

Bochum, Germany

Local Institution - 0588

Chemnitz, Germany

Marien Hospital Düsseldorf

Düsseldorf, Germany

Krankenhaus Nordwest GmbH

Frankfurt, Germany

Universitaetsmedizin Goettingen

Göttingen, Germany

Facharztzentrum Eppendorf

Hamburg, Germany

Local Institution - 0594

Hamburg, Germany

Universitatsklinikum Leipzig

Leipzig, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

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

IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy

Local Institution - 0619

Tricase, Lecce, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Milano, Italy

Local Institution - 0614

Aviano, Pordenone, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, Italy

Istituto Oncologico Veneto IRCCS

Padova, Veneto, Italy

Local Institution - 0609

Avellino, Italy

Local Institution - 0610

Bari, Italy

Azienda Ospedaliera Garibaldi

Catania, Italy

Local Institution - 0615

La Spezia, Italy

Local Institution - 0111

Milan, Italy

Ospedale San Raffaele

Milan, Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Naples, Italy

Local Institution - 0612

Ravenna, Italy

Local Institution - 0233

Reggio Emilia, Italy

Local Institution - 0641

Toyoake, Aichi-ken, Japan

Local Institution - 0053

Chiba, Chiba, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Local Institution - 0056

Yokohama, Kanagawa, Japan

Local Institution - 0476

Kurashiki, Okayama-ken, Japan

The University of Osaka Hospital

Suita, Osaka, Japan

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, Japan

Local Institution - 0046

Hidaka, Saitama, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

Local Institution - 0642

Yamagata, Yamagata, Japan

Local Institution - 0473

Chikusa-ku, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Local Institution - 0597

Kitaadachi-gun, Japan

Osaka International Cancer Institute

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

Luxmed Onkologia sp. z o. o.

Warsaw, Masovian Voivodeship, Poland

Local Institution - 0525

Warsaw, Masovian Voivodeship, Poland

Local Institution - 0359

Warsaw, Masovian Voivodeship, Poland

SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu

Opole, Opole 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 - 0452

Jelenia Góra, Poland

Fundeni Clinical Institute

Bucharest, Bucharest, Romania

Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor

Cluj-Napoca, Cluj, Romania

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj, Romania

Institutul Oncologic Cluj

Cluj-Napoca, Romania

Local Institution - 0139

Floresti/ Cluj, Romania

S.C. Centrul de Oncologie Euroclinic S.R.L.

Iași, Romania

Institutul Regional de Oncologie

Iași, Romania

National Cancer Centre Singapore

Singapore, Central Singapore, Singapore

National University Hospital

Singapore, Singapore

Local Institution - 0285

Singapore, Singapore

Local Institution - 0511

Singapore, Singapore

Local Institution - 0635

Goyang-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam, Gyeonggido, South Korea

Local Institution - 0637