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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

2026-10-23

Healthy Volunteers

No

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

Highlands Oncology Group

Springdale, Arkansas, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Local Institution - 0330

Los Angeles, California, United States

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

Orange, California, United States

California Pacific Medical Center - Pacific Campus

San Francisco, 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 - 0326

Atlanta, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Marietta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Local Institution - 0638

Fort Wayne, Indiana, United States

University of Iowa

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

Laura and Isaac Perlmutter Cancer Center at NYU Langone

Mineola, New York, United States

New York Cancer and Blood Specialists

Shirley, New York, United States

Local Institution - 0290

Charlotte, North Carolina, United States

Sanford Fargo Medical Center

Fargo, North Dakota, United States

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 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

Baylor College of Medicine Medical Center

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

Centro Médico Fleischer

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto Alexander Fleming

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

ABB, Buenos Aires F.D., Argentina

Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L

San Miguel de Tucumán, Tucumán Province, Argentina

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

Buenos Aires, Argentina

Sanatorio Allende - Nueva Córdoba

Córdoba, Argentina

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

GenesisCare St Leonards

St Leonards, New South Wales, Australia

Westmead Hospital

Westmead, 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

Flinders Medical Centre

Adelaide, South Australia, Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

Grampians Health

Ballarat Central, Victoria, Australia

Northern Hospital

Epping, Victoria, Australia

Cabrini Hospital - Malvern

Malvern, 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 - 0164

Feldkirch, Austria

Krankenhaus Der Barmherzigen Schwestern Linz

Linz, Austria

Universitaetsklinik Salzburg

Salzburg, Austria

Universitätsklinikum St. Pölten

Sankt Pölten, Austria

Medizinische Universitaet Wien/AKH

Vienna, Austria

Imelda General Hospital

Bonheiden, Antwerpen, Belgium

Antwerp University Hospital

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

Centro Integrado de Oncologia de Curitiba

Curitiba, Paraná, Brazil

Liga Norte Riograndense Contra o Câncer

Natal, Rio Grande do Norte, Brazil

Local Institution - 0375

Porto Alegre, Rio Grande do Sul, Brazil

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Instituto de Oncologia Saint Gallen

Santa Cruz do Sul, Rio Grande do Sul, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

Faculdade de Medicina de Sao Jose do Rio Preto

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

Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUS

Sherbrooke, Quebec, Canada

Bradfordhill

Recoleta, Santiago Metropolitan, Chile

Fundacion Oncologia Arturo Lopez Perez

Santiago, Santiago Metropolitan, Chile

Local Institution - 0175

Santiago, Santiago Metropolitan, Chile

And 186 more locations on ClinicalTrials.gov