NCT07221357From ClinicalTrials.govRecruiting

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

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

Untreated, Unresectable, or Metastatic Colorectal Cancer

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Bristol-Myers Squibb
Enrolment target: 990
Started: 31 December 2025
Main results due: 2 February 2030
Study sites: 285
Registry updated: 23 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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.

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(285)

Local Institution - 0428
Tucson, Arizona, United States
Not yet recruiting
Highlands Oncology Group
Springdale, Arkansas, United States
Recruiting
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Recruiting
Local Institution - 0330
Los Angeles, California, United States
Withdrawn
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, United States
Recruiting
Local Institution - 0317
San Francisco, California, United States
Not yet recruiting
Florida Cancer Specialists - East
Cape Coral, Florida, United States
Recruiting
Florida Cancer Specialists - North
St. Petersburg, Florida, United States
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
Local Institution - 0326
Atlanta, Georgia, United States
Not yet recruiting
Northside Hospital
Atlanta, Georgia, United States
Recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, United States
Recruiting
Local Institution - 0433
Chicago, Illinois, United States
Not yet recruiting
Local Institution - 0638
Fort Wayne, Indiana, United States
Not yet recruiting
University of Iowa
Iowa City, Iowa, United States
Recruiting
Local Institution - 0262
Baltimore, Maryland, United States
Not yet recruiting
Maryland Oncology Hematology - Silver Spring
Silver Spring, Maryland, United States
Recruiting
Local Institution - 0471
Boston, Massachusetts, United States
Withdrawn
Local Institution - 0430
Ann Arbor, Michigan, United States
Not yet recruiting
Local Institution - 0254
Grand Rapids, Michigan, United States
Not yet recruiting
Minnesota Oncology
Maple Grove, Minnesota, United States
Recruiting
Local Institution - 0318
Kansas City, Missouri, United States
Not yet recruiting
Washington University School OF Medicine-Siteman Cancer Center
St Louis, Missouri, United States
Recruiting
University Of Nebraska Medical Center
Omaha, Nebraska, United States
Recruiting
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, United States
Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Mineola, New York, United States
Recruiting
New York Cancer and Blood Specialists
Shirley, New York, United States
Recruiting
Local Institution - 0290
Charlotte, North Carolina, United States
Not yet recruiting
Sanford Fargo Medical Center
Fargo, North Dakota, United States
Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Recruiting
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Recruiting
Local Institution - 0604
Pittsburgh, Pennsylvania, United States
Not yet recruiting
Sanford Cancer Center
Sioux Falls, South Dakota, United States
Recruiting
Local Institution - 0333
Nashville, Tennessee, United States
Not yet recruiting
SCRI Oncology Partners
Nashville, Tennessee, United States
Recruiting
Texas Oncology Dallas Fort Worth West (DFWW) - Arlington Cancer Center North
Arlington, Texas, United States
Recruiting
Texas Oncology, PA
Austin, Texas, United States
Recruiting
Baylor College of Medicine Medical Center
Houston, Texas, United States
Recruiting
Texas Oncology - San Antonio
San Antonio, Texas, United States
Recruiting
Local Institution - 0426
Salt Lake City, Utah, United States
Not yet recruiting
Local Institution - 0278
Fairfax, Virginia, United States
Not yet recruiting
Virginia Oncology Associates
Norfolk, Virginia, United States
Recruiting
Local Institution - 0491
Edmonds, Washington, United States
Not yet recruiting
Local Institution - 0253
Seattle, Washington, United States
Not yet recruiting
Local Institution - 0629
Spokane, Washington, United States
Not yet recruiting
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States
Recruiting
Hospital Británico de Buenos Aires
CABA, Buenos Aires, Argentina
Recruiting
Centro Médico Fleischer
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Recruiting
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Recruiting
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., Argentina
Recruiting
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
San Miguel de Tucumán, Tucumán Province, Argentina
Recruiting
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
Buenos Aires, Argentina
Recruiting
Sanatorio Allende - Nueva Córdoba
Córdoba, Argentina
Recruiting
Local Institution - 0643
Camperdown, New South Wales, Australia
Not yet recruiting
Liverpool Hospital
Liverpool, New South Wales, Australia
Recruiting
GenesisCare St Leonards
St Leonards, New South Wales, Australia
Recruiting
Westmead Hospital
Westmead, New South Wales, Australia
Recruiting
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Recruiting
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Recruiting
Gallipoli Medical Research Ltd
Brisbane, Queensland, Australia
Recruiting

Showing 60 of 285 sites — filter to narrow it down. 185 of the 285 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07221357. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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