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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

RecruitingPhase 2/3

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

Who can join

Ages 18 and older · All sexes

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.

About the study

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

What is being tested

Sponsor: Bristol-Myers Squibb · Participants: 990 · Started: Dec 31, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07221357

Locations in the U.S.

ArizonaLocal Institution - 0428, Tucson (Not yet recruiting)
ArkansasHighlands Oncology Group, Springdale
CaliforniaUSC/Norris Comprehensive Cancer Center, Los Angeles
University of California, Irvine (UCI) Health - UC Irvine Medical Center, Orange
Local Institution - 0317, San Francisco (Not yet recruiting)
FloridaFlorida Cancer Specialists - East, Cape Coral
Florida Cancer Specialists - North, St. Petersburg
Moffitt Cancer Center, Tampa
GeorgiaLocal Institution - 0326, Atlanta (Not yet recruiting)
Northside Hospital, Atlanta
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital, Marietta
IllinoisLocal Institution - 0433, Chicago (Not yet recruiting)
IndianaLocal Institution - 0638, Fort Wayne (Not yet recruiting)
IowaUniversity of Iowa, Iowa City
MarylandLocal Institution - 0262, Baltimore (Not yet recruiting)
Maryland Oncology Hematology - Silver Spring, Silver Spring
MichiganLocal Institution - 0430, Ann Arbor (Not yet recruiting)
Local Institution - 0254, Grand Rapids (Not yet recruiting)
MinnesotaMinnesota Oncology, Maple Grove
MissouriLocal Institution - 0318, Kansas City (Not yet recruiting)
Washington University School OF Medicine-Siteman Cancer Center, St Louis
NebraskaUniversity Of Nebraska Medical Center, Omaha
New YorkNorthwell Health/ RJ Zuckerberg Cancer Center, Lake Success
Laura and Isaac Perlmutter Cancer Center at NYU Langone, Mineola
New York Cancer and Blood Specialists, Shirley
North CarolinaLocal Institution - 0290, Charlotte (Not yet recruiting)
North DakotaSanford Fargo Medical Center, Fargo
OhioThe James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center, Columbus
PennsylvaniaLehigh Valley Health Network, Allentown
Local Institution - 0604, Pittsburgh (Not yet recruiting)
South DakotaSanford Cancer Center, Sioux Falls
TennesseeLocal Institution - 0333, Nashville (Not yet recruiting)
SCRI Oncology Partners, Nashville
TexasTexas Oncology Dallas Fort Worth West (DFWW) - Arlington Cancer Center North, Arlington
Texas Oncology, PA, Austin
Baylor College of Medicine Medical Center, Houston
Texas Oncology - San Antonio, San Antonio
UtahLocal Institution - 0426, Salt Lake City (Not yet recruiting)
VirginiaLocal Institution - 0278, Fairfax (Not yet recruiting)
Virginia Oncology Associates, Norfolk
WashingtonLocal Institution - 0491, Edmonds (Not yet recruiting)
Local Institution - 0253, Seattle (Not yet recruiting)
Local Institution - 0629, Spokane (Not yet recruiting)
Northwest Cancer Specialists, P.C., Vancouver

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.