RecruitingInterventionalPhase 2/Phase 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

NCT ID: NCT07221357Sponsor: Bristol-Myers SquibbLast updated: 2026-05-28

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

Arms & interventions

DrugPumitamig
Specified dose on specified days
DrugFOLFOX
Specified dose on specified days
DrugFOLFIRI
Specified dose on specified days
DrugBevacizumab
Specified dose on specified days
DrugCAPOX
Specified dose on specified days

Outcome measures

Primary

Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Phase 2
Time frame: Up to 5 years
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)
Phase 3
Time frame: Up to 5 years
Overall Survival (OS)
Phase 3
Time frame: Up to 5 years

Secondary

PFS by RECIST v1.1 per investigator assessment
Time frame: Up to 5 years
Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment
Time frame: Up to 5 years
Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment
Time frame: Up to 5 years
Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment
Time frame: Up to 5 years
Recommended dose of Pumitamig for Phase 3
Time frame: Up to 5 years
OR by RECIST v1.1 per BICR
Time frame: Up to 5 years
DOR by RECIST v1.1 per BICR
Time frame: Up to 5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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.

Study locations (49)

Local Institution - 0428

Tucson, Arizona, 85724

Not Yet Recruiting

Site 0428 · Contact

Local Institution - 0432

Springdale, Arkansas, 72762

Not Yet Recruiting

Site 0432 · Contact

Local Institution - 0447

La Jolla, California, 92037

Not Yet Recruiting

Site 0447 · Contact

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Recruiting

Sandra Algaze, Site 0263 · Contact

818-406-8072

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

Orange, California, 92868

Recruiting

Farshid Dayyani, Site 0345 · Contact

714-456-5153

Local Institution - 0317

San Francisco, California, 94115

Not Yet Recruiting

Site 0317 · Contact

Local Institution - 0330

Santa Monica, California, 90404

Not Yet Recruiting

Site 0330 · Contact

Local Institution - 0293

Stanford, California, 94305

Not Yet Recruiting

Site 0293 · Contact

Florida Cancer Specialists - East

Cape Coral, Florida, 33990

Recruiting

Todd Gersten, Site 0574 · Contact

561-366-4100

Florida Cancer Specialists - North

St. Petersburg, Florida, 33705

Recruiting

Maen Hussein, Site 0575 · Contact

727-216-1143

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting

Tiago Biachi de Castria, Site 0269 · Contact

646-673-0129

Local Institution - 0276

Atlanta, Georgia, 30342

Not Yet Recruiting

Site 0276 · Contact

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Marietta, Georgia, 30060

Recruiting

Walid Shaib, Site 0369 · Contact

770-281-5124

Local Institution - 0030

Chicago, Illinois, 60611

Not Yet Recruiting

Site 0030 · Contact

Local Institution - 0433

Chicago, Illinois, 60637

Not Yet Recruiting

Site 0433 · Contact

Local Institution - 0638

Fort Wayne, Indiana, 46805

Not Yet Recruiting

Site 0638 · Contact

Local Institution - 0335

Iowa City, Iowa, 52242

Not Yet Recruiting

Site 0335 · Contact

Local Institution - 0262

Baltimore, Maryland, 21287

Not Yet Recruiting

Site 0262 · Contact

Maryland Oncology Hematology - Silver Spring

Silver Spring, Maryland, 20904

Recruiting

Danubia Hester, Site 0580 · Contact

Local Institution - 0471

Boston, Massachusetts, 02114

Withdrawn

Local Institution - 0430

Ann Arbor, Michigan, 48109

Not Yet Recruiting

Site 0430 · Contact

Local Institution - 0254

Grand Rapids, Michigan, 49546

Not Yet Recruiting

Site 0254 · Contact

Minnesota Oncology

Maple Grove, Minnesota, 55369

Recruiting

Robert Delaune, Site 0572 · Contact

Local Institution - 0318

Kansas City, Missouri, 64111

Not Yet Recruiting

Site 0318 · Contact

Washington University School OF Medicine-Siteman Cancer Center

St Louis, Missouri, 63110

Recruiting

Moh'd Khushman, Site 0336 · Contact

314-273-3564

University Of Nebraska Medical Center

Omaha, Nebraska, 68198

Recruiting

Laura Tenner, Site 0334 · Contact

402-559-5600

Northwell Health/ RJ Zuckerberg Cancer Center

Lake Success, New York, 11042

Recruiting

Nicholas Hornstein, Site 0429 · Contact

323-533-7275

Local Institution - 0270

Mineola, New York, 11501

Not Yet Recruiting

Site 0270 · Contact

Local Institution - 0273

New Hyde Park, New York, 11042

Not Yet Recruiting

Site 0273 · Contact

Local Institution - 0290

Charlotte, North Carolina, 28207

Not Yet Recruiting

Site 0290 · Contact

Sanford Fargo Medical Center

Fargo, North Dakota, 58102

Recruiting

Jeffrey Wiisanen, Site 0526 · Contact

701-234-2358

Local Institution - 0339

Columbus, Ohio, 43210

Not Yet Recruiting

Site 0339 · Contact

Local Institution - 0605

Oklahoma City, Oklahoma, 73104

Not Yet Recruiting

Site 0605 · Contact

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103

Recruiting

Maged Khalil, Site 0348 · Contact

Local Institution - 0604

Pittsburgh, Pennsylvania, 15232

Not Yet Recruiting

Site 0604 · Contact

Sanford Cancer Center

Sioux Falls, South Dakota, 57104

Recruiting

Jonathan Bleeker, Site 0312 · Contact

605-328-8000

Local Institution - 0333

Nashville, Tennessee, 37203

Not Yet Recruiting

Site 0333 · Contact

SCRI Oncology Partners

Nashville, Tennessee, 37203

Recruiting

Meredith Pelster, Site 0570 · Contact

615-986-4366

Texas Oncology Dallas Fort Worth West (DFWW) - Arlington Cancer Center North

Arlington, Texas, 76012

Recruiting

Laith Abushahin, Site 0573 · Contact

Texas Oncology, PA

Austin, Texas, 78705

Recruiting

Vivian Cline, Site 0571 · Contact

512-427-9400

Local Institution - 0252

Houston, Texas, 77030

Not Yet Recruiting

Site 0252 · Contact

Texas Oncology - San Antonio

San Antonio, Texas, 78240

Recruiting

Sridhar Beeram, Site 0576 · Contact

210-615-1988

Local Institution - 0426

Salt Lake City, Utah, 84102

Not Yet Recruiting

Site 0426 · Contact

Local Institution - 0278

Fairfax, Virginia, 22031

Not Yet Recruiting

Site 0278 · Contact

Virginia Oncology Associates

Norfolk, Virginia, 23502

Recruiting

YUE ZHANG, Site 0577 · Contact

757-466-8683

Local Institution - 0491

Edmonds, Washington, 98026-8032

Not Yet Recruiting

Site 0491 · Contact

Local Institution - 0253

Seattle, Washington, 98109

Not Yet Recruiting

Site 0253 · Contact

Local Institution - 0629

Spokane, Washington, 99218

Not Yet Recruiting

Site 0629 · Contact

Northwest Cancer Specialists, P.C.

Vancouver, Washington, 98684

Recruiting

Spencer Shao, Site 0578 · Contact

503-528-5005