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Pumitamig plus chemotherapy versus bevacizumab plus chemotherapy for untreated 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

Phase2; Phase3 Interventional Bristol-Myers Squibb · NCT07221357

This trial tests whether adding the new drug pumitamig to standard chemotherapy works better than bevacizumab plus chemotherapy for people with previously untreated, unresectable, or metastatic colorectal cancer who do not have MSI‑H/dMMR or BRAF V600E mutations.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment990 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionschemotherapy, bevacizumab
Locations279 sites (Tucson, Arizona and 278 other locations)
Trial IDNCT07221357 on ClinicalTrials.gov

What this trial studies

This randomized Phase 2/3 trial compares pumitamig combined with one of several standard chemotherapy backbones (FOLFOX, FOLFIRI, or CAPOX) against bevacizumab combined with the same chemotherapy options in adults with previously untreated, unresectable or metastatic colorectal adenocarcinoma. Eligible participants must have measurable disease per RECIST v1.1 and be negative for MSI‑H/dMMR and BRAF V600E. The study follows participants for safety and efficacy outcomes such as response rate, progression‑free survival, and overall survival with routine imaging and clinical assessments. Key exclusions include untreated central nervous system metastases, recent other active malignancies, or prior systemic therapy for metastatic disease.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed, previously untreated unresectable or metastatic colorectal adenocarcinoma that is MSS (non‑MSI‑H), BRAF V600E‑negative, measurable by RECIST v1.1, and without untreated CNS metastases.

Not a fit: Patients with MSI‑H/dMMR tumors, BRAF V600E mutations, prior systemic therapy for metastatic disease, untreated brain metastases, or recent other active malignancies are unlikely to qualify or derive benefit from this trial.

Why it matters

Potential benefit: If successful, pumitamig plus chemotherapy could provide better tumor control and longer survival than current bevacizumab‑based first‑line regimens.

How similar studies have performed: Bevacizumab plus chemotherapy is an established first‑line standard for metastatic colorectal cancer, while replacing bevacizumab with a novel agent like pumitamig is experimental—earlier‑phase combinations of targeted agents with chemotherapy have shown encouraging signals but few definitive phase 3 successes to date.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Tucson, Arizona and 278 other locations

+229 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Untreated, Unresectable, or Metastatic Colorectal CancerMetastatic Colorectal Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.