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NCT Number: NCT07221357

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

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

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Británico de Buenos Aires, CABA, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pumitamig

Drug

Specified dose on specified days

Other names: BMS-986545, BNT327, PM8002

FOLFOX

Drug

Specified dose on specified days

FOLFIRI

Drug

Specified dose on specified days

Bevacizumab

Drug

Specified dose on specified days

Capox

Drug

Specified dose on specified days

Primary outcomes

  1. Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment

    Time frame: Up to 5 years

    Phase 2

  2. Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)

    Time frame: Up to 5 years

    Phase 3

  3. Overall Survival (OS)

    Time frame: Up to 5 years

    Phase 3

Secondary outcomes

  1. PFS by RECIST v1.1 per investigator assessment

    Time frame: Up to 5 years

    Phase 2

  2. Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment

    Time frame: Up to 5 years

    Phase 2

  3. Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment

    Time frame: Up to 5 years

    Phase 2

  4. 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

    Phase 2

  5. Recommended dose of Pumitamig for Phase 3

    Time frame: Up to 5 years

    Phase 2

  6. OR by RECIST v1.1 per BICR

    Time frame: Up to 5 years

    Phase 3

  7. DOR by RECIST v1.1 per BICR

    Time frame: Up to 5 years

    Phase 3

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • BioNTech SE

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2030
Study completion
2034
First posted
Oct 27, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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