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Study of Pumitamig with Chemotherapy for Colorectal Cancer

This study is looking at two different treatment approaches for people with colorectal cancer that has not been treated before, or that cannot be removed by surgery or has spread (metastatic). You would receive either pumitamig combined with chemotherapy (FOLFOX, FOLFIRI, or CAPOX), or bevacizumab combined with chemotherapy (FOLFOX, FOLFIRI, or CAPOX). The study aims to see how safe and effective these combinations are. To join, you must have colorectal adenocarcinoma that is recurrent or metastatic and cannot be cured by surgery. You also cannot have mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer. The study will measure how many people respond to treatment, how long people live without their cancer getting worse, and how long people live overall. The current status of this study is unclear.

Study design
This interventional study plans to enroll 990 participants. It compares two different treatment combinations.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to measure treatment response, progression-free survival, and overall survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~990 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:PumitamigFOLFOXFOLFIRIBevacizumabCAPOX

At a glance

Recruiting sites
177 of 285 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Measured over Up to 5 years
+2 more outcomes measured

Conditions

Untreated, Unresectable, or Metastatic Colorectal Cancer

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NCT07221357

Where you'd take part

This study runs at 285 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, Japanstudy coordinator listed

    Recruiting

  • Antwerp University Hospital

    Edegem, Antwerpen, Belgiumstudy coordinator listed

    Recruiting

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, Italystudy coordinator listed

    Recruiting

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], South Koreastudy coordinator listed

    Recruiting

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

    Marseille, Francestudy coordinator listed

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Milano, Italystudy coordinator listed

    Recruiting

  • AZ Delta vzw

    Roeselare, West-Vlaanderen, Belgiumstudy coordinator listed

    Recruiting

  • Azienda Ospedaliera Garibaldi

    Catania, Italystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessmentUp to 5 years

    Phase 2

  • Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)Up to 5 years

    Phase 3

  • Overall Survival (OS)Up to 5 years

    Phase 3