Pumitamig plus chemotherapy versus bevacizumab plus chemotherapy for untreated metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Highlands Oncology Group
  Springdale, Arkansas, United States Recruiting
• USC/Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• University of California, Irvine (UCI) Health - UC Irvine Medical Center
  Orange, California, United States Recruiting
• California Pacific Medical Center - Pacific Campus
  San Francisco, California, United States Recruiting
• Florida Cancer Specialists - East
  Cape Coral, Florida, United States Recruiting
• Florida Cancer Specialists - North
  St. Petersburg, Florida, United States Recruiting

+236 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.