Status:
RECRUITING
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
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
BioNTech SE
Conditions:
Untreated, Unresectable, or Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 untre...
Eligibility Criteria
Inclusion
- 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, ≥ 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.
Exclusion
Key Trial Info
Start Date :
March 4 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 11 2034
Estimated Enrollment :
990 Patients enrolled
Trial Details
Trial ID
NCT07221357
Start Date
March 4 2026
End Date
March 11 2034
Last Update
December 18 2025
Active Locations (195)
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1
Local Institution - 0263
Los Angeles, California, United States, 90033
2
Local Institution - 0345
Orange, California, United States, 92868
3
Local Institution - 0317
Sacramento, California, United States, 95816
4
Local Institution - 0330
Santa Monica, California, United States, 90404