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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Untreated, Unresectable, or Metastatic Colorectal Cancer

Treatments: Drug: FOLFIRI; Drug: Bevacizumab; Drug: CAPOX; Drug: Pumitamig; Drug: FOLFOX

Study type: Interventional

Funder types: Industry

Identifiers

NCT07221357

U1111-1325-6505 (Other Identifier)

CA266-0003

2025-523224-45 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 990 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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, ≥ 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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990 participants in 5 patient groups

Arm A1

Experimental group

Treatment:

Drug: FOLFOX

Drug: Pumitamig

Drug: FOLFIRI

Arm A2

Experimental group

Treatment:

Drug: FOLFOX

Drug: Pumitamig

Drug: FOLFIRI

Arm B

Other group

Treatment:

Drug: FOLFOX

Drug: Bevacizumab

Drug: FOLFIRI

Arm C

Experimental group

Treatment:

Drug: FOLFOX

Drug: CAPOX

Drug: Pumitamig

Drug: FOLFIRI

Arm D

Other group

Treatment:

Drug: FOLFOX

Drug: CAPOX

Drug: Bevacizumab

Drug: FOLFIRI