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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

NCT07221357

RecruitingPhase 2, Phase 3

Sponsor: Bristol-Myers Squibb

Conditions: Untreated, Unresectable, or Metastatic Colorectal Cancer

Interventions: Pumitamig, FOLFOX, FOLFIRI, Bevacizumab, CAPOX

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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, 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.

Locations (281)

Tucson, Arizona, United States
Springdale, Arkansas, United States
Los Angeles, California, United States
Orange, California, United States
San Francisco, California, United States
Santa Monica, California, United States
Cape Coral, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Fort Wayne, Indiana, United States
Iowa City, Iowa, United States
Baltimore, Maryland, United States
Silver Spring, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Grand Rapids, Michigan, United States
Maple Grove, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Lake Success, New York, United States
Mineola, New York, United States
Shirley, New York, United States
Charlotte, North Carolina, United States
Fargo, North Dakota, United States
Columbus, Ohio, United States
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