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 now · Phase 2/Phase 3

Conditions studied: Untreated, Unresectable, or Metastatic Colorectal Cancer

In brief

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

Key facts

Study ID

NCT07221357

Run by

Bristol-Myers Squibb

People needed

990

Starts

2025-12-31

Expected to finish

2034-03-11

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Texas Oncology - San Antonio — San Antonio, Texas, United States (enrolling)
• Sanford Fargo Medical Center — Fargo, North Dakota, United States (enrolling)
• Sanford Cancer Center — Sioux Falls, South Dakota, United States (enrolling)
• Texas Oncology Dallas Fort Worth West (DFWW) - Arlington Cancer Center North — Arlington, Texas, United States (enrolling)
• Baylor College of Medicine Medical Center — Houston, Texas, United States (enrolling)
• University of California, Irvine (UCI) Health - UC Irvine Medical Center — Orange, California, United States (enrolling)
• New York Cancer and Blood Specialists — Shirley, New York, United States (enrolling)
• The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States (enrolling)
• Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital — Marietta, Georgia, United States (enrolling)
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• Florida Cancer Specialists - East — Cape Coral, Florida, United States (enrolling)
• Texas Oncology, PA — Austin, Texas, United States (enrolling)
• Florida Cancer Specialists - North — St. Petersburg, Florida, United States (enrolling)
• Maryland Oncology Hematology - Silver Spring — Silver Spring, Maryland, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Laura and Isaac Perlmutter Cancer Center at NYU Langone — Mineola, New York, United States (enrolling)
• Highlands Oncology Group — Springdale, Arkansas, United States (enrolling)
• Minnesota Oncology — Maple Grove, Minnesota, United States (enrolling)
• Northside Hospital — Atlanta, Georgia, United States (enrolling)
• Washington University School OF Medicine-Siteman Cancer Center — St Louis, Missouri, United States (enrolling)
• University Of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• Northwell Health/ RJ Zuckerberg Cancer Center — Lake Success, New York, United States (enrolling)
• Virginia Oncology Associates — Norfolk, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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