Study Comparing Pumitamig with Chemotherapy to Bevacizumab with Chemotherapy for Untreated, Inoperable, or Advanced Colorectal Cancer
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT07221357
This clinical trial is testing two different treatment combinations for people with colorectal cancer that cannot be removed by surgery or has spread to other parts of the body. The study aims to find out which combination is safer and more effective.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The goal of this study is to compare the safety and effectiveness of two treatment options for colorectal cancer that is either inoperable or has spread. One group of participants will receive a new drug called pumitamig along with chemotherapy, while the other group will receive bevacizumab with chemotherapy. Researchers want to see which combination works better for patients who have not received any prior treatment for their cancer.
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, ≥ 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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0263 | 90033 | Los Angeles | California |
| Local Institution - 0345 | 92868 | Orange | California |
| Local Institution - 0317 | 95816 | Sacramento | California |
| Local Institution - 0330 | 90404 | Santa Monica | California |
| Local Institution - 0293 | 94305 | Stanford | California |
| Local Institution - 0574 | 33990 | Cape Coral | Florida |
| Local Institution - 0575 | 33705 | St. Petersburg | Florida |
| Local Institution - 0269 | 33612 | Tampa | Florida |
| Local Institution - 0276 | 30096 | Duluth | Georgia |
| Local Institution - 0369 | 30060 | Marietta | Georgia |
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