NCT07221357 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
| NCT ID | NCT07221357 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Bristol-Myers Squibb |
| Condition | Untreated, Unresectable, or Metastatic Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 990 participants |
| Start Date | 2025-12-31 |
| Primary Completion | 2030-02-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 990 participants in total. It began in 2025-12-31 with a primary completion date of 2030-02-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 untreated, unresectable, or metastatic colorectal 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, 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.
Contact & Investigator
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
✉ Clinical.Trials@bms.com📞 855-907-3286
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT07221357 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Untreated, Unresectable, or Metastatic Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07221357 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07221357 currently recruiting?
Yes, NCT07221357 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT07221357 trial being conducted?
This trial is being conducted at Tucson, United States, Springdale, United States, La Jolla, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT07221357 clinical trial?
NCT07221357 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 990 participants.
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