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OncoMatch/Clinical Trials/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

Is NCT07221357 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2/3 trial studies multiple treatments for untreated, unresectable, or metastatic colorectal cancer.

Phase 2/3RecruitingBristol-Myers SquibbNCT07221357Data as of Sep 2026Location: International · 27 countries

Treatment: Pumitamig · FOLFOX · FOLFIRI · Bevacizumab · CAPOXThe 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

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Bevacizumab

Other

PumitamigFOLFOXFOLFIRICAPOX

Cancer type

Colorectal Cancer

Biomarker criteria

Required: BRAF v600e

no known presence of the gene that encodes the protein B-Raf (BRAF) V600E mutation per local testing

Required: Mismatch-repair proficient (pMMR / MSS)

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)

Disease stage

Metastatic disease required

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy or chemotherapy

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

Lab requirements

Cardiac function

No 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

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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Local Institution - 0428 · Tucson, Arizona
  • Highlands Oncology Group · Springdale, Arkansas
  • Local Institution - 0447 · La Jolla, California
  • USC/Norris Comprehensive Cancer Center · Los Angeles, California
  • University of California, Irvine (UCI) Health - UC Irvine Medical Center · Orange, California

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT07221357 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require MLH1?

Yes, MLH1 wild-type is a required biomarker for enrollment.

Does this trial require MSH2?

Yes, MSH2 wild-type is a required biomarker for enrollment.

Does this trial require MSH6?

Yes, MSH6 wild-type is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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