ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer
Bristol-Myers Squibb
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 Tumor…
Interventions
- DrugPumitamig
Specified dose on specified days
- DrugFOLFOX
Specified dose on specified days
- DrugFOLFIRI
Specified dose on specified days
- DrugBevacizumab
Specified dose on specified days
- DrugCAPOX
Specified dose on specified days
Locations (279)
- Local Institution - 0428Tucson, Arizona
- Local Institution - 0432Springdale, Arkansas
- Local Institution - 0447La Jolla, California
- USC/Norris Comprehensive Cancer CenterLos Angeles, California
- University of California, Irvine (UCI) Health - UC Irvine Medical CenterOrange, California
- Local Institution - 0317San Francisco, California