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Clinical Trial NCT07221357 for Untreated, Unresectable, or Metastatic Colorectal Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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 Phase 2, Phase 3 990
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
- CA266-0003
- 2025-523224-45 (Other Identifier) (EU CT Number)
- U1111-1325-6505 (Other Identifier) (UTN)
Phase 3
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalArm A1 | Pumitamig Specified dose on specified days FOLFOX Specified dose on specified days FOLFIRI Specified dose on specified days |
ExperimentalArm A2 | Pumitamig Specified dose on specified days FOLFOX Specified dose on specified days FOLFIRI Specified dose on specified days |
OtherArm B | FOLFOX Specified dose on specified days FOLFIRI Specified dose on specified days Bevacizumab Specified dose on specified days |
ExperimentalArm C | Pumitamig Specified dose on specified days FOLFOX Specified dose on specified days FOLFIRI Specified dose on specified days CAPOX Specified dose on specified days |
OtherArm D | FOLFOX Specified dose on specified days FOLFIRI Specified dose on specified days Bevacizumab Specified dose on specified days CAPOX Specified dose on specified days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment | Phase 2 | Up to 5 years |
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR) | Phase 3 | Up to 5 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
PFS by RECIST v1.1 per investigator assessment | Phase 2 | Up to 5 years |
Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment | Phase 2 | Up to 5 years |
Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment | Phase 2 | Up to 5 years |
Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment | Phase 2 | Up to 5 years |
Recommended dose of Pumitamig for Phase 3 | Phase 2 | Up to 5 years |
Overall Survival (OS) | Phase 3 | Up to 5 years |
OR by RECIST v1.1 per BICR | Phase 3 | Up to 5 years |
DOR by RECIST v1.1 per BICR | Phase 3 | Up to 5 years |
- 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.
- 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.
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