臨床研究等提出・公開システム

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

Pumitamig in Combination with Chemotherapy Versus Bevacizumab in Combination
with Chemotherapy in Previously Untreated, Unresectable, or Metastatic Colorectal Cancer (CA2660003)

Jin Lixian

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

mg-jp-clinical_trial@bms.com

Jin Lixian

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

+81-120-093-507

MG-JP-RCO-JRCT@bms.com

Recruiting

Feb. 24, 2026

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

- 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 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.

Both

Untreated, Unresectable, or Metastatic Colorectal Cancer

Experimental: Arm A1
Pumitamig+FOLFOX/FOLFIRI
Experimental: Arm A2
Pumitamig+FOLFOX/FOLFIRI
Other: Arm B
Bevacizumab+FOLFOX/FOLFIRI
Experimental: Arm C
Pumitamig+FOLFOX/FOLFIRI/CAPOX
Other: Arm D
Bevacizumab+FOLFOX/FOLFIRI/CAPOX

Specified dose on specified days

Phase 2:PFS by RECIST v1.1 per investigator assessment
Phase3: Overall Survival (OS), PFS

Phase2: Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment, Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment, Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment

Phase3: OR and DOR by RECIST v1.1 per BICR

+81-3-3520-0111

Feb. 09, 2026

Yes

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Argentina/Australia/Austria/Belgium/Brazil/Canada/Chile/China/Czech Republic/France/Germany/India/Italy/Korea/Netherlands/Poland/Romania/ Singapore/Spain/Sweden/Taiwan/Turkey/United Kingdom/United States