Tests pumitamig with chemotherapy against bevacizumab in colorectal cancer
Compares pumitamig plus chemotherapy with bevacizumab plus chemotherapy in untreated colorectal cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Bucharest, Cluj-Napoca, Craiova, Floresti, Iasi, and Iași, RomaniaSee the 7 sites
- Phase
- Phase 2/3
Where in Romania
- Institutul Clinic FundeniBucharest, RomaniaTaking people
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-NapocaCluj-Napoca, RomaniaTaking people
- Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor ClujCluj-Napoca, RomaniaTaking people
- Centrul De Oncologie SF Nectarie S.R.L.Craiova, RomaniaTaking people
- Radiotherapy Center Cluj S.R.L.Floresti, RomaniaTaking people
- Centrul De Oncologie-Euroclinic S.R.L.Iasi, RomaniaTaking people
- Institutul Regional de Oncologie IasiIași, RomaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07221357EU 2025-523224-45-00
- Record updated
- 23 October 2026
- Original description
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 cancerRead full original descriptionShow less
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
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
Inclusion: 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: 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; Participant must not have any untreated known central nervous system (CNS) metastases including brain, leptomeningeal and/or spinal cord compression; Other protocol-defined Inclusion/Exclusion criteria apply.