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
- Avellino, Aviano, Bari, Castellana Grotte, Catania, La Spezia, Milan, Milano, Naples, Padova, Pisa, Ravenna, Reggio Emilia, San Giovanni Rotondo, and Tricase, ItalySee the 15 sites
- Phase
- Phase 2/3
Where in Italy
- AORN San Giuseppe Moscati AvellinoAvellino, ItalyTaking people
- Centro di Riferimento Oncologico di AvianoAviano, ItalyTaking people
- Istituto Tumori Bari Giovanni Paolo IIBari, ItalyTaking people
- National Institute of Gastroenterology Saverio De Bellis Research HospitalCastellana Grotte, ItalyTaking people
- Presidio Ospedaliero Garibaldi NesimaCatania, ItalyTaking people
- Sant Andrea HospitalLa Spezia, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- IRCCS - Ospedale San RaffaeleMilano, ItalyTaking people
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyTaking people
- Istituto Oncologico VenetoPadova, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
- Azienda Unità Sanitaria Locale della RomagnaRavenna, ItalyTaking people
- Azienda USL IRCCS di Reggio EmiliaReggio Emilia, ItalyTaking people
- Casa Sollievo della SofferenzaSan Giovanni Rotondo, ItalyTaking people
- Pia Fondazione Di Culto E Religione Card G PanicoTricase, ItalyTaking 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.