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
- Badalona, Barcelona, Elche, Madrid, Málaga, Pamplona, Salamanca, Santiago de Compostela, and Sevilla, SpainSee the 11 sites
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with colorectal cancer that has not been treated before, has spread or come back, and cannot be removed by surgery meant to remove all of the disease.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Colorectal adenocarcinoma, confirmed by tissue test, that has come back or spread, with no earlier treatment, and not removable by surgery meant to remove all of the disease. Disease must be measurable by RECIST v1.1.
- Earlier treatment
- No earlier treatment for this cancer. No earlier anti-PD-1, anti-PD-L1, anti-PD-L2, CD137 agonist or anti-CTLA-4 antibody, or other drug targeting T cell checkpoint pathways, or chemotherapy.
- Biomarker or test result
- No known mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H) cancer. No known BRAF V600E mutation by local testing.
Main reasons for not taking part
- Untreated brain, leptomeningeal or spinal cord metastases
- Another cancer active in the last 2 years (except low-risk locally curable ones that appear cured)
- Serious heart or blood vessel disease within 6 months before randomization
- Uncontrolled high blood pressure (160 systolic and/or 100 diastolic mm Hg or higher)
- Congenital long QT syndrome
Read by machine on 11 November 2026.
Where in Spain
- Institut Catala d'OncologiaBadalona, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital General Universitario de ElcheElche, SpainTaking people
- Hospital General Universitario Gregorio MarañónMadrid, SpainTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainTaking people
- Hospital Universitario Regional de MálagaMálaga, SpainTaking people
- Hospital Universitario de NavarraPamplona, SpainTaking people
- Complejo Asistencial Universitario de SalamancaSalamanca, SpainTaking people
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpainTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainTaking 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.