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Taking people in FrancePhase 2/3

Tests pumitamig with chemotherapy against bevacizumab in colorectal cancer

Compares pumitamig plus chemotherapy with bevacizumab plus chemotherapy in untreated colorectal cancer.

Key facts

Who runs it
Bristol-Myers Squibb
Where
Besancon Cedex, Dijon, Lille, Limoges Cedex 1, Lorient, Marseille, Nantes, Paris, Pessac, Rouen, Saint-Herblain Cedex, Suresnes, Toulouse, and Villejuif, FranceSee the 15 sitesAlso in 25 other countries, 270 sites
Trial code
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
Status
Recruiting
Phase
Phase 2/3
People taking part
990 people, planned
Started
31 Dec 2025
Expected to end
11 Mar 2034
Type of study
Interventional, 5 groups
Treatments tested
  • Pumitamig
  • FOLFOX
  • FOLFIRI
  • Bevacizumab
  • CAPOX
Record updated
23 October 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in France

Also in 25 other countries, 270 sites

  • CHU BesanconBesancon Cedex, FranceTaking people
  • Centre Hospitalier Universitaire de DijonDijon, FranceTaking people
  • Centre Oscar LambretLille, FranceTaking people
  • Centre Hospitalier Et Universitaire De LimogesLimoges Cedex 1, FranceTaking people
  • Groupe Hospitalier Bretagne SudLorient, FranceTaking people
  • Centre Hospitalier Regional De MarseilleMarseille, FranceTaking people
  • Institut Paoli-CalmettesMarseille, FranceTaking people
  • Centre Hospitalier Universitaire de NantesNantes, FranceTaking people
  • Assistance Publique Hopitaux de ParisParis, FranceTaking people
  • Centre Hospitalier Universitaire de BordeauxPessac, FranceTaking people
  • Centre Hospitalier Universitaire RouenRouen, FranceTaking people
  • Institut De Cancerologie De L OuestSaint-Herblain Cedex, FranceTaking people
  • Hospital FochSuresnes, FranceTaking people
  • Centre Hospitalier Universitaire de ToulouseToulouse, FranceTaking people
  • Institut Gustave RoussyVillejuif, FranceTaking people

About the trial

What the trial wants to find out

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

The 5 groups in the trial

  • Arm A1Treatment being tested

    Treatment: Pumitamig, FOLFOX, and FOLFIRI

  • Arm A2Treatment being tested

    Treatment: Pumitamig, FOLFOX, and FOLFIRI

  • Arm BOther group

    Treatment: FOLFOX, FOLFIRI, and Bevacizumab

  • Arm CTreatment being tested

    Treatment: Pumitamig, FOLFOX, FOLFIRI, and CAPOX

  • Arm DOther group

    Treatment: FOLFOX, FOLFIRI, Bevacizumab, and CAPOX

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests pumitamig with chemotherapy against bevacizumab in colorectal cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
23 October 2026