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

NCT07221357
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Phase
Phase 2/Phase 3
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Recruitment status
Recruiting
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Participants
990
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Lead sponsor
Bristol-Myers Squibb
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Start date
2025-12-31
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Number of sites
283
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Summary
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
clinicaltrials.gov
Short 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
clinicaltrials.gov
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
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2/Phase 3
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Study type
Interventional
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Completion date
2034-03-11
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First posted
2025-10-27
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Registry last updated
2026-08-17
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Primary completion date
2030-02-02
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Start date
2025-12-31
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Participants
990
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Participant count basis
Estimated
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Planned participants
990
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Protocol amendments
1
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Number of sites
283
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Bristol-Myers Squibb
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07221357
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ClinicalTrials.gov ID
NCT07221357
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment

    Timeframe: Up to 5 years

    Phase 2

  2. Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)

    Timeframe: Up to 5 years

    Phase 3

  3. Overall Survival (OS)

    Timeframe: Up to 5 years

    Phase 3

  1. PFS by RECIST v1.1 per investigator assessment

    Timeframe: Up to 5 years

    Phase 2

  2. Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment

    Timeframe: Up to 5 years

    Phase 2

  3. Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment

    Timeframe: Up to 5 years

    Phase 2

  4. Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment

    Timeframe: Up to 5 years

    Phase 2

  5. Recommended dose of Pumitamig for Phase 3

    Timeframe: Up to 5 years

    Phase 2

  6. OR by RECIST v1.1 per BICR

    Timeframe: Up to 5 years

    Phase 3

  7. DOR by RECIST v1.1 per BICR

    Timeframe: Up to 5 years

    Phase 3

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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, 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.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
Sources for eligibility
clinicaltrials.gov

  • Local Institution - 0428Tucson, United StatesNot yet recruiting
  • Highlands Oncology GroupSpringdale, United StatesRecruiting
  • USC/Norris Comprehensive Cancer CenterLos Angeles, United StatesRecruiting
  • Local Institution - 0330Los Angeles, United StatesWithdrawn
  • University of California, Irvine (UCI) Health - UC Irvine Medical CenterOrange, United StatesRecruiting
  • Local Institution - 0317San Francisco, United StatesNot yet recruiting
  • Florida Cancer Specialists - EastCape Coral, United StatesRecruiting
  • Florida Cancer Specialists - NorthSt. Petersburg, United StatesRecruiting
  • Moffitt Cancer CenterTampa, United StatesRecruiting
  • Local Institution - 0326Atlanta, United StatesNot yet recruiting
  • Northside HospitalAtlanta, United StatesRecruiting
  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb HospitalMarietta, United StatesRecruiting
  • Local Institution - 0433Chicago, United StatesNot yet recruiting
  • Local Institution - 0638Fort Wayne, United StatesNot yet recruiting
  • Local Institution - 0335Iowa City, United StatesNot yet recruiting
  • Local Institution - 0262Baltimore, United StatesNot yet recruiting
  • Maryland Oncology Hematology - Silver SpringSilver Spring, United StatesRecruiting
  • Local Institution - 0471Boston, United StatesWithdrawn
  • Local Institution - 0430Ann Arbor, United StatesNot yet recruiting
  • Local Institution - 0254Grand Rapids, United StatesNot yet recruiting
  • Minnesota OncologyMaple Grove, United StatesRecruiting
  • Local Institution - 0318Kansas City, United StatesNot yet recruiting
  • Washington University School OF Medicine-Siteman Cancer CenterSt Louis, United StatesRecruiting
  • University Of Nebraska Medical CenterOmaha, United StatesRecruiting
  • Northwell Health/ RJ Zuckerberg Cancer CenterLake Success, United StatesRecruiting

And 258 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • U1111-1325-6505
  • 2025-523224-45
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (1)