> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-safety-and-efficacy-of-pumitamig-in-5d540912-21cf-4df0-8651-2d25b078a733 > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) Participants 990 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) Lead sponsor Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) Start date 2025-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) Number of sites 283 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) ## Dates **Completion date** 2034-03-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) **First posted** 2025-10-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) **Registry last updated** 2026-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) **Primary completion date** 2030-02-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) **Start date** 2025-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) ## Size and sites **Participants** 990 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) **Planned participants** 990 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) **Number of sites** 283 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) **Lead sponsor** Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) ## Identifiers **Registry ID** NCT07221357 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) **ClinicalTrials.gov ID** NCT07221357 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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 criteria - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) ## References - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.bmsclinicaltrials.com) Source: [www.bmsclinicaltrials.com](https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT07221357.html) ### Other registry identifiers (3) - 2025 - U1111-1325-6505 - 2025-523224-45 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07221357) ## Related records ### Drugs (2) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Mescaline](https://trialight.com/data/asset/mescaline-bc193405-4b6d-435d-acbf-612e7292826a.md) ### Collaborators (1) - [BioNTech SE](https://trialight.com/data/company/biontech-se-85cb6dcc-6a40-467f-aab1-af1123099f83.md) ### Lead sponsors (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) ### Conditions (1) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) ### Targets (1) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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