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
- Beijing, Changsha, Chengdu, Chongqing, Fuzhou, Fuzhou Fujian, Guangzhou, Hangzhou, Harbin, Hefei, Jinan, Nanchang, Nanjing, Jiangsu, Nanning, Nanyang, Shanghai, Shenyang, Shenzhen, Taiyuan, Tianjin, Wuhan, and Yangzhou, ChinaSee the 30 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 12 November 2026.
Where in China
- BeijingHospital not named in the registryContact: Site 0409Not yet recruiting
- Changsha, HunanHospital not named in the registryContact: Site 0411Not yet recruiting
- The Third Xiangya Hospital of Central South UniversityChangsha, ChinaContact: Wang Qi, Site 0376Taking people
- Sichuan Cancer HospitalChengdu, ChinaContact: Yongdong Jin, Site 0498Taking people
- Chongqing University Cancer HospitalChongqing, ChinaContact: Jianghong Wang, Site 0499Taking people
- Fuzhou, FujianHospital not named in the registryContact: Site 0354Not yet recruiting
- Fujian Medical University Union HospitalFuzhou Fujian, ChinaContact: Xiaoyan Lin, Site 0388Taking people
- Guangdong Provincial People's HospitalGuangzhou, ChinaContact: Jian Xiao, Site 0414Taking people
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaContact: Ruihua Xu, Site 0130Taking people
- The Sixth Affiliated Hospital of Sun Yat-sen UniversityGuangzhou, ChinaContact: Yanhong Deng, Site 0358Taking people
- Hangzhou, ZhejiangHospital not named in the registryContact: Site 0360Not yet recruiting
- HangzhouHospital not named in the registryContact: Site 0457Not yet recruiting
- Hangzhou, ZhejiangHospital not named in the registryNo longer taking part
- Harbin, HeilongjiangHospital not named in the registryContact: Site 0353Not yet recruiting
- Second Affiliated hospital of Anhui Medical UniversityHefei, ChinaContact: Mingjun Zhang, Site 0595Taking people
- Shandong Cancer HospitalJinan, ChinaContact: Changzheng Li, Site 0382Taking people
- Nanchang, JiangxiHospital not named in the registryContact: Site 0381Not yet recruiting
- Jiangsu Cancer HospitalNanjing, Jiangsu, ChinaContact: Yan Sun, Site 0416Taking people
- Guangxi Medical University Affiliated Tumor HospitalNanning, ChinaContact: Yongqiang Li, Site 0379Taking people
- Nanyang City Center HospitalNanyang, ChinaContact: Lixin Wan, Site 0384Taking people
- Shanghai, Shanghai MunicipalityHospital not named in the registryContact: Site 0378Not yet recruiting
- ShanghaiHospital not named in the registryContact: Site 0356Not yet recruiting
- Shenyang, LiaoningHospital not named in the registryContact: Site 0355Not yet recruiting
- Shenyang, LiaoningHospital not named in the registryNo longer taking part
- Shenzhen, GuangdongHospital not named in the registryContact: Site 0650Not yet recruiting
- First Affiliated Hospital of Shanxi Medical UniversityTaiyuan, ChinaContact: Yusheng Wang, Site 0393Taking people
- Tianjin, HebeiHospital not named in the registryContact: Site 0390Not yet recruiting
- Hubei Cancer HospitalWuhan, ChinaContact: Xinjun Liang, Site 0391Taking people
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaContact: Hongli Liu, Site 0412Taking people
- Northern Jiangsu People's HospitalYangzhou, ChinaContact: Xianwen Zhang, Site 0398Taking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.