ivo versus Nivo/Ipi or versus other chemotherapies to treat colorectal cancer
- Conditions
- Microsatellite Instability High (MSI-H) or Mismatch Repair DeficientMetastatic Colorectal Cancer (dMMR)MedDRA version: 21.0Level: LLTClassification code: 10052362Term: Metastatic colorectal cancer Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-503956-29-00
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 835
Histologically confirmed recurrent or metastatic colorectal cancer (CRC) irrespective of prior treatment history with chemotherapy and/or targeted agents not amenable to surgery (Applicable only during Part 1 enrollment of the study), Histologically confirmed recurrent or metastatic CRC with no prior treatment history with chemotherapy and/or targeted agents for metastatic disease and not amenable to surgery (Applicable during Part 2 enrollment of the study), Known tumor MSI-H or dMMR status per local standard of practice, Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1, Other protocol-defined inclusion/exclusion criteria apply
Participants with an active, known or suspected autoimmune disease, History of interstitial lung disease or pneumonitis, Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method