EUCTR2013-003939-30-IE
Active, not recruiting
Phase 1
A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations, in Recurrent and Metastatic Microsatellite Instability High (MSI-H) and non-MSI-H Colon Cancer - CheckMate 142
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- MSI Positive Colorectal CancerMSI Negative Colorectal Cancer
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 375
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Men and women \= 18 years of age
- •\- ECOG performance status 0 to 1\.
- •\- Histologically confirmed colorectal cancer.
- •\- Measurable disease by CT or MRI.
- •\- Testing for MSI Status
- •a. Subjects with microsatellite instability high (MSI\-H) tumors will enroll
- •in the MSI\-H Cohort (mStage and cStage groups), the C3 Cohort, and the
- •b. Subjects with phenotypes that are non\-microsatellite instability high
- •(non\-MSI\-H) will enroll in the non\- MSI\-H Safety Cohort and the C6, C4
- •\- Adequate organ function as defined by study\-specific laboratory tests
Exclusion Criteria
- •Active brain metastases or leptomeningeal metastases are not allowed.
- •Prior treatment with an anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2, anti\-CTLA\-4 antibody, or any other antibody or drug specifically targeting T\-cell co\-stimulation or immune checkpoint pathways.
- •Prior malignancy active within the previous 3 years except for locally curable cancers
- •Subjects with active, known or suspected autoimmune disease.
- •Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration.
Outcomes
Primary Outcomes
Not specified
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