EUCTR2013-003939-30-BE
Active, not recruiting
Phase 1
A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations, in Recurrent andMetastatic Microsatellite Instability High (MSI-H) and non-MSI-H Colon Cancer - CheckMate 142
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 375
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
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 C5 Cohort.
- •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 Cohorts.
- •Adequate organ function as defined by study\-specific laboratory tests
- •Must use acceptable form of birth control throughout the study. After the final dose of study drug, an acceptable form of birth control must be used for 23 weeks for women of childbearing potential (WOCBP) and 31 weeks for men who are sexually active with WOCBP.
- •Signed informed consent
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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