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

Bristol-Myers Squibb International Corporation0 个研究点目标入组 375 人开始时间: 2014年2月6日最近更新: 2024年8月5日

研究概览

暂无简介。

•- 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
•- 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
•- Willing and able to comply with study procedures
•- Subjects enrolled into the C3 Cohort must have not had treatment for their metastatic disease
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 259
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 116

•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.

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