A Phase 2 Clinical Trial of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Microsatellite High (MSI-H) Colon CancerRevised Protocol 01 incorporating Protocol amendment 01 - CheckMate 142

Bristol-Myers Squibb International Corporation0 个研究点目标入组 115 人开始时间: 2014年2月28日最近更新: 2015年3月9日

适应症

试验速览

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
•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
•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 46
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 69

•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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