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Active, Not Recruiting

An Investigational Immuno-therapy Study of Nivolumab, and Nivolumab in Combination With Other Anti-cancer Drugs, in Colon Cancer That Has Come Back or Has Spread - CA209-142

Updated: 4 November, 2019   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 2


  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
Experimental: Nivolumab (Nivo) + BMS-986016 Cohort C5
Drug: anti-LAG-3 antibody Drug: Nivolumab
Experimental: Nivolumab (Nivo) + Daratumumab Cohort C6
Drug: Daratumumab Drug: Nivolumab
Experimental: Nivolumab (Nivo) + Ipilimumab (Ipi)
Drug: Nivolumab Drug: Ipilimumab
Experimental: Nivolumab (Nivo) + Ipilimumab (Ipi) + Cobimetinib Cohort C4
Drug: Ipilimumab Drug: Nivolumab Drug: Cobimetinib
Experimental: Nivolumab (Nivo) + Ipilimumab (Ipi) Cohort C3
Drug: Nivolumab Drug: Ipilimumab
Experimental: Nivolumab Monotherapy
Drug: Nivolumab

Key Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Men and women ≥ 18 years of age - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 - Histologically confirmed recurrent or metastatic colorectal cancer - Measurable disease by CT or MRI - Testing for MSI Status (by an accredited lab) 1. 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. 2. 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 - Willing and able to comply with study procedures - Subjects enrolled into the C3 Cohort must have not had treatment for their metastatic disease Exclusion Criteria: - Active brain metastases or leptomeningeal metastases are not allowed. - Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (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 Other protocol defined inclusion/exclusion criteria could apply

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com