Status:
COMPLETED
An Investigational Immunotherapy Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Colorectal Cancer That Has Spread
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Ono Pharmaceutical Co. Ltd
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This purpose of this study is to evaluate nivolumab (BMS-936558) in combination with standard of care (SOC) chemotherapy with bevacizumab for the treatment of first-line metastatic colorectal cancer (...
Eligibility Criteria
Inclusion
- Histologically confirmed metastatic colorectal cancer, not amenable to curative resection
- No prior chemotherapy for metastatic colorectal cancer
- ECOG Performance Status of 0-1
- Ability to provide adequate tissue sample
Exclusion
- Patients with clinically relevant medical history, including autoimmune disease, cardiovascular disease, hepatic disease or bleeding disorders
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
February 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2022
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT03414983
Start Date
February 20 2018
End Date
December 28 2022
Last Update
November 18 2023
Active Locations (49)
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1
Uab Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
2
Local Institution - 0004
Los Angeles, California, United States, 90033
3
Local Institution - 0010
Aurora, Colorado, United States, 80045
4
Local Institution - 0027
Denver, Colorado, United States, 80218