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

Completed · Phase 2/Phase 3

Conditions studied: Colorectal Cancer

In brief

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 (mCRC).

Key facts

Study ID

NCT03414983

Run by

Bristol-Myers Squibb

People needed

196

Starts

2018-02-20

Expected to finish

2022-12-28

Last updated by the study team

2023-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Uab Comprehensive Cancer Center — Birmingham, Alabama, United States
• Local Institution - 0004 — Los Angeles, California, United States
• Local Institution - 0010 — Aurora, Colorado, United States
• Local Institution - 0027 — Denver, Colorado, United States
• Local Institution - 0020 — New Haven, Connecticut, United States
• Local Institution - 0039 — Miami, Florida, United States
• Local Institution - 0047 — St. Petersburg, Florida, United States
• Local Institution - 0033 — Arlington Heights, Illinois, United States
• Local Institution - 0044 — Indianapolis, Indiana, United States
• Local Institution - 0021 — Bethesda, Maryland, United States
• Local Institution - 0003 — Boston, Massachusetts, United States
• Local Institution - 0049 — Boston, Massachusetts, United States
• Local Institution - 0052 — Boston, Massachusetts, United States
• Local Institution - 0053 — Boston, Massachusetts, United States
• Local Institution - 0035 — Minneapolis, Minnesota, United States
• Local Institution - 0002 — Rochester, Minnesota, United States
• Local Institution - 0032 — Papillion, Nebraska, United States
• Local Institution - 0029 — Henderson, Nevada, United States
• Local Institution - 0031 — Johnson City, New York, United States
• Local Institution - 0046 — New York, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Local Institution - 0038 — Portland, Oregon, United States
• Local Institution - 0005 — Philadelphia, Pennsylvania, United States
• Local Institution - 0024 — Pittsburgh, Pennsylvania, United States
• Local Institution - 0023 — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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