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

• Status: Active, not recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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 (mCRC).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborators: ONO Pharmaceutical Co.; Ono Pharmaceutical Co. Ltd
• Treatments: Bevacizumab; Fluorouracil; Leucovorin; Nivolumab; Oxaliplatin

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• 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 Criteria:

• 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