An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma

Completed · Phase 3

Conditions studied: Melanoma

In brief

The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma

Key facts

Study ID

NCT03068455

Run by

Bristol-Myers Squibb

People needed

1844

Starts

2017-04-11

Expected to finish

2021-02-02

Last updated by the study team

2021-09-20

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completely surgically resected stage IIIb/c/d or stage IV melanoma within 12 weeks of participation in study.
• Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work
• No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s) and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for central nervous system (CNS) lesions)

You may not qualify if…

• History of uveal melanoma
• Patients with active, known or suspected autoimmune disease
• Prior treatment with interferon (if complete < 6 months prior to participation in study), anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
• Other protocol defined inclusion/exclusion criteria could apply

Where it is running

• The Angeles Clinic & Research Institute — Los Angeles, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University Of Colorado — Aurora, Colorado, United States
• Georgetown University Med Ctr — Washington D.C., District of Columbia, United States
• Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
• UF Health Cancer Center at Orlando Health — Orlando, Florida, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Winship Cancer Institute — Atlanta, Georgia, United States
• University Of Chicago — Chicago, Illinois, United States
• Northwestern University — Chicago, Illinois, United States
• Oncology Specialists, S.C. — Park Ridge, Illinois, United States
• Mass General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University Of Michigan Health System — Ann Arbor, Michigan, United States
• Virginia Piper Cancer Institute — Minneapolis, Minnesota, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Washington University School Of Medicine — St Louis, Missouri, United States
• NYU Langone Medical Center — New York, New York, United States
• Memorial Sloan Kettering Nassau — New York, New York, United States
• Carolinas Med Ctr — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Providence Cancer Center Oncology And Hematology Care — Portland, Oregon, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Arizona Cancer Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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