A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

Completed · Phase 3

Conditions studied: Melanoma

In brief

The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.

Key facts

Study ID

NCT02714218

Run by

Bristol-Myers Squibb

People needed

387

Starts

2016-04-04

Expected to finish

2021-05-28

Last updated by the study team

2022-06-24

Who can join

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

You may qualify if…

• Subject must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma [per American Joint Committee on Cancer (AJCC) staging system] that is unresectable or metastatic
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Subject has not been treated by systemic anticancer therapy for unresectable or metastatic melanoma

You may not qualify if…

• Subjects with active brain metastases or leptomeningeal metastases
• Subjects with ocular melanoma
• Subjects with active, known or suspected autoimmune disease
• Other protocol defined inclusion/exclusion criteria could apply

Where it is running

• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Allina Health — Fridley, Minnesota, United States
• Washington University School Of Medicine — St Louis, Missouri, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States
• University Of Virginia Health System — Charlottesville, Virginia, United States
• University of Washington - Seattle Cancer Care Alliance — Seattle, Washington, United States
• Local Institution — North Sydney, New South Wales, Australia
• Local Institution - 0045 — Waratah, New South Wales, Australia
• Local Institution — Greenslopes, Queensland, Australia
• Local Institution — Melbourne, Victoria, Australia
• Local Institution - 0007 — Edmonton, Alberta, Canada
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• CHU de Quebec - Universite Laval — Québec, Quebec, Canada
• Local Institution - 0063 — Aarhus N, Denmark
• Local Institution - 0065 — Herlev, Denmark
• Local Institution - 0064 — Odense, Denmark
• Hopital Saint Andre — Bordeaux, France
• Chru De Lille — Lille, France
• Hopital De La Timone — Marseille, France
• Hopital Hotel Dieu — Nantes, France
• University Of Colorado Cancer Center — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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