A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

Completed · Phase 3

Conditions studied: Melanoma

In brief

The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread

Key facts

Study ID

NCT03635983

Run by

Bristol-Myers Squibb

People needed

783

Starts

2018-09-21

Expected to finish

2024-03-19

Last updated by the study team

2025-04-01

Who can join

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

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (adults 18 years or older)/Lansky Performance Score ≥ 80% (minors ages 12-17 only)
• Histologically confirmed stage III (unresectable) or stage IV melanoma
• Treatment-naive participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant and/or neoadjuvant treatment for melanoma with approved agents

You may not qualify if…

• Active brain metastases or leptomeningeal metastases
• Uveal melanoma
• Participants with an active, known or suspected autoimmune disease
• Other protocol defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0014 — La Jolla, California, United States
• Local Institution - 0122 — Stanford, California, United States
• Local Institution - 0051 — Aurora, Colorado, United States
• Local Institution - 0065 — New Haven, Connecticut, United States
• Local Institution - 0153 — Miami, Florida, United States
• Local Institution - 0017 — Miami Beach, Florida, United States
• Local Institution - 0112 — Tampa, Florida, United States
• Local Institution - 0012 — Atlanta, Georgia, United States
• Local Institution - 0019 — Louisville, Kentucky, United States
• Local Institution - 0018 — Boston, Massachusetts, United States
• Local Institution - 0188 — Ann Arbor, Michigan, United States
• Local Institution - 0186 — Fridley, Minnesota, United States
• Local Institution - 0135 — St Louis, Missouri, United States
• Local Institution - 0016 — Hackensack, New Jersey, United States
• Local Institution - 0185 — New Brunswick, New Jersey, United States
• Local Institution - 0141 — New York, New York, United States
• Local Institution - 0037 — Cleveland, Ohio, United States
• Local Institution - 0011 — Portland, Oregon, United States
• Local Institution - 0013 — Portland, Oregon, United States
• St. Luke's Hospital & Health Network — Easton, Pennsylvania, United States
• Local Institution - 0015 — Philadelphia, Pennsylvania, United States
• Local Institution - 0001 — Houston, Texas, United States
• Local Institution - 0064 — Fairfax, Virginia, United States
• Local Institution - 0109 — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• Local Institution - 0187 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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