RWF_CA045-001

A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab Versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma

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.
Inclusion Criteria:
•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 treatment

Exclusion Criteria:
•Active brain metastases or leptomeningeal metastases
•Uveal melanoma
•Participants with an active, known or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria could apply
Phase III
NCT03635983
Oncology
Cutaneous (skin)
Brendan Curti, M.D.
BMS (Bristol-Myers Squibb)
Chris Fountain
  • Providence Cancer Institute Franz Clinic