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

NOT ENROLLING
Protocol # :
18-489
Conditions
Melanoma
Phase
III
Disease Sites
Melanoma, Skin
Principal Investigator
Buchbinder, Elizabeth, I

Trial Description

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

Eligibility Requirements

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 and/or
neoadjuvant treatment for melanoma with approved agents

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 apply

18-489