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A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
Not Recruiting
Trial ID: NCT03635983
Purpose
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
Official Title
A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma
Stanford Investigator(s)
Sunil Arani Reddy
Clinical Associate Professor, Medicine - Oncology
Eligibility
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
Intervention(s):
biological: NKTR-214
biological: Nivolumab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Phuong Q Pham
650-725-9810