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

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

Summary:

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

Trial Description

Primary Outcome:

• Overall response rate (ORR) by Blinded Independent Central Review (BICR)
• Progression-free survival (PFS) by BICR
• Overall survival (OS)

• Clinical benefit rate (CBR)
• Duration of response (DoR)
• Duration of overall complete response (DoCR)
• Time to response (TTR)
• ORR by investigator and in biomarker population
• PFS by investigator and in biomarker population
• OS in biomarker population
• Incidence of participants with non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuation
• Incidence of treatment-related AEs
• Incidence of treatment-related SAEs
• Incidence of laboratory abnormalities

View this trial on ClinicalTrials.gov