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Clinical Trial 19754

Cancer Type: Cutaneous
Interventions:BMS-936558 (Nivolumab); NKTR-214; Nivolumab

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Nikhil Khushalani

Call 813-745-6100
or 1-800-679-0775
Overview

Study 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

Objective

To compare the objective response rate (ORR) using RECIST 1.1 of NKTR-214 combined with nivolumab and that of nivolumab monotherapy in participants with previously untreated unresectable or metastatic melanoma

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