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Clinical Trial 19754

Cancer Type: Cutaneous
Study Type: Treatment
NCT#: NCT03635983

Phase: Phase III
Prinicipal Investigator:

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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

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

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

Treatments

Therapies

Medications

BMS-936558 (Nivolumab); NKTR-214 (); Nivolumab ()

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

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