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Recruitment into this study has closed and is no longer accepting new patients.

Active, Not Recruiting

A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma - CA045-001

Updated: 13 March, 2023   |   ClinicalTrials.gov

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Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 12+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Combination
Biological: NKTR-214 Biological: Nivolumab
Experimental: Monotherapy
Biological: Nivolumab

Key Eligibility Criteria

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

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Side Effects (Adverse Events) and other reportable events are defined here
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