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Not Yet Recruiting

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

Updated: 10 September, 2018   |   ClinicalTrials.gov

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the trial guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 12+

    Age Range

  • 41

    Location(s)

  • Not Yet Recruiting

Treatment Options

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

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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

Have questions? Call 855-907-3286 or Email Us

Have questions?
Call 855-907-3286 or Email Us