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Phase III

A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma

  • Study HIC#:2000023840
  • Last Updated:07/15/2021

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

  • Start Date10/31/2019
  • End Date08/14/2023

Trial Purpose and Description

Primary Outcome Measures  :

  1. Overall response rate (ORR) by Blinded Independent Central Review (BICR) [ Time Frame: Approximately 16 months ]
  2. Progression-free survival (PFS) by BICR [ Time Frame: Approximately 22 months ]
  3. Overall survival (OS) [ Time Frame: Up to 59 months ]

Secondary Outcome Measures  :

  1. Clinical benefit rate (CBR) [ Time Frame: Approximately 16 months ]
  2. Duration of response (DoR) [ Time Frame: Approximately 16 months ]
  3. Duration of overall complete response (DoCR) [ Time Frame: Approximately 16 months ]
  4. Time to response (TTR) [ Time Frame: Approximately 16 months ]
  5. ORR by investigator and in biomarker population [ Time Frame: Approximately 16 months ]
  6. PFS by investigator and in biomarker population [ Time Frame: Approximately 22 months ]
  7. OS in biomarker population [ Time Frame: Up to 59 months ]
  8. Incidence of participants with non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuation [ Time Frame: Up to 5 years ]
  9. Incidence of treatment-related AEs [ Time Frame: Up to 5 years ]
  10. Incidence of treatment-related SAEs [ Time Frame: Up to 5 years ]
  11. Incidence of laboratory abnormalities [ Time Frame: Up to 5 years ]

Eligibility Criteria

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

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