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

NCT03635983

Description:

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

Related Conditions:
  • Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
  • Official 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

Clinical Trial IDs

  • ORG STUDY ID: CA045-001
  • SECONDARY ID: 2018-001423-40
  • SECONDARY ID: 17-214-08
  • NCT ID: NCT03635983

Conditions

  • Melanoma

Interventions

DrugSynonymsArms
NKTR-214Bempegaldesleukin, BMS-986321Combination
NivolumabOpdivo, BMS-936558Combination

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
CombinationExperimentalNKTR-214 + Nivolumab
  • NKTR-214
  • Nivolumab
MonotherapyExperimentalNivolumab
  • Nivolumab

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:12 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate (ORR) by Blinded Independent Central Review (BICR)
Time Frame:Approximately 16 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Clinical benefit rate (CBR)
Time Frame:Approximately 16 months
Safety Issue:
Description:
Measure:Duration of response (DoR)
Time Frame:Approximately 16 months
Safety Issue:
Description:
Measure:Duration of overall complete response (DoCR)
Time Frame:Approximately 16 months
Safety Issue:
Description:
Measure:Time to response (TTR)
Time Frame:Approximately 16 months
Safety Issue:
Description:
Measure:ORR by investigator and in biomarker population
Time Frame:Approximately 16 months
Safety Issue:
Description:
Measure:PFS by investigator and in biomarker population
Time Frame:Approximately 22 months
Safety Issue:
Description:
Measure:OS in biomarker population
Time Frame:Up to 59 months
Safety Issue:
Description:
Measure:Incidence of participants with non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuation
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of treatment-related AEs
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of treatment-related SAEs
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities
Time Frame:Up to 5 years
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

Trial Keywords

  • NKTR-214
  • Nivolumab
  • Immunotherapy

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