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

NCT03635983Phase 3Completed

Lead sponsor
Bristol-Myers Squibb (Industry)
Enrollment
783 (actual)
Start date
21 Sep 2018
Primary completion
19 Nov 2021 (actual)
Study completion
19 Mar 2024
Last update posted
1 Apr 2025

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
None
Arms
2

Interventions

  • NKTR-214 Biological
  • Nivolumab Biological

Conditions and primary outcome

  • Melanoma

Primary outcome

Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) (From date of randomization to disease progression (Up to 37 months)); Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR) (From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)); Overall Survival (OS) (From date of randomization to date of death (Up to 37 months))

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT03635983 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)

    Time frame
    From date of randomization to disease progression (Up to 37 months)
    Measure
    Number
    Unit
    Percentage of participants

    • Bempegaldesleukin + Nivolumab vs NivolumabSuperiority

      Bempegaldesleukin+Nivolumab over Nivolumab

      Estimate
      0.66Estimate of Odds Ratio (OR)
      95% CI, two-sided
      0.45 to 0.96
      p-value
      0.0311
      Method
      Stratified Cochran-Mantel-Haenszel

  2. Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR)

    Time frame
    From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)
    Measure
    Median
    Unit
    Months

    • Bempegaldesleukin + Nivolumab vs NivolumabSuperiority

      Estimate
      1.09Hazard Ratio (HR)
      95% CI
      0.89 to 1.33
      p-value
      0.3988
      Method
      Log Rank

  3. Overall Survival (OS)

    Time frame
    From date of randomization to date of death (Up to 37 months)
    Measure
    Median
    Unit
    Months

    • Bempegaldesleukin + Nivolumab vs NivolumabSuperiority

      Estimate
      0.94Hazard Ratio (HR)
      95% CI, two-sided
      0.72 to 1.22
      p-value
      0.6361
      Method
      Log Rank

Serious adverse events

Time frame: Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months).

Participants with serious adverse events per group for NCT03635983, as posted
GroupAffectedAt risk
Bempegaldesleukin + Nivolumab161388
Nivolumab172382

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

2 on PubMed

  1. Bempegaldesleukin Plus Nivolumab in Untreated Advanced Melanoma: The Open-Label, Phase III PIVOT IO 001 Trial Results.

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023 Oct 20

    PubMed 37651676 (opens in a new tab)DOI 10.1200/JCO.23.00172 (opens in a new tab)

  2. Bempegaldesleukin plus nivolumab in untreated, unresectable or metastatic melanoma: Phase III PIVOT IO 001 study design.

    Future oncology (London, England) · 2020 Oct

    PubMed 32723187 (opens in a new tab)DOI 10.2217/fon-2020-0351 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.