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A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma

NCT05625399 · RELATIVITY-127 Phase 3Active, not recruiting

Lead sponsor
Bristol-Myers Squibb (Industry)
Enrollment
579 (actual)
Start date
6 Mar 2023
Primary completion
4 Aug 2025 (actual)
Study completion
18 Nov 2027
Last update posted
26 Aug 2026

Design

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

Interventions

  • Nivolumab + Relatlimab Drug
  • rHuPH20 Drug

Conditions and primary outcome

  • Melanoma

Primary outcome

Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale (Pre-dose (Day 1 to Day 28)); Adjusted Time-Averaged Relatlimab Serum Concentration Over the First 28 Days (Cavgd28-Rela) on Natural Logarithmic Scale (Pre-dose (Day 1 to Day 28)); Adjusted Trough Nivolumab Serum Concentration at Steady-State (Cminss-Nivo) on Natural Logarithmic Scale (Pre-dose (Day 1 to Day 28)); Adjusted Trough Relatlimab Serum Concentration at Steady-State (Cminss-Rela) on Natural Logarithmic Scale (Pre-dose (Day 1 to Day 28))

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT05625399 (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. Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale

    Time frame
    Pre-dose (Day 1 to Day 28)
    Measure
    Mean
    Unit
    ug/mL

    • Nivo + Rela FDC SC vs Nivo + Rela FDC IVNon-inferiority

      Estimate
      0.239Adjusted Mean Difference
      90% CI, two-sided
      0.202 to 0.277
      p-value
      Not given
      Method
      Not given

  2. Adjusted Time-Averaged Relatlimab Serum Concentration Over the First 28 Days (Cavgd28-Rela) on Natural Logarithmic Scale

    Time frame
    Pre-dose (Day 1 to Day 28)
    Measure
    Mean
    Unit
    ug/mL

    • Nivo + Rela FDC SC vs Nivo + Rela FDC IVNon-inferiority

      Estimate
      0.398Adjusted Mean Difference
      90% CI, two-sided
      0.356 to 0.440
      p-value
      Not given
      Method
      Not given

  3. Adjusted Trough Nivolumab Serum Concentration at Steady-State (Cminss-Nivo) on Natural Logarithmic Scale

    Time frame
    Pre-dose (Day 1 to Day 28)
    Measure
    Mean
    Unit
    ug/mL

    • Nivo + Rela FDC SC vs Nivo + Rela FDC IVNon-inferiority

      Estimate
      0.591Adjusted Mean Difference
      90% CI, two-sided
      0.516 to 0.666
      p-value
      Not given
      Method
      Not given

  4. Adjusted Trough Relatlimab Serum Concentration at Steady-State (Cminss-Rela) on Natural Logarithmic Scale

    Time frame
    Pre-dose (Day 1 to Day 28)
    Measure
    Mean
    Unit
    ug/mL

    • Nivo + Rela FDC SC vs Nivo + Rela FDC IVNon-inferiority

      Estimate
      0.998Adjusted Mean Difference
      90% CI, two-sided
      0.880 to 1.116
      p-value
      Not given
      Method
      Not given

Serious adverse events

Time frame: All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).

Participants with serious adverse events per group for RELATIVITY-127, as posted
GroupAffectedAt risk
Nivo + Rela FDC SC143283
Nivo + Rela FDC IV140291

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

No PubMed citation lists NCT05625399.

CT-VCA trial quality

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Data integrity

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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.