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Studies

Interventional Active not recruiting Phase 3

NCT05625399 on ClinicalTrials.gov

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

Official title: A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma

  • Sponsor: Bristol-Myers Squibb (United Kingdom)
  • Collaborators: Halozyme Therapeutics
  • Enrollment: 579 (Actual)
  • Study start: 2023-03-06 (Actual)
  • Primary completion: 2025-08-04 (Actual)
  • Study completion: 2027-11-18 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

Conditions

  • Melanoma

Intervention / Treatment

  • Drug: Nivolumab + Relatlimab
  • Drug: rHuPH20

Primary Outcome Measures

  • Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale (Pre-dose (Day 1 to Day 28))
    Blood samples were collected to assess serum concentration.
  • Adjusted Time-Averaged Relatlimab Serum Concentration Over the First 28 Days (Cavgd28-Rela) on Natural Logarithmic Scale (Pre-dose (Day 1 to Day 28))
    Blood samples were collected to assess serum concentration.
  • Adjusted Trough Nivolumab Serum Concentration at Steady-State (Cminss-Nivo) on Natural Logarithmic Scale (Pre-dose (Day 1 to Day 28))
    Blood samples were collected to assess serum concentration.
  • Adjusted Trough Relatlimab Serum Concentration at Steady-State (Cminss-Rela) on Natural Logarithmic Scale (Pre-dose (Day 1 to Day 28))
    Blood samples were collected to assess serum concentration.

Countries

Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Finland, France, Germany, Israel, Italy, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, United States

Locations and Investigators

  • Local Institution - 0125, Phoenix, United States
  • Local Institution - 0189, Springdale, United States
  • Local Institution - 0098, Los Angeles, United States
  • Local Institution - 0093, Orange, United States
  • Local Institution - 0123, Stanford, United States
  • Local Institution - 0113, Englewood, United States
  • Local Institution - 0114, Jacksonville, United States
  • Local Institution - 0146, Baltimore, United States
  • Local Institution - 0071, Rochester, United States
  • Local Institution - 0013, Omaha, United States
  • Local Institution - 0169, Cleveland, United States
  • Local Institution - 0139, Easton, United States
  • Local Institution - 0124, Philadelphia, United States
  • Local Institution - 0122, Murray, United States
  • Local Institution - 0115, Fairfax, United States
  • Local Institution - 0050, Coffs Harbour, Australia
  • Local Institution - 0175, Orange, Australia
  • Local Institution - 0172, Port Macquarie, Australia
  • Local Institution - 0118, Wagga Wagga, Australia
  • Local Institution - 0184, Waratah, Australia
  • Local Institution - 0033, Westmead, Australia
  • Local Institution - 0055, Wollstonecraft, Australia
  • Local Institution - 0090, Birtinya, Australia
  • Local Institution - 0008, Bendigo, Australia
  • Local Institution - 0059, Box Hill, Australia
  • Local Institution - 0154, Heidelberg, Australia
  • Local Institution - 0030, Melbourne, Australia
  • Local Institution - 0109, Traralgon, Australia
  • Local Institution - 0106, Nedlands, Australia
  • Local Institution - 0161, Nedlands, Australia
  • Local Institution - 0027, Graz, Austria
  • Local Institution - 0029, Salzburg, Austria
  • Local Institution - 0168, Sankt Pölten, Austria
  • Local Institution - 0037, Vienna, Austria
  • Local Institution - 0072, Brussels, Belgium
  • Local Institution - 0078, Charleroi, Belgium
  • Local Institution - 0016, Liège, Belgium
  • Local Institution - 0177, Fortaleza, Brazil
  • Local Institution - 0180, Vitória, Brazil
  • Local Institution - 0107, Belo Horizonte, Brazil
  • Local Institution - 0110, Rio de Janeiro, Brazil
  • Local Institution - 0025, Ijuí, Brazil
  • Local Institution - 0031, Porto Alegre, Brazil
  • Local Institution - 0058, Porto Alegre, Brazil
  • Local Institution - 0002, Porto Alegrelegre, Brazil
  • Local Institution - 0159, Blumenau, Brazil
  • Local Institution - 0009, Barretos, Brazil
  • Local Institution - 0018, São José do Rio Preto, Brazil
  • Local Institution - 0130, São Paulo, Brazil
  • Local Institution - 0141, Calgary, Canada

And 99 other sites.

Study Officials

  • Bristol-Myers Squibb (Study Director) — Bristol-Myers Squibb