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A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of JPB898 (proposed Nivolumab Biosimilar) and US-licensed and EU-authorized Opdivo in Combination with Yervoy in Participants with Untreated Advanced (unresectable/metastatic) Melanoma

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Trial Profile

A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of JPB898 (proposed Nivolumab Biosimilar) and US-licensed and EU-authorized Opdivo in Combination with Yervoy in Participants with Untreated Advanced (unresectable/metastatic) Melanoma

Status: Suspended
Phase of Trial: Phase III

Latest Information Update: 29 Aug 2025

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At a glance

  • Drugs Nivolumab (Primary) ; Ipilimumab; Nivolumab
  • Indications Malignant melanoma
  • Focus Pharmacokinetics; Registrational; Therapeutic Use
  • Sponsors HEXAL; Sandoz

Most Recent Events

  • 07 Aug 2025 Planned End Date changed from 31 Jul 2027 to 1 Feb 2026.
  • 07 Aug 2025 Planned primary completion date changed from 31 Jul 2027 to 1 Feb 2026.
  • 07 Aug 2025 Status changed from recruiting to suspended in light of the evolving regulatory landscape and growing indications that major Health Authorities will move towards a streamlined clinical development, Sandoz took a strategic decision and is winding down its CJPB898A12301 clinical study.

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