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A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy

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Trial Profile

A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Jun 2025

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At a glance

  • Drugs Nivolumab (Primary) ; Hyaluronidase; Nivolumab
  • Indications Renal cell carcinoma
  • Focus Pharmacokinetics; Registrational
  • Acronyms CheckMate-67T
  • Sponsors Bristol-Myers Squibb

Most Recent Events

  • 11 Jun 2025 Planned End Date changed from 29 Jan 2026 to 10 May 2027.
  • 11 Jun 2025 Planned primary completion date changed from 8 Sep 2025 to 29 Jul 2025.
  • 28 May 2025 According to a Bristol Myers Squibb media release, the European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). The approval by the EC is valid in all 27 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway.

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