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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: Recruiting
Phase of Trial: Phase III

Latest Information Update: 22 May 2024

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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

    • 21 May 2024 According to a Bristol-Myers Squibb media release, the US FDA has reassigned a Prescription Drug User Fee Act (PDUFA) goal date of December 29, 2024 for BLA of Subcutaneous Nivolumab Co-Formulated with ENHANZE. The application is based on results from this CheckMate -67T trial.
    • 06 May 2024 According to a Bristol-Myers Squibb media release, company announced the U.S. Food and Drug Administration accepts bristol myers squibbs application for subcutaneous Nivolumab (nivolumab and hyaluronidase). The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 28, 2025. The FDA filing application based on results from CheckMate -67T, the first Phase 3 trial.
    • 23 Feb 2024 Status changed from active, no longer recruiting to recruiting.
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