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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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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: 01 Oct 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

    • 09 Sep 2024 According to a Bristol Myers Squibb media release, updated efficacy and safety results at approximately 15-months of follow up from this study will be presented at the European Society for Medical Oncology (ESMO) Congress 2024 to be held from September 13-17 in Barcelona, Spain.
    • 21 Jun 2024 According to a Bristol Myers Squibb media release, the EMA has validated the extension application of subcutaneous nivolumab given as solution for injection in a new strength (600 mg/vial) across multiple previously approved adult solid tumor indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab combination therapy, or in combination with chemotherapy or cabozantinib, based on the results from the Phase 3 CheckMate -67T study.
    • 04 Jun 2024 Results of an exploratory analysis assessing health-related quality of life measured using patient-reported outcomes (PROs), FKSI-19 (kidney cancer-related HRQoL) and the EQ-5D-5L (patient's health status) presented at the 60th Annual Meeting of the American Society of Clinical Oncology

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