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A Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in Participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer

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A Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in Participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer

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

Latest Information Update: 25 Oct 2024

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At a glance

  • Drugs Ipilimumab (Primary) ; Nivolumab (Primary) ; Carboplatin; Cisplatin; Gemcitabine
  • Indications Bladder cancer; Carcinoma; Pelvic cancer; Rectal cancer; Renal cancer; Ureteral neoplasms; Urethral cancer; Urogenital cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms CheckMate901
  • Sponsors Bristol-Myers Squibb; Ono Pharmaceutical

    • Most Recent Events

    • 20 Aug 2024 Planned primary completion date changed from 30 Oct 2024 to 30 Aug 2024.
    • 29 May 2024 According to Bristol Myers Squibb media release, company announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC) based on results of CheckMate -901 trial.
    • 23 May 2024 According to Bristol Myers Squibb media release, the company announced the presentation of data across its oncology and hematology portfolio at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2024 Hybrid Congress.

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