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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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Trial Profile

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: 17 May 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

    • 26 Apr 2024 According to Bristol Myers Squibb media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.The final EC decision is expected in June 2024.
    • 09 Apr 2024 Planned primary completion date changed from 1 Apr 2024 to 30 Oct 2024.
    • 07 Mar 2024 According to Bristol-Myers Squibb media release, the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.
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