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A Phase 1/2, Dose-escalation, Open-label, Non-comparative Study of Nivolumab or Nivolumab in Combination With Ipilimumab in Advanced Hepatocellular Carcinoma Subjects With or Without Chronic Viral Hepatitis; and a Randomized, Open-label Study of Nivolumab vs Sorafenib in Advanced Hepatocellular Carcinoma Subjects Who Are Naive to Systemic Therapy

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Trial Profile

A Phase 1/2, Dose-escalation, Open-label, Non-comparative Study of Nivolumab or Nivolumab in Combination With Ipilimumab in Advanced Hepatocellular Carcinoma Subjects With or Without Chronic Viral Hepatitis; and a Randomized, Open-label Study of Nivolumab vs Sorafenib in Advanced Hepatocellular Carcinoma Subjects Who Are Naive to Systemic Therapy

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 22 Nov 2024

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At a glance

  • Drugs Cabozantinib (Primary) ; Ipilimumab (Primary) ; Nivolumab (Primary) ; Sorafenib (Primary)
  • Indications Liver cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms Anti-PD-1 HCC; CheckMate 040
  • Sponsors Bristol-Myers Squibb; Ono Pharmaceutical

    • Most Recent Events

    • 19 Nov 2024 Status changed from active, no longer recruiting to completed.
    • 25 Dec 2023 Results of 5-year follow-up , published in the Annals of Oncology
    • 22 Mar 2023 According to Ono Pharmaceutical Co., Ltd. media release, Based on results of Opdivo + Yervoy cohort from this trial, company received approval of Opdivo Intravenous Infusion, in combination with Yervoy on March 21, 2023 in Taiwan from the Taiwan Food and Drug Administration (TFDA), for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib.

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