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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

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: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 11 Nov 2019

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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
  • Most Recent Events

    • 11 Nov 2019 According to a Bristol-Myers Squibb Media Release, the U.S. Food and Drug Administration (FDA) has accepted supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. The FDA granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of March 10, 2020. This application is based on data from the Opd
    • 25 Oct 2019 Planned End Date changed from 26 Dec 2019 to 9 Jul 2021.
    • 06 Jun 2019 Results (data cut off: March 2018; n=267) assessing safety and efficacy of nivolumab in the Asian cohort versus those of the broader intent-to-treat (ITT) of CheckMate040 published in the Journal of Hepatology
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