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

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 12 Oct 2017

At a glance

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

    • 22 Sep 2017 Results presented in a Bristol-Myers Squibb media release.
    • 22 Sep 2017 According to a Bristol-Myers Squibb media release, the U.S.FDA has approved Opdivo (nivolumab) injection for intravenous use for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Approval for this indication has been granted under accelerated approval based on tumor response rate and durability of response.
    • 12 Jul 2017 Planned primary completion date changed from 7 Dec 2017 to 22 Jul 2018.
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