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A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination with Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants with Advanced Hepatocellular Carcinoma

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Trial Profile

A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination with Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants with Advanced Hepatocellular Carcinoma

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

Latest Information Update: 20 Apr 2025

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At a glance

  • Drugs Ipilimumab (Primary) ; Nivolumab (Primary) ; Lenvatinib; Sorafenib
  • Indications Liver cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms CheckMate 9DW
  • Sponsors Bristol-Myers Squibb

    • Most Recent Events

    • 11 Apr 2025 According to a Bristol Myers Squibb media release, Aiwu Ruth He is a study investigator.
    • 11 Apr 2025 According to a Bristol Myers Squibb media release, the company announced that the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), the most common primary liver cancer. The approval is based on data from this study.
    • 31 Jan 2025 According to a 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) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC), based on results from the Phase 3 CheckMate -9DW trial.

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