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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

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: 06 Aug 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 Jul 2025 According to Ono Pharmaceutical media release, the company has received the additional approval of Opdivo(nivolumab) Intravenous Infusion (Opdivo), an anti-PD-1 antibody, on July 10 from the Ministry of Food and Drug Safety (MFDS) in South Korea, for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma. This approval is based on the results from the CheckMate -9DW study.
  • 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.

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