A Study of Nivolumab and Ipilimumab in Combination With Transarterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer

Official Title

A Randomized, Multi-centre, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination With Trans-arterial ChemoEmbolization (TACE) in Patients With Intermediate-stage Hepatocellular Carcinoma (HCC)

Summary:

The purpose of this study is to compare effectiveness and safety of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer

Trial Description

Primary Outcome:

  • Time to TACE progression (TTTP) will be assed by the blinded independent central review (BICR): Arm A versus Arm C
  • Overall Survival (OS): Arm A versus Arm C
Secondary Outcome:
  • Time to TACE progression (TTTP) will be assed by the blinded independent central review (BICR): Arm B versus Arm C
  • Overall Survival (OS): Arm B versus Arm C
  • Event-Free Survival (EFS)
  • Progression-free survival (PFS)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society