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A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

NCT04039607

Description:

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: CA209-9DW
  • NCT ID: NCT04039607

Conditions

  • Hepatocellular Carcinoma

Interventions

DrugSynonymsArms
NivolumabNivolumab + Ipilimumab
IpilimumabNivolumab + Ipilimumab
SorafenibSorafenib/lenvatinib
lenvatinibSorafenib/lenvatinib

Purpose

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Trial Arms

NameTypeDescriptionInterventions
Nivolumab + IpilimumabExperimental
  • Nivolumab
  • Ipilimumab
Sorafenib/lenvatinibActive Comparator
  • Sorafenib
  • lenvatinib

Eligibility Criteria

        Inclusion Criteria:

          -  Participants must have a diagnosis of HCC based on histological confirmation

          -  Participants must have an advanced HCC

          -  Participants must have at least one Response Evaluation Criteria in Solid Tumors
             (RECIST) 1.1 measurable previously untreated lesion

          -  Child-Pugh score 5 or 6

          -  Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 or 1

        Exclusion Criteria:

          -  Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC

          -  Prior liver transplant

          -  Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12
             months prior to randomization

          -  Active brain metastases or leptomeningeal metastases

        Other protocol inclusion/exclusion criteria may apply.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:Up to 4 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Duration of Response (DOR)
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Time to Symptom Deterioration (TTSD)
Time Frame:Up to 4 years
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bristol-Myers Squibb

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