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

Phase 3

Active, not recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Nivolumab; Drug: Sorafenib; Drug: lenvatinib; Drug: Ipilimumab

• Registration Number: NCT04039607
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-30
• Study First Submitted QC: 2019-07-30
• Study First Posted: 2019-07-31
• Study Start: 2019-09-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-02
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 732

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-defined inclusion/exclusion criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sorafenib/lenvatinib	lenvatinib	-
Nivolumab + Ipilimumab	Nivolumab	-
Sorafenib/lenvatinib	Sorafenib	-
Nivolumab + Ipilimumab	Ipilimumab	-

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to 4 years

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Up to 4 years
Duration of Response (DOR)	Up to 4 years
Time to Symptom Deterioration (TTSD)	Up to 4 years

Trial Locations

Locations (205)

Local Institution - 0292; 🇺🇸 Tucson, Arizona, United States

Local Institution - 0288; 🇺🇸 Coronado, California, United States

Local Institution - 0157; 🇺🇸 Duarte, California, United States

Local Institution - 0077; 🇺🇸 Washington, District of Columbia, United States

Local Institution - 0027; 🇺🇸 Louisville, Kentucky, United States

Local Institution - 0190; 🇺🇸 Baltimore, Maryland, United States

Local Institution; 🇷🇴 Craiova, Romania

Local Institution - 0018; 🇺🇸 Detroit, Michigan, United States

Local Institution - 0295; 🇺🇸 Newark, New Jersey, United States

Local Institution - 0043; 🇺🇸 Toledo, Ohio, United States

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