Study to evaluate the safety and efficacy of nivolumab combined with ipilimumab as first-line (1L) therapy for participants with advanced HCC

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, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000252-34-PL

Enrollment

650

Registered

2019-10-22

Start date

2019-12-16

Completion date

Unknown

Last updated

2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma MedDRA version: 21.1 Level: LLT Classification code 10049010 Term: Carcinoma hepatocellular System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10073071 Term: Hepatocellular carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Opdivo (100 mg/10 ml) Product Name: NIVOLUMAB - 10ml vial-COMMERCIAL Product Code: BMS-936558 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: NIVOLUMAB CAS

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 550 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: To compare the ORR [as assessed by BICR based on RECIST 1.1] of nivolumab plus ipilimumab to SOC (sorafenib or lenvatinib) in all randomized participants with advanced HCC who have not received prior systemic therapy. To evaluate DOR [as assessed by BICR based on RECIST 1.1] of nivolumab plus ipilimumab and SOC (sorafenib or lenvatinib) in all randomized participants with advanced HCC who have not received prior systemic therapy. To compare the cancer-related symptom burden for participants randomized to nivolumab plus ipilimumab or SOC [sorafenib or lenvatinib]). ;Primary end point(s): - OS, defined as the time between the date of randomization and the date of death (by any cause). ;Timepoint(s) of evaluation of this end point: During treatment and post treatment follow up until death or lost of follow up	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: To compare the ORR [as assessed by BICR based on RECIST 1.1] of nivolumab plus ipilimumab to SOC (sorafenib or lenvatinib) in all randomized participants with advanced HCC who have not received prior systemic therapy. To evaluate DOR [as assessed by BICR based on RECIST 1.1] of nivolumab plus ipilimumab and SOC (sorafenib or lenvatinib) in all randomized participants with advanced HCC who have not received prior systemic therapy. To compare the cancer-related symptom burden for participants randomized to nivolumab plus ipilimumab or SOC [sorafenib or lenvatinib]). ;Primary end point(s): - OS, defined as the time between the date of randomization and the date of death (by any cause). ;Timepoint(s) of evaluation of this end point: During treatment and post treatment follow up until death or lost of follow up

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Secondary

Measure	Time frame
Secondary end point(s): - ORR, defined as the percentage of participants whose BOR is either a confirmed CR or PR. - DOR, defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression or death due to any cause, whichever occurs first - TTSD, defined as the time from randomization until a clinically meaningful decline in the HCS subscale score of the FACT-Hep. - PFS, defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. - TTP, defined as the time from randomization to the first documented disease progression;Timepoint(s) of evaluation of this end point: Incidence of AEs, SAEs, deaths and laboratory abnormalities in all treated participants	—

Measure

Time frame

Secondary end point(s): - ORR, defined as the percentage of participants whose BOR is either a confirmed CR or PR. - DOR, defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression or death due to any cause, whichever occurs first - TTSD, defined as the time from randomization until a clinically meaningful decline in the HCS subscale score of the FACT-Hep. - PFS, defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. - TTP, defined as the time from randomization to the first documented disease progression;Timepoint(s) of evaluation of this end point: Incidence of AEs, SAEs, deaths and laboratory abnormalities in all treated participants

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, New Zealand, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Spain, Switzerland, Taiwan, United Kingdom, United States

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026