A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma (CheckMate 9DW)

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Ipilimumab; Drug: Sorafenib; Drug: lenvatinib; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04039607

CA209-9DW

Details and patient eligibility

About

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.

Enrollment: 732 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

732 participants in 2 patient groups

Nivolumab + Ipilimumab

Experimental group

Treatment:

Drug: Nivolumab

Drug: Ipilimumab

Sorafenib/lenvatinib

Active Comparator group

Treatment:

Drug: lenvatinib

Drug: Sorafenib