A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer (RELATIVITY-106)

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Carcinoma, Hepatocellular

Treatments: Other: Placebo; Drug: Relatlimab; Drug: Bevacizumab; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05337137

CA224-106

U1111-1267-1579 (Other Identifier)

2021-003606-53 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with untreated advanced/metastatic hepatocellular carcinoma (HCC).

Enrollment: 162 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed advanced/metastatic hepatocellular carcinoma (HCC)
• Naïve to systemic therapy for advanced/metastatic HCC (prior neo-adjuvant or adjuvant immunotherapy is permitted if recurrence occurs ≥ 6 months after treatment completion and the case is discussed with BMS medical team)
• Child-Pugh score of 5 or 6 (ie, Child-Pugh A)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria

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

• Prior allogenic stem cell or solid organ transplantation

• Untreated symptomatic central nervous system (CNS) metastases

• Clinically significant ascites as defined by:

  i) Prior ascites that required treatment and requires on-going prophylaxis, or ii) Current ascites requiring treatment

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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162 participants in 2 patient groups

Arm A: Relatlimab + Nivolumab + Bevacizumab

Experimental group

Treatment:

Drug: Nivolumab

Drug: Bevacizumab

Drug: Relatlimab

Arm B: Placebo + Nivolumab + Bevacizumab

Experimental group

Treatment:

Drug: Nivolumab

Drug: Bevacizumab

Other: Placebo