A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer

Trial number:
NCT05337137
Trial phase:
1, 2
Study type:
Immunotherapy, Targeted therapy
Overall status:
Recruiting

Study start date

May, 2022

Scientific title

A Phase 1/2, Safety Confirmation and Double-blind, Placebo-controlled, Randomized Study of Relatlimab in Combination With Nivolumab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma

Summary

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).

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

Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCCPrior 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

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: Quadruple, Subject masked: Yes, Caregiver masked: Yes, Investigator masked: Yes, Outcomes assessor masked: Yes,

Conditions

Carcinoma, Hepatocellular

Other study ID numbers

CA224-106; 2021-003606-53; U1111-1267-1579

Choose trial site (68)

Farrer Park
Farrer Park Recruiting