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

a study on Liver Cancer Carcinoma Hepatocellular Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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).

Official Title

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

Keywords

Carcinoma, Hepatocellular, Hepatocellular Carcinoma, HCC, Liver Cancer, Relatlimab, Nivolumab, Bevacizumab, First line HCC, Carcinoma, Relatlimab + Nivolumab + Bevacizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California - Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • USC Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT05337137
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 162 study participants
Last Updated