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

Trial 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).

Receptor status / problem studied:

Advanced/metastatic hepatocellular carcinoma (HCC)

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

 

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Open for recruitment

Trial Title

Relativity-106

Diagnosis

Liver cancer

Type of trial

Pharmaceutical

Type of treatement

Medical Oncology

Phase

I/II

Locations

Investigators

Principal Investigator
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