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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Carcinoma, Hepatocellular

In brief

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).

Key facts

Study ID

NCT05337137

Run by

Bristol-Myers Squibb

People needed

83

Starts

2022-05-05

Expected to finish

2025-11-18

Last updated by the study team

2026-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• Local Institution - 0042 — Los Angeles, California, United States
• Local Institution - 0039 — Los Angeles, California, United States
• Local Institution - 0034 — San Francisco, California, United States
• Local Institution - 0030 — Washington D.C., District of Columbia, United States
• Local Institution - 0059 — Baltimore, Maryland, United States
• Local Institution - 0060 — Boston, Massachusetts, United States
• Local Institution - 0065 — Boston, Massachusetts, United States
• Local Institution - 0061 — New York, New York, United States
• Local Institution - 0062 — The Bronx, New York, United States
• Local Institution - 0033 — Milwaukee, Wisconsin, United States
• Local Institution - 0045 — Camperdown, New South Wales, Australia
• Local Institution - 0022 — Adelaide, South Australia, Australia
• Local Institution - 0026 — Heidelberg, Victoria, Australia
• Local Institution - 0013 — Melbourne, Victoria, Australia
• Local Institution - 0017 — Nedlands, Western Australia, Australia
• Local Institution - 0025 — Edmonton, Alberta, Canada
• Local Institution - 0009 — Toronto, Ontario, Canada
• Local Institution - 0064 — Guangzhou, Guangdong, China
• Local Institution - 0066 — Xi'an, Shan3xi, China
• Local Institution - 0021 — Avignon, Cedex 9, France
• Local Institution - 0012 — Grenoble, France
• Local Institution - 0001 — Nice, France
• Local Institution - 0002 — Reims, France
• Local Institution - 0008 — Rennes, France
• Local Institution - 0067 — Madrid, Sede Madrid, Spain

Full record on ClinicalTrials.gov

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