Trial purpose
Cancer treatment
Tumor type
Upper gastrointestinal tract
Age
18+
Trial acronym
RELATIVITY-106
Clinical summary
Summary
Eligible participants will be randomly allocated to either the Experimental Arm or the Placebo Comparator Arm. In the Experimental Arm, participants will receive Relatlimab + Nivolumab + Bevacizumab. In the Placebo Comparator Arm, participants will receive Placebo + Nivolumab + Bevacizumab.
Conditions
This trial is treating patients with liver cancer
Eligibility
Inclusion
- 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
- 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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Bristol-Myers Squibb (BMS)
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
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