J2240 - 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 (RELATIVITY-106)
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
I
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Keywords
Contact Us
(410) 955-8964Brief 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).
Eligibility
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:
- Prior ascites that required treatment and requires on-going prophylaxis, or ii) Current ascites requiring treatment
Other protocol-defined inclusion/exclusion criteria apply