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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Other protocol-defined inclusion/exclusion criteria apply

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Relatlimab + Nivolumab + Bevacizumab
  • Drug: Relatlimab
    Specified dose on specified days
    Other names:
    • BMS-986016
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558
    • Opdivo
  • Drug: Bevacizumab
    Specified dose on specified days
    Other names:
    • Avastin
Experimental
Arm B: Placebo + Nivolumab + Bevacizumab
  • Drug: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558
    • Opdivo
  • Drug: Bevacizumab
    Specified dose on specified days
    Other names:
    • Avastin
  • Other: Placebo
    Specified dose on specified days

Recruiting Locations

Harvard Medical School - Massachusetts General Hospital MGH - Cancer Center
Boston, Massachusetts 02114
Contact:
Elizabeth Walsh, Site 0060

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.