A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors

Sponsor
Bristol-Myers Squibb
Study ID
NCT04567615
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Relatlimab — BIOLOGICAL
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the effectiveness and safety of relatlimab in combination with nivolumab in participants with advanced liver cancer who have never been treated with immuno-oncology therapy, after prior treatment with tyrosine kinase inhibitor therapy.

Key Dates

Start date
Feb 4, 2021
Status verified
Dec 2025
Primary completion
Aug 31, 2023
Completion
Nov 19, 2025

Study Design

Enrollment
266 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A : Nivolumab
  • Experimental: Arm B : Nivolumab + Relatlimab Dose 1
  • Experimental: Arm C : Nivolumab + Relatlimab Dose 2

Primary Outcome Measure

Objective Response Rate(ORR) Assessed by BICR [ Time Frame: From randomization to primary completion date (Approximately 29.5 Months) ]

Related Studies