Feasibility and Efficacy of Perioperative Nivolumab With or Without Relatlimab for Patients With Potentially Resectable Hepatocellular Carcinoma (HCC)

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT04658147
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab 480mg will be administered as a 30 minute IV infusion (-/+15min) at cycle 1 day 1 and at cycle 2 day 1 (28 days) then every month for up to 12 months. Intravenous administration of Nivolumab (480 mg) will occur on Cycle 1 and 2 of the study then every 28 days up to a year. Nivolumab will be administered on Day 1 of each cycle for 10 doses/ months (whichever occurs first) for adjuvant.
  • Relatlimab — DRUG
    Patients will receive 480 mg Relatlimab intravenously (-/+15min) on cycle 1 day 1 and at cycle 2 day 1 (every 28 days) for up to 1 year co-administered with Nivolumab.

Study Details

The purpose of this study is to determine the safety and tolerability of neoadjuvant/adjuvant Nivolumab or Nivolumab plus Relatlimab in patients with HCC.

Key Dates

Start date
May 28, 2021
Status verified
Jun 2026
Primary completion
Sep 2, 2025
Completion
Jun 1, 2030

Study Design

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

Arms

  • Experimental: Arm A - Nivolumab
    Participants receive Nivolumab only.
  • Experimental: Arm B - Nivolumab and Relatlimab
    Participants receive Nivolumab and Relatlimab.

Primary Outcome Measure

Number of patients who complete pre-op treatment and proceed to surgery [ Time Frame: 4 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-
The Ohio State University, Wexner Medical CenterColumbusOhio43210-1002-

Find similar trials in Baltimore, MD

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Sidney Kimmel Comprehensive Cancer Center· Baltimore, MDThe Ohio State University, Wexner Medical Center· Columbus, OH

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