Cemiplimab +/- Fianlimab Post Y90 Radioembolization in Patients With Hepatocellular Carcinoma

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT07365839
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

Study Details

Randomized, 2-arm, non-comparative, pilot study assessing the efficacy of cemiplimab with or without fianlimab after treatment with yttrium-90 (Y90).

Key Dates

Start date
Jul 1, 2026
Status verified
Mar 2026
Primary completion
Feb 28, 2035
Completion
Feb 28, 2035

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 Treatment with cemiplimab
    350 mg cemiplimab intravenous (IV) every 3 weeks
  • Experimental: Arm 2 Treatment with
    350 mg cemiplimab intravenous (IV) + 1600 mg fianlimab intravenous (IV) every 3 weeks

Primary Outcome Measure

Assess the efficacy of cemiplimab with or without fianlimab as measured by progression-free survival (PFS) [ Time Frame: Baseline, 6, 12, and 18 months, then every 6 months until off study up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23298
Massey CTO GI Team
[email protected]
804-628-6430
Emily Kinsey, MD (PRINCIPAL_INVESTIGATOR)

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