Adaptive Dosing of Immune Checkpoint Inhibitors for Hepatocellular Carcinoma

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07689175
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab 1 mg/kg every 3 weeks for a maximum of 4 doses as part of combination therapy; then 240 mg every 2 weeks or 480 mg every 4 weeks as single agent.
  • Ipilimumab (3 mg/kg) — DRUG
    ipilimumab 3 mg/kg for a maximum of 4 doses as part of combination therapy, for a maximum of 4 doses.

Study Details

The goal of this clinical trial is to learn if immunotherapy including nivolumab plus ipilimumab is effective and safe in treating hepatocellular carcinoma.

Key Dates

First listed
Jul 8, 2026
Start date
Oct 31, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2031
Completion
Oct 31, 2032

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab plus ipilimumab
    Administration: * Route: Intravenous (IV) infusion only. * Schedule and Dose: * Cycles 1-4: Nivolumab 1 mg/kg IV every 3 weeks Ipilimumab 3 mg/kg mg IV every 3 weeks o Subsequent cycles: Nivolumab 480 mg IV every 4 weeks

Primary Outcome Measure

Disease control rate after immunotherapy nivolumab plus ipilimumab [ Time Frame: From time of initial treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
Carrie Manwaring, BS
[email protected]
214-648-7097
David Hsieh, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Texas Southwestern Medical Center· Dallas, TX

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