Adaptive Dosing of Nivolumab and Ipilimumab for Liver Cancer

This study is looking at how to best give two immunotherapy drugs, nivolumab and ipilimumab, to people with hepatocellular carcinoma (HCC), a type of liver cancer. Researchers want to see if adjusting the dose of these drugs based on how well a patient is responding can be effective and safe. You might be able to join if you are 18 or older, have HCC confirmed by a doctor, and haven't received certain prior immunotherapy treatments. The main goal is to see how many people experience disease control after receiving nivolumab and ipilimumab. The study is currently unclear on its recruitment status and plans to enroll 60 participants.

Study design
This is an interventional study with 60 planned participants. It will test an adaptive dosing strategy for immunotherapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your disease control will be measured from the start of treatment until disease progression, unacceptable side effects, death, or leaving the study, for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07689175

Adaptive Dosing of Immune Checkpoint Inhibitors for Hepatocellular Carcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Texas Southwestern Medical Center
~60 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:NivolumabIpilimumab (3 mg/kg)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease control rate after immunotherapy nivolumab plus ipilimumab
Measured over 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
Hepatocellular Carcinoma (HCC)

NCT07689175

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Texas Southwestern Medical Center

    Dallas, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • David Hsieh, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

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Eligibility criteria

Inclusion

Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion

Has evidence of progression by neurologic symptoms
Has metastatic brain lesions that require immediate intervention.
Has carcinomatous meningitis, regardless of clinical stability 8. Known severe hypersensitivity reactions to monoclonal antibodies (≥Grade 3). 9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements. 10. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. 11. Prisoners or subjects who are involuntarily incarcerated. 12. Has significant dementia or other mental condition that precludes the participant's ability to consent to the study.
  • Disease control rate after immunotherapy nivolumab plus ipilimumabFrom time of initial treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months

    To determine the proportion of patients with imaging evidence of subsequent disease control (stable disease, partial response, or complete response); Per RECIST v.1.1. among subjects who attained an initial favorable imaging response.