Adaptive Dosing of Immune Checkpoint Inhibitors for Hepatocellular Carcinoma

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• Patient must have a diagnosis confirmed by histology or clinically by the American Association for the Study of Liver Diseases (AASLD) criteria in patients with cirrhosis. Known fibrolamellar HCC or combined HCC-cholangiocarcinoma will be excluded.
• Patients may not have received any prior anti-PD-1/L1 or anti-CTLA-4 therapies for the treatment of advanced HCC.
• Patients with locally advanced or metastatic disease must have disease deemed not amenable to surgical and/or locoregional therapies or patients who have progressed following surgical and/or locoregional therapies.
• Child-Pugh Score B7-8
• Measurable disease, as defined as lesions that can accurately be measured in at least one dimension according to RECIST v.1.1.
• Prior locoregional therapy is allowed provided the target lesion has increased in size ≥25% since the cessation of locoregional therapy or the target lesion was not treated with locoregional therapy. Patients treated with palliative radiotherapy for symptoms will be eligible as long as the target lesion is not the treated lesion.
• Age ≥ 18 years.
• ECOG performance score 0-2
• Adequate organ and marrow function as defined below:
• Platelet count ≥ 40,000/mm3
• Hgb ≥ 8 g/dl
• INR ≤ 2
• AST, ALT ≤ 5 times ULN
• Calculated creatinine clearance (CrCl) ≥ 35 mL/min. CrCl can be calculated using the Cockcroft-Gault method.
• Albumin ≥ 2.0 g/dl
• All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 120 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• 10a. A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• 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).
• Ability to understand and the willingness to sign a written informed consent.

You cannot join if

• Prior solid organ transplant.
• Hypersensitivity to IV contrast; not suitable for pre-medication.
• Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
• Active autoimmune disease that requires current systemic treatment (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for conditions that, in the investigator's opinion, do not have a substantial hazardous risk such as asthma, and cutaneous and musculoskeletal rheumatologic conditions.
• Known human immunodeficiency virus infection (testing not required) in a patient not on antiretroviral therapy and detectable viral load.
• Prior malignancy that required systemic treatment within the previous year except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer. Preneoplastic or malignant diagnoses that are indolent in nature and do not require active systemic treatment are not excluded.
• If a participant has symptomatic or clinically active brain metastases including leptomeningeal disease, they must be excluded if:
• Has evidence of progression by neurologic symptoms
• Has metastatic brain lesions that require immediate intervention.
• Has carcinomatous meningitis, regardless of clinical stability
• Known severe hypersensitivity reactions to monoclonal antibodies (≥Grade 3).
• 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.
• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
• Prisoners or subjects who are involuntarily incarcerated.
• Has significant dementia or other mental condition that precludes the participant's ability to consent to the study.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

nivolumab. A fully human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed death-1 (PD-1, PCD-1) with immune checkpoint inhibitory and antineoplastic activities. Upon administration, nivolumab binds to and blocks the activation of PD-1, an immunoglobulin superfamily (IgSF) transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), which is overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on antigen-presenting cells (APCs). This results in the activation of T cells and cell-mediated immune responses against tumor cells. Activated PD-1 negatively regulates T-cell activation and plays a key role in tumor evasion from host immunity. NCI Drug Dictionary

ipilimumab. A recombinant human immunoglobulin (Ig) G1 monoclonal antibody directed against the human T-cell receptor cytotoxic T-lymphocyte-associated antigen 4 (CTLA4), with immune checkpoint inhibitory and antineoplastic activities. Ipilimumab binds to CTLA4 expressed on T cells and inhibits the CTLA4-mediated downregulation of T-cell activation. This leads to a cytotoxic T-lymphocyte (CTL)-mediated immune response against cancer cells. CTLA4, an inhibitory receptor and member of the immunoglobulin superfamily, plays a key role in the downregulation of the immune system. NCI Drug Dictionary

Treatments listed in the registry

• 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.

Na · Single Group · masking: None

Main goals

• Disease control rate after immunotherapy nivolumab plus ipilimumab (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)

Other goals

• Overall response rate of combination nivolumab plus ipilimumab
• Favorable response rate combination immunotherapy nivolumab plus ipilimumab
• Objective response rate of combination immunotherapy nivolumab plus ipilimumab
• Progression-free survival of combination immunotherapy nivolumab plus ipilimumab
• Overall survival to immunotherapy nivolumab plus ipilimumab
• Number of participants with Adverse Events (AEs) (serious / non-serious) as defined by CTCAE v5.0

Planned enrollment: 60 (estimated).

• University of Texas Southwestern Medical Center, Dallas, Texas

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07689175
• NCI Drug Dictionary: C68814
• NCI Drug Dictionary: C2654

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 24, 2026. Public record; not medical advice.