ocally Advanced or Metastatic Hepatocellular Carcinoma: Dose Optimization, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab in Subjects Who Have Not Previously Received Systemic Treatment – LIVIGNO-2
- Conditions
- Metastatic Hepatocellular Carcinoma (HCC)Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2023-504600-28-00
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Subjects or their legally authorized representative must voluntarily sign and date an informed consent, approved by an IEC/IRB, prior to the initiation of any screening or study-specific procedures., Subjects with HBV infection will be allowed to enroll if they meet the following criteria: HBV DNA < 500 IU/mL obtained within 35 days prior to initiation of study treatment, eatment for the study duration and for at least 6 months after the last dose of study drug.AND Anti-HBV treatment (per local standard of care) for a minimum of 14 days prior to first dose and willingness to continue tr, Subjects with resolved HBV infection (HBsAg-negative, HBcAb-positive) are eligible if they are willing to comply with HBV DNA monitoring while on study drug and agree to initiate antiviral therapy if HBV DNA becomes detectable (= 10 IU/mL or above the limit of detection). Subjects with a negative HBcAb and positive HBsAb at screening must agree to comply with HBV DNA monitoring if they have no prior history of receiving a complete hepatitis B vaccination series or where locally mandated., No history or current Grade = 3/major immunologic reactions to any IgG-containing agent/mAb., Eligible to enroll:Vitiligo or alopecia. Hypothyroidism stable on hormone rNo active or prior documented history of autoimmune, immune deficiency, or inflammatory disorders including, but not limited to, inflammatory bowel disease, systemic lupus erythematosus, sarcoidosis, Wegener syndrome, rheumatoid arthritis, antiphospholipid antibody syndrome, Guillain-Barre syndrome, or multiple sclerosis. The following are exceptions to this criterion and subjects with these conditions are eleplacement. ·Any chronic skin condition that does not require systemic therapy. ·Celiac disease controlled by diet alone. ·Type 1 diabetes on an insulin regimen. Controlled HIV. Subjects infected with HIV may be enrolled if the following criteria are met: CD4 count is = 100 cells/ tL. (If CD4 count is < 200 cells/ tL, a CD4 to CD8 ratio > 0.4 is required.) Subject has been receiving effective ART for at least 4 weeks with an HIV viral load of less than 200 copies/mL, and subject has no symptomatic AEs higher than Grade 1 attributed to ART., No known active SARS-CoV-2 infection. If a subject has signs/symptoms suggestive of SARS-CoV-2 infection, the subject must have a negative molecular (e.g., PCR) test or 2 negative antigen test results at least 24 hours apart. Note: SARSCoV-2 diagnostic tests should be applied following local requirements/recommendations. mptoms.Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may only rescreen for the study after they meet the following SARS-CoV-2 infection viral clearance criteria: At least 10 days since first positive test result have passed in asymptomatic patients or at least 10 days since recovery, defined as resolution of fever without use of antipyretics and improvement in sy, No history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator., No history of clinically significant conditions within the last 6 months (unless otherwise noted) that in the investigator's opinion, would adversely affect the subject's participation in the study including, but not limited t
For all females of child-bearing potential; a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at C1D1 prior to the first dose of study drug., No history of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins., No known hypersensitivity to Chinese hamster ovary cell products or to any component of the budigalimab or livmoniplimab formulation., Subject must not have been treated with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study., Female subjects of childbearing potential must practice at least 1 protocol-specified method of birth control, that is effective from Study Day 1 through at least 5 months after the last dose of study drug. Persons of non-childbearing potential do not need to use birth control., Female subjects who are not pregnant or breastfeeding, and are not considering becoming pregnant or donating eggs/sperm during the study and for at least 5 months after the last dose of study drug., If male, and subject is sexually active with female partner(s) of childbearing potential, he must agree, from Study Day 1 through 5 months after the last dose of study drug, to practice the protocol-specified contraception., Male who is not considering fathering a child or donating sperm during the study and for approximately 5 months after the last dose of study drug., No treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics are eligible for the study., No current or prior use of immunosuppressive medication within 14 days before the first dose of study drug(s)The following are exceptions to this criterion:Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection).Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent.Steroids as premedication for hypersensitivity reactions (e.g.,CT scan premedication)., No prior therapy with any agent that targets the TGF-ß signaling pathway., No known hypersensitivity to CTLA4 or PD-1/PD-L1 targeting agents.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method