Safety and Immunotherapeutic Activity of Cemiplimab in Participants With HBV on Suppressive Antiviral Therapy

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Hepatitis B Virus

In brief

The purpose of this study is to evaluate the safety and immunotherapeutic activity of cemiplimab in participants with hepatitis B virus (HBV) on suppressive antiviral therapy.

Key facts

Study ID

NCT04046107

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

0

Starts

2024-01-01

Expected to finish

2027-09-30

Last updated by the study team

2023-09-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic HBV infection (defined as hepatitis B surface antigen [HBsAg] positive).
• Receiving treatment at the time of study entry and for ≥12 months prior to study entry with HBV-active nucleos(t)ides, with tenofovir- or entecavir-containing therapy: tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), TDF/emtricitabine (FTC), TAF/FTC, or entecavir.
• Ability and willingness of participant to provide informed consent.
• Ability and willingness of participant to continue HBV antiviral therapy throughout the study.
• Weight ≥40 kg and <200 kg.
• Evidence of limited or no evidence of fibrosis (F0-F2) by liver biopsy or non-invasive alternative, as defined in the study protocol.
• The following laboratory values obtained within 60 days prior to study entry:
• HBV DNA level <20 IU/mL
• Documentation of hepatitis B e antigen (HBeAg) status (positive or negative)
• Hemoglobin ≥14.0 g/dL for male, ≥12.0 g/dL for female participants
• Platelets ≥150,000/mm\^3
• Absolute neutrophil count (ANC) >1500/mm\^3
• International normalized ratio (INR) ≤1.1
• Albumin ≥3.5 g/dL
• Creatinine Clearance ≥60 mL/min, as calculated by the Cockcroft-Gault equation
• NOTE: A calculator for the Cockcroft-Gault equation is available on the Data Management Center (DMC) website at www.fstrf.org.
• Aspartate aminotransferase (AST) serum glutamic:oxaloacetic transaminase (SGOT) <1.25 x ULN
• ALT serum glutamic:pyruvic transaminase (SGPT) <1.25 x ULN
• Direct bilirubin ≤1.0 x ULN
• AM cortisol >10 mcg/dL and <ULN
• NOTE A: Female participants on estrogen-containing oral contraception or other exogenous estrogen treatment may repeat the AM cortisol as part of screening to determine eligibility. AM cortisol should be drawn prior to 12 noon or per local lab requirements.
• NOTE B: Participants with a low cortisol level that was drawn after 10:00 AM may repeat the AM cortisol as part of screening to determine eligibility.
• Normal creatinine phosphokinase (CPK) level
• Thyroid stimulating hormone (TSH) and free thyroxine (T4) level within normal limits
• Fasting blood glucose <126 mg/dL

You may not qualify if…

• Any malignancy within the 5 years prior to study entry or current malignancy requiring cytotoxic therapy.
• NOTE: A history of non-melanoma skin cancer (e.g., basal cell carcinoma or squamous cell skin cancer) at any time is not exclusionary.
• Current chronic, acute, or recurrent bacterial, fungal, or viral (other than HBV) infections that are serious, in the opinion of the site investigator, and that required systemic therapy within 30 days prior to study entry.
• Prior history of or active autoimmune disorders including but not limited to inflammatory bowel diseases, scleroderma, severe psoriasis, myocarditis, uveitis, pneumonitis, systemic lupus erythematosus, rheumatoid arthritis, optic neuritis, myasthenia gravis, adrenal insufficiency, hypothyroidism and/or hyperthyroidism, autoimmune thyroiditis, hypophysitis, multiple sclerosis, or sarcoidosis.
• NOTE: For questions related to the definition of autoimmune disorders, sites should contact the team per the study protocol.
• Any known acquired or congenital immune deficiency.
• History of chronic obstructive pulmonary disease (COPD).
• History of significant pulmonary conditions.
• Unstable asthma (e.g., sudden acute attacks occurring without an obvious trigger) or asthma requiring:
• Daily steroid or long-acting beta-agonist prevention
• Hospitalization in the 2 years prior to entry
• A history of chronic congestive heart failure or other significant cardiac condition.
• Any active clinically significant medical condition that, in the opinion of the site investigator, would place the participant at increased risk.
• History of non-infectious pneumonitis within the last 5 years prior to study entry.
• Retinopathy or uveitis within 180 days prior to study entry.
• Any acute or chronic psychiatric diagnoses that, in the opinion of the investigator, make the participant ineligible for participation.
• Any vaccination within 30 days prior to entry with the exception of SARS-CoV-2 vaccination..
• NOTE: Individuals who require vaccination must delay screening for the study until 30 days after receiving the last injection.
• Human immunodeficiency virus (HIV) infection.
• Evidence of current (within 1 year prior to entry) Hepatitis delta virus (HDV) infection (HDV antibody positive).
• Acute or serious illness, in the opinion of the site investigator, requiring systemic treatment and/or hospitalization within 30 days prior to study entry.
• Alpha-Fetoprotein (AFP) >100 within 60 days prior to study entry in the absence of imaging within the prior 6 months prior to study entry to exclude hepatocellular carcinoma (HCC).
• Any known bleeding disorder (i.e., hemophilia).
• Receipt of investigational drug or device within 6 months prior to study entry.
• History of treatment with a phosphoinositide 3-kinase inhibitor, including idelalisib.

Where it is running

• Ucsf Hiv/Aids Crs — San Francisco, California, United States
• The Ponce de Leon Center CRS — Atlanta, Georgia, United States
• Massachusetts General Hospital CRS (MGH CRS) — Boston, Massachusetts, United States
• 12201, Hospital Nossa Senhora da Conceicao CRS — Porto Alegre, Brazil
• 12101, Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS — Rio de Janeiro, Brazil
• Toronto General Hospital CRS — Toronto, Ontario, Canada
• Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site # 31802) — Bangkok, Thailand
• Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS (Site ID: 31784) — Chiang Mai, Thailand

Full record on ClinicalTrials.gov

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