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PD-1 Inhibitor
Safety and Immunotherapeutic Activity of Cemiplimab in Participants With HBV on Suppressive Antiviral Therapy
Phase 1 & 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up entry and weeks 6, 8, 12, 14, 18, 24, 36, 54, 72,90
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing cemiplimab, a medicine that boosts the immune system, in patients with hepatitis B who are already on antiviral therapy. The goal is to see if it can help their bodies fight the virus more effectively. Cemiplimab is being studied for its potential to enhance immune response in patients with various conditions, including cutaneous squamous cell carcinoma.
Eligible Conditions
- Hepatitis B
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ entry and weeks 6, 8, 12, 14, 18, 24, 36, 54, 72,90
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~entry and weeks 6, 8, 12, 14, 18, 24, 36, 54, 72,90
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Therapeutic procedure
Number of participants who experienced any targeted safety event that is related to study treatment
Number of participants with any AE
Secondary study objectives
Change in quantitative HBeAg from pre-treatment
Change in quantitative HBsAg from pre-treatment
Detection of hepatitis B core-related antigen (HBcrAg)
+3 moreSide effects data
From 2023 Phase 3 trial • 608 Patients • NCT0325726725%
Pyrexia
13%
Diarrhoea
13%
Subcutaneous abscess
13%
Hyperthyroidism
13%
Nausea
13%
Constipation
13%
Infusion related reaction
13%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemotherapy to Cemiplimab*
Cemiplimab
Chemotherapy*
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3: Cemiplimab (3 mg/kg)Experimental Treatment1 Intervention
Participants will receive cemiplimab 3 mg/kg dosed in two infusions, one infusion at Week 6 and Week 12.
Group II: Cohort 2: Cemiplimab (1 mg/kg)Experimental Treatment1 Intervention
Participants will receive cemiplimab 1 mg/kg dosed in two infusions, one infusion at Week 6 and Week 12.
Group III: Cohort 1: Cemiplimab (0.3 mg/kg)Experimental Treatment1 Intervention
Participants will receive cemiplimab 0.3 mg/kg dosed in two infusions, one infusion at Week 6 and Week 12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1470
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,327 Previous Clinical Trials
5,365,989 Total Patients Enrolled
17 Trials studying Hepatitis B
9,831 Patients Enrolled for Hepatitis B
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
385,843 Total Patients Enrolled
Debika Bhattacharya, MDStudy ChairUCLA CARE Center CRS
Jordan Feld, MD, PhDStudy ChairUniversity Health Network / Toronto Centre for Liver Disease
Raymond T. Chung, MDStudy ChairMassachusetts General Hospital CRS
1 Previous Clinical Trials