*ISA101b + cemiplimab in HPV16 positive Oropharyngeal Cancer Patients
Research type
Research Study
Full title
A Phase II Study of cemiplimab, an anti-PD-1 monoclonal antibody, and ISA101b vaccine in patients with recurrent/metastatic HPV16- positive Oropharyngeal Cancer who have experienced disease progression with prior anti-PD-1 therapy
IRAS ID
290947
Contact name
Anthony Kong
Contact email
Sponsor organisation
ISA Therapeutics B.V.
Eudract number
2020-003652-32
Duration of Study in the UK
2 years, 3 months, 9 days
Research summary
This phase 2 study aims to find out whether the combination of ISA101b and cemiplimab is safe for the treatment of human papillomavirus type 16 positive oropharyngeal cancer (HPV16P-OPC) and whether this combination improves the HPV16P-OPC treatment response and survival rate compared to treatment with cemiplimab alone.
ISA101b is a therapeutic vaccine against HPV16 that is designed to stimulate the body’s immune system to attack and kill HPV16-infected cancer cells and cemiplimab belongs to the class of drugs known as PD-1 inhibitors that work by enhancing the anticancer activity of certain immune system cells known as T-cells. The combination of immune system therapies is a new approach in treating HPV16P-OPC and this study seeks to investigate the safety and effectiveness of this approach in patients who have previously experienced cancer progression whilst being treated with a single PD-1 inhibitor.
All participants in this study will receive the ISA101b vaccine on Days 1, 29, and 50, via subcutaneous injection, in addition to receiving intravenous infusions of cemiplimab every 3 weeks during the treatment period.
The study will consist of a 3-week screening period, a treatment period of up to 2 years, a follow-up visit 1 month after the last dose of study drug, telephone calls at 60 and 105 days after the last dose of study drug and continued telephone calls every 12 weeks for up to 1 year after the last dose of study drug.
Various assessments will be performed during the study including, but not limited to, physical examinations, blood samples, questionnaires, electrocardiograms and Computed Tomography or Magnetic Resonance Imaging scans to determine disease status.
The study will be conducted worldwide at about 40 study clinics, including approximately 2 centres in the UK, with 86 patients participating.
This study is sponsored by ISA Therapeutics B.V.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
22/EM/0191
Date of REC Opinion
16 Mar 2021
REC opinion
Further Information Favourable Opinion