Cemiplimab with/without ISA101b in HPV16Positive OPC
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study of Cemiplimab Versus the Combination of Cemiplimab With ISA101b in the Treatment of Subjects With HPV16-Positive Oropharyngeal Cancer (OPC)
IRAS ID
250125
Contact name
Kevin Harrington
Contact email
Sponsor organisation
ISA Therapeutics B.V.
Eudract number
2018-000789-13
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
17927, IND number
Duration of Study in the UK
4 years, 4 months, 0 days
Research summary
This is a research study of an experimental drug called ISA101b vaccine in combination with another experimental drug called cemiplimab for the treatment of oropharyngeal cancer (OPC), a type of cancer of the head and neck region.
The main purpose of this study is to 1) evaluate the safety and tolerability of the combination of cemiplimab and ISA101b for the treatment of OPC, and 2) to see if the addition of the ISA101b vaccine to cemiplimab improves the cancer response rate and survival rate compared to treatment with cemiplimab alone. The study will also look at the relationship between HPV16 and the immune system and whether an improved HPV16 immune response assists with better control of cancer.
The experimental drug, ISA101b is a vaccine aimed against infection with HPV16.
ISA101b consists of 12 proteins that stimulate the participant's own immune system against the HPV16 virus. The aim is to control the HPV16 infection and eliminate HPV16-induced lesions (areas of abnormal tissue).The study will include a screening period (4 weeks), treatment period (up to 2 years) and a follow up period (over 1 year).
The study will be done at approximately 50 sites globally and will involve about 164 participants.
REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/1540
Date of REC Opinion
23 Nov 2018
REC opinion
Further Information Favourable Opinion