Phase 3 study of Debio 1143 (TrilynX) in head and neck carcinoma
Research type
Research Study
Full title
A randomised, double-blind placebo-controlled, Phase 3 study of Debio 1143 in combination with platinum-based chemotherapy and standard fractionation intensity-modulated radiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy (TrilynX).
IRAS ID
285539
Contact name
Kevin Harrington
Contact email
Sponsor organisation
Debiopharm International S.A.
Eudract number
2020-000377-25
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
6 years, 9 months, 0 days
Research summary
Debiopharm is conducting a study of an investigational medicine (also known as “study medicine”) called Debio 1143 that increases the ability of other medicines to kill cancer cells, which can reduce tumour growth. This investigational medicine is being assessed to see if it can improve treatment outcomes for patients with locally advanced squamous cell carcinoma (thin, flat cells) of the head and neck when used in combination with platinum-based chemotherapy and radiotherapy.
The main purpose of this study is to learn how well the study medicine works and how safe the study medicine is compared with a placebo. There will be approximately 700 male and female adult participants in this study, across 200 study centres worldwide.
Participants will be in the study for up to 7 years. Participation will consist of approximately 56 visits at the study centre over a period of 5 years, followed by telephone calls every 6 months over a period of maximum 2 years depending on when the participant entered the study.
Before any study-related tests and procedures can be done, participants will be asked to read and sign a Participant Information Sheet and Informed Consent Form. After the Informed Consent Form(s) is signed, the study will begin with a screening visit.
The study is divided into 3 time periods:
•a screening period
•a treatment period (5 months)
•a follow up period (5 years since study start), followed by telephone calls over a period of maximum 2 years
If the study doctor determines that a participant meets all the requirements to be in the study, they will be randomly assigned to one of two treatment groups. Participants will be assigned to receive one of the following treatments:
•Standard treatment of chemotherapy and radiotherapy plus the study medicine Debio 1143
•Standard treatment of chemotherapy and radiotherapy plus PlaceboREC name
London - Fulham Research Ethics Committee
REC reference
20/LO/1285
Date of REC Opinion
9 Feb 2021
REC opinion
Further Information Favourable Opinion