XRAY VISION
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, 2-arm Phase III study to assess efficacy and safety of xevinapant and radiotherapy compared to placebo and radiotherapy for demonstrating improvement of disease-free survival in participants with resected squamous cell carcinoma of the head and neck, who are at high risk for relapse and are ineligible for high-dose cisplatin
IRAS ID
1006548
Contact name
Hansjoerg Rittler
Contact email
Sponsor organisation
Merck Healthcare KGaA
Eudract number
2022-001144-18
Research summary
Xevinapant is an investigational drug that is being developed for the treatment of patients with different types of cancer. The study drug is designed to bind to a group of proteins, called ‘inhibitor of apoptosis’ (IAP) proteins. As the name suggests, these proteins inhibit or prevent apoptosis (the natural death of cells). This can lead to uncontrolled cell growth and cancer. By binding to and stopping the activity of the IAP proteins, the study drug may help in the treatment of cancer.
This is a double-blind placebo-controlled study. A ‘placebo’ looks like the study drug but does not have any active substance in it. Participant and study doctor will not know to which treatment group participant have been assigned (although, if study doctor needs to find out, he/she can do so).
This is a randomised study. Participant will be randomly (like flipping a coin) assigned to receive either the study drug or placebo, along with the radiotherapy. Patients have an equal chance of receiving study drug or placebo.
The study medication will be provided as a liquid to be taken by mouth (orally ) early each morning. Participant will also receive the radiotherapy once daily for 5 days every week for first 6.5 weeks, which can be extended until 9 weeks.
This study has 3 parts:
· Screening period (up to 4 weeks before the first dose of the study medication)
Participant will need to visit the study centre to check if the study is right for him\her.
· Treatment period (up to 17 weeks)
During the treatment period, participant will receive the assigned study medication once daily for 14 days for the first 3 cycles (each cycle will last for 3 weeks), along with radiotherapy as per study schedule. After completing the first 3 cycles, participant will receive only the assigned study medication, once daily for 14 days for the next 3 cycles.
Follow-up period (approx.. 5 years)
Sponsor of this study is Merck KGaA,REC name
London - Surrey Borders Research Ethics Committee
REC reference
23/LO/0135
Date of REC Opinion
23 Aug 2023
REC opinion
Further Information Favourable Opinion