This is a double-blind placebo-controlled study. This study is also randomized. In this study, you will randomly (like flipping a coin) receive either the test substance or placebo together with radiotherapy.
Aim of the study
In our research project, we want to find out whether xevinapant works in people with carcinoma of the head and neck when administered together with radiotherapy, whether the test substance is safe to use and how your body copes with taking the test substance.
Who can take part?
Patients who:
- were diagnosed with a carcinoma of the head and neck, which was surgically removed.
- have a high risk of the cancer returning.
- cannot be treated with high-dose chemotherapy.
Procedure
If you take part, you will be randomly assigned to one of 2 groups. They receive either the test substance or the placebo and radiotherapy. This study consists of 3 parts: Pre-test section, treatment section and post-test section. During the treatment period, you will receive the assigned study drug once daily for 14 days for the first 3 cycles (each cycle lasts 3 weeks) along with radiotherapy once daily for 5 days each week. Your participation in this research study will last a maximum of 5 years.
Compensation
Original study name
A randomized, double-blind, placebo-controlled, two-arm Phase III study to evaluate the efficacy and safety of xevinapant and radiotherapy compared to placebo and radiotherapy
BASEC number
2022-01823
Financial support from
Merck Healthcare KGaA