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Be Part of Research - Trial Details - Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)
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Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)

Stopped

Open to: ALL

Age: 18.0 - N/A

Sutton Wirral Northwood Manchester Torquay Somerset Leeds London

Medical Conditions

Head and Neck Neoplasms

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Oct 2022 Aug 2024

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Participants will receive 3 cycles of oral solution of Xevinapant (Debio 1143) at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with radiotherapy followed by 3 cycles of monotherapy of Xevinapant (Debio 1143) at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).

Intervention Arm Group : Arm A: Xevinapant (Debio 1143) + IMRT;

Intervention Type : RADIATION
Intervention Description : Participants will receive 66 Gy of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week.

Intervention Arm Group : Arm A: Xevinapant (Debio 1143) + IMRT;Arm B: Placebo + IMRT;

Intervention Type : DRUG
Intervention Description : Participants will receive 3 cycles of oral solution of placebo matched to Xevinapant (Debio 1143) once daily from Day 1 to 14 per 3-week cycle in combination with radiotherapy followed by 3 cycles of monotherapy of placebo matched to Xevinapant (Debio 1143) from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).

Intervention Arm Group : Arm B: Placebo + IMRT;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal Marsden NHS Foundation Trust
    Sutton
  • Clatterbridge Cancer Centre
    Wirral
  • Mount Vernon Cancer Centre
    Northwood
  • The Christie Hospital - Dept of Oncology
    Manchester
  • Torbay Hospital - PARENT
    Torquay
  • Musgrove Park Hospital - PARENT
    Somerset
  • St James's University Hospital - Dept of Oncology
    Leeds
  • Royal Marsden Hospital-London - Dept of Haematology/Oncology Research
    London


The study is sponsored by EMD Serono Research & Development Institute, Inc. and is in collaboration with Merck KGaA, Darmstadt, Germany.



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Read full details for Trial ID: NCT05386550
Last updated 20 September 2024

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