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Study on Xevinapant and Radiotherapy for High-Risk Head and Neck Cancer Patients Unable to Take High-Dose Cisplatin

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called squamous cell carcinoma of the head and neck. This cancer affects areas such as the mouth, throat, and voice box. The study is specifically for patients who have had surgery to remove the cancer but are at high risk of the cancer coming back. These patients are not able to receive a common chemotherapy drug called high-dose cisplatin due to various health reasons. The treatment being tested in this study is a medication called xevinapant, also known by its code name Debio 1143. Xevinapant is given as an oral solution, which means it is taken by mouth in liquid form. The study will compare the effects of xevinapant combined with radiotherapy to a placebo combined with radiotherapy.

The purpose of this study is to see if adding xevinapant to radiotherapy can improve the time patients remain free from cancer after treatment, which is known as disease-free survival. Participants in the study will be randomly assigned to one of two groups. One group will receive xevinapant and radiotherapy, while the other group will receive a placebo and radiotherapy. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure the results are not biased.

The study will take place over a period of time, with participants receiving treatment and being monitored for any changes in their health. The goal is to determine if xevinapant can help prevent the cancer from returning in patients who are at high risk and cannot receive high-dose cisplatin. This research could provide important information about new treatment options for people with this type of cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants are assessed to ensure they meet the eligibility criteria. This includes having a confirmed diagnosis of squamous cell carcinoma of the head and neck, having undergone surgery with curative intent, and being at high risk for relapse.

    Participants must be ineligible for high-dose cisplatin due to specific health criteria, such as impaired kidney function or hearing loss.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of either xevinapant or a placebo. This is an oral solution taken as part of the study protocol.

    Participants also receive radiotherapy as part of their treatment regimen. The combination aims to improve disease-free survival.

  3. Step 3

    Treatment schedule

    The treatment with xevinapant or placebo is administered in cycles. Each cycle's duration and the specific dosage are determined by the study protocol and the participant's health status.

    Radiotherapy is administered concurrently with the oral treatment, following a schedule that is standard for the participant's condition.

  4. Step 4

    Monitoring and assessments

    Throughout the study, participants undergo regular monitoring to assess their response to treatment and any side effects. This includes imaging tests like CT or MRI to check for disease status.

    Participants' overall health, including blood tests and other assessments, is regularly evaluated to ensure safety and effectiveness of the treatment.

  5. Step 5

    Completion of treatment

    Upon completion of the treatment cycles, participants continue to be monitored for disease-free survival, which is the primary endpoint of the study.

    Follow-up assessments are conducted to track long-term outcomes and any potential late effects of the treatment.

Who can join the trial?

10 criteria

  • Participants must have had surgery to remove a type of cancer called squamous cell carcinoma from the head and neck area.
  • Participants should be able to perform daily activities with little or no help, as measured by a scale called the Eastern Cooperative Oncology Group Performance Status (ECOG PS), with a score between 0 and 2.
  • Participants must have had surgery on specific areas such as the mouth, throat, or voice box within 4 to 10 weeks before starting the study treatment.
  • Participants with cancer in the throat area must know their human papillomavirus (HPV) status, which is determined by a specific test.
  • Participants should have no remaining cancer visible on scans like CT or MRI and must be at high risk of cancer returning, based on certain criteria.
  • Participants should not be able to receive a high dose of a chemotherapy drug called cisplatin due to reasons like reduced kidney function, hearing problems, nerve issues, or age-related factors.
  • Participants must have normal blood, kidney, and liver function as defined in the study protocol.
  • Participants must meet other specific criteria outlined in the study protocol.
  • Both men and women can participate in the study.
  • Participants must be adults, as the study is not for children.

Who cannot join the trial?

10 criteria

  • Patients who have not had surgery to remove a type of cancer called squamous cell carcinoma in the head and neck area.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specific clinical trial group required for the study.
  • Patients who are not able to receive the study treatment safely.
  • Patients who have other medical conditions that might interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had another type of cancer within the last five years, except for certain skin cancers or in situ cervical cancer.
  • Patients who have a history of severe allergic reactions to the study medication or similar drugs.
  • Patients who have an active infection that requires treatment.
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Investigated drugs

Xevinapant is a medication being studied for its potential to improve disease-free survival in patients with resected squamous cell carcinoma of the head and neck. It is being tested in combination with radiotherapy to see if it can help prevent the cancer from returning in patients who are at high risk for relapse and cannot receive high-dose cisplatin.

What is already known about the treatment

Xevinapant – Xevinapant is administered orally and is currently being studied in clinical trials for its potential use in treating resected squamous cell carcinoma of the head and neck. It is in a Phase III trial, indicating it is in the later stages of clinical research. The main therapeutic indication for xevinapant is to improve disease-free survival in patients who are at high risk for relapse and cannot receive high-dose cisplatin. At the molecular level, xevinapant works by inhibiting proteins that prevent cancer cell death, thereby promoting the destruction of cancer cells. It is classified pharmacologically as an inhibitor of apoptosis proteins.

Investigated diseases

Squamous Cell Carcinoma of the Head and Neck – This is a type of cancer that begins in the squamous cells, which are flat cells found in the lining of the head and neck region. It often starts in areas such as the mouth, throat, or voice box. The disease can progress by growing into nearby tissues and potentially spreading to other parts of the body. It is typically associated with risk factors like tobacco use and alcohol consumption. Early stages may present as a sore or lump that does not heal, while advanced stages can lead to more significant symptoms affecting breathing, swallowing, or speech.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508528-36-00Protocol codeMS202359_0002Estimated enrolment648 patientsSponsorMerck Healthcare KGaA

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