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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Centre Antoine Lacassagne Nice France
Hopital Tenon Paris France
Institut Jules Bordet Anderlecht Belgium
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Hospital Del Mar Barcelona Spain
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Fakultni Nemocnice Bulovka Prague Czechia
Vitaz Sint-Niklaas Belgium
Radiotherapy Center Cluj S.R.L. Floresti Romania
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
SCRI CCCIT Ges.m.b.H. Salzburg Austria
Centre Hospitalier Prive Saint-Gregoire Saint-Gregoire France
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Landeskrankenanstalten-Betriebsgesellschaft Kabeg Klagenfurt am Wörthersee Austria
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Centre Henri Becquerel Rouen France
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer Toulon France
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Oncocenter Oncologie Clinica S.R.L. Timisoara Romania
Hospital Universitario Lucus Augusti Lugo Spain
Justus-Liebig-Universitaet Giessen Giessen Germany
Groupe Hospitalier Bretagne Sud Lorient France
ARNAS G. Brotzu Cagliari Italy
University Hospital Olomouc Olomouc Czechia
Centre Hospitalier Lyon Sud Pierre Benite France
Universita Degli Studi Di Brescia Brescia Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Clinique Victor Hugo Le Mans France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Francois Baclesse Caen France
Focus Lab Plus S.R.L. Bucharest Romania
Cqqrnyhzr Uylhphcyrlzsyi Skwaztnps Woluwe-Saint-Lambert Belgium
Ijjtxfsg Rkobafkz Dk Cpvkjx Do Mbwlhgqqwhp Montpellier France
Olgmvzozyzxakm Lbpg Gksr Linz Austria
Uwzbdmfyshff Mwcxlpp Cesqukp Giapqkvdo Groningen The Netherlands
Iaujaasu Ciwoei Dtcmpumdmjddvmwyq L'hospitalet De Llobregat Spain
Loogq Gxyuamu Hplfypqv Oj Abkmth Athens Greece
Cxxape Aehxlej dn Curxphgvvcps Mougins France
Htyuqug Pwoyt Dwjxckxalntna Valence France
Iewawgwm Rryazhcfy Pcg Lj Sjnvni Dmk Tcijmc Dgki Aofdfse Iqof Stoxsv Meldola Italy
Apyinnbks Ubj Amsterdam The Netherlands
Arqjlyiqed Pyslxuuu Hwyhhvrs Dk Mssomhufe Marseille France
Cryqgh Hyybrvjejzs Rwozzxpt Uwcmgikcptdpm Dt Tmilp Tours France
Algvnk Mzzkdkx Cniqds Soih Thessaloniki Greece
Nrucbyoi Ivrqbkkw Okpkhezvs Isy Mpqzi Sqriatbxesfxulgsxkdmrdnwdxqh Iqbovuhs Bpcnuajn Cracow Poland
Ulrygtjzdx Oq Aukytvi Edegem Belgium
Uchejkatlo Dzxhp Slkgm Dy Rofw Lz Stanyelm Rome Italy
Fysjgsdwu Pdiv Lc Igjmrcxnfpvby Bqasuglhu Ddb Hfmgyvhl Uoraznrkhcutu Le Pbi Madrid Spain
Hhrrmcky Uicfuvmydgnvt Hgyyzchz Tvxhy y Putynt Inimtoir Cizlas dyahywoxaqzshytjp (apyc Badalona Spain
Htvcldvj Vibo dbkxtxhq Barcelona Spain
Cipqub Orczt Lkatnbj Lille France
Homvqdtj Ubydzixosgokg dm A Cjcjpn A Coruna Galicia Spain
Uxillalmjp Gdwuuds Hazcurku Aizggxj Athens Greece
Ijcifprx Ccmxt Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
31.08.2022
Belgium Belgium
Not recruiting
31.08.2022
Czechia Czechia
Not recruiting
31.08.2022
France France
Not recruiting
31.08.2022
Germany Germany
Not recruiting
31.08.2022
Greece Greece
Not recruiting
31.08.2022
Italy Italy
Not recruiting
31.08.2022
Poland Poland
Not recruiting
31.08.2022
Portugal Portugal
Not recruiting
31.08.2022
Romania Romania
Not recruiting
31.08.2022
Spain Spain
Not recruiting
31.08.2022
The Netherlands The Netherlands
Not recruiting
31.08.2022

Trial locations

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.

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 ID:
2023-508528-36-00
Protocol code:
MS202359_0002
Trial Phase:
Therapeutic confirmatory (Phase III)

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