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Can a new drug boost radiation's power against head and neck cancer in older patients?

NCT ID NCT05724602

Disease control Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This phase II trial is investigating whether adding the experimental drug xevinapant to standard radiation therapy can improve outcomes for adults aged 70 and older with locally advanced head and neck cancer. Participants are randomly assigned to receive either xevinapant or a placebo alongside radiation, followed by additional cycles of the assigned treatment alone. The study aims to see if xevinapant helps keep the cancer from growing or returning in this older population.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
xevinapant (an experimental drug) combined with intensity-modulated radiotherapy
What this could lead to
If successful, this could lead to a new treatment option that improves cancer control and survival for older patients with head and neck cancer who cannot tolerate standard chemotherapy.
What could go wrong
This is an early-phase study with a small number of participants, so results may not be conclusive. Xevinapant may cause side effects, and its benefit over radiotherapy alone is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

13 people

The number who actually took part.

Started

Nov 2023

Finished

Feb 2025

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

70 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Main Inclusion Criteria: * Age ≥ 70 years. * Pathologically proven new diagnosis of HNSCC of oral cavity, oropharynx, hypopharynx and larynx tumor. * cT3-4 cN0 cM0 or cT1-4 cN1-3 cM0 except for T1-2N1 p16 positive oropharyngeal cancer (AJCC 8th edition). * HPV status using p16 immunohistochemistry (IHC) available for oropharyngeal squamous cell carcinoma. * Measurable disease per RECIST 1.1. * Eastern Coperative Oncology Group Performance Status (ECOG PS) ≤ 1. * Intention to treat with curative intent primary radiotherapy alone. * Able to swallow liquids or has an adequately functioning feeding tube, gastrostomy or jejunostomy placed. * Adequate hematologic, renal, and hepatic function as indicated by: * Creatinine clearance ≥ 30 mL/min, measured with the Cockroft and Gault formula. * Absolute neutrophil count ≥ 1 500 cells/μL. * Platelets ≥ 100 000 cells/μL. * Hemoglobin ≥ 9.0 g/dL or ≥5.6 mmol/L (blood transfusions during screening are permitted). * AST and ALT ≤ 3.0 × upper limit of normal (ULN). * Total bilirubin ≤ 1.5 × ULN (up to 2.0 × ULN is allowed if the direct bilirubin level is normal and the elevation is limited to indirect bilirubin). * Written informed consent must be signed according to ICH/GCP, and national/local regulations. Main Exclusion Criteria: * Unknown primary, primary nasopharynx and paranasal sinus. * Two primaries. * Any previous or current treatment for invasive head and neck cancer, including induction chemotherapy, surgery, concomitant chemotherapy and cetuximab. * Gastrointestinal disorders that could affect drug absorption. * Another malignancy in the previous 3 years with exception of curatively treated disease with no evidence of recurrence. * Known allergy to xevinapant or any excipient known to be present in active or placebo formulation. * Active gastrointestinal bleeding, or any other uncontrolled bleeding requiring more than 2 red blood cell transfusions or 4 units of packed red blood cells within 4 weeks prior to enrolment * Non-Decompensated or symptomatic liver cirrhosis (Child-Pugh score: B or C). * Impaired cardiovascular function or clinically significant cardiovascular diseases * Any uncontrolled, intercurrent illness or clinical situation that would in the judgment of investigator, limit compliance with study requirements. This includes but is not limited to uncontrolled active infections, defined as any infection requiring IV antibiotics within 7 days prior to enrolment.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally advanced head and neck squamous cell carcinoma

Contacts and locations

Locations

  • Academisch Ziekenhuis Maastricht

    Maastricht, Netherlands

  • Amsterdam UMC - locatie VUMC

    Amsterdam, Netherlands

  • Assistance Publique Hopitaux Paris- APHP - APHP Sorbonne Univ - Hopital Tenon

    Paris, France

  • Assistance Publique Hopitaux Paris- APHP - APHP Sorbonne Univ - Hopital la Pitie-Salpetriere

    Paris, France

  • Centre Oscar Lambret

    Lille, France

  • Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum

    Berlin, Germany

  • Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert, Belgium

  • Helse Bergen HF -Haukeland Hospital - Univ. Hosp

    Bergen, Norway

  • IRCCS--Ospedale Bellaria-Bologna

    Bologna, Italy

  • Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals

    Barcelona, Spain

  • Institut de Cancerologie de Lorraine

    Nancy, France

  • Istituto Clinico Humanitas

    Rozzano, Italy

  • NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

    Glasgow, United Kingdom

  • Onze Lieve Vrouw Ziekenhuis

    Aalst, Belgium

  • Oslo University Hospital - Radiumhospitalet

    Oslo, Norway

  • St Luke Hospital & SLRON - SLRON - St. Luke'S Hospital Rathgar

    Rathgar, Ireland

  • The Clatterbridge cancer Center NHS foundation Trust - Clatterbridge Cancer Center - Wirral

    Birkenhead, United Kingdom

  • The Institute Of Oncology

    Ljubljana, Slovenia

  • Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi

    Florence, Italy

  • Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center

    Hamburg, Germany

  • Universitaetsklinikum - Essen

    Essen, Germany

  • Universitair Medisch Centrum Groningen - University Medical Center Groningen

    Groningen, Netherlands

  • Universitair Ziekenhuis Gent

    Ghent, Belgium

  • University Hospital Galway

    Galway, Ireland

  • University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

    Bristol, United Kingdom

  • Vall D Hebron - Hospital Universitari Vall d'Hebron

    Barcelona, Spain

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