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Head and neck cancer drug combo safety trial halted early

NCT ID NCT06056310

Symptom relief Sponsor: EMD Serono Research & Development Institute, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study aimed to see if adding the drug xevinapant to standard chemoradiotherapy is safe for people with advanced head and neck cancer that cannot be removed by surgery. The study planned to enroll 18 participants but was terminated early. The main focus was on side effects and tolerability.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

18 people

The number who actually took part.

Started

Jan 2024

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 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.

Inclusion Criteria: * Participants having an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 - 1 * Histologically confirmed diagnosis in previously untreated Locally Advanced Squamous Cell Carcinoma of Head and neck (LA SCCHN) patient (Stage III, IVA, or IVB according to the American Joint Committee on Cancer \[AJCC\]/ Tumor Nodes and metastases (TNM) Staging System, 8th Edition) suitable for definitive Chemoradiotherapy (CRT), with one of the following primary sites: oropharynx (OPC) Human Papillomavirus (HPV)-negative, hypopharynx, and larynx * Participant should be able to swallow liquids or has an adequately functioning feeding tube, gastrostomy, or jejunostomy in place. For participants requiring liquid nutrition at baseline or during the study including the follow-up period, access to liquid nutrition supply should be ensured * Participant with evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by CT scan and/or MRI, based on RECIST v 1.1. * Adequate hematological, hepatic, and renal function as defined in the protocol * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Primary tumor of nasopharyngeal, paranasal sinuses, nasal, or oral cavity, salivary, thyroid, or parathyroid gland pathologies, skin, or unknown primary site * Metastatic disease (Stage IVC as per AJCC/TNM, 8th Edition) * Existing need of a hearing aid or greater than or equal to (\>=) 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated * Known history of infection with human immunodeficiency virus (HIV). If unknown history of HIV, an HIV screening test is to be performed and participants with positive serology for HIV-1/2 must be excluded * Known gastrointestinal disorder with clinically established malabsorption syndrome and major gastrointestinal surgery in the last 12 months that may limit oral absorption * Other protocol defined exclusion criteria could apply

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma laryngeal disorder

As listed by the trial registrant

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

Head and neck cancer

Contacts and locations

Locations

  • Avera McKennan Hospital and University Health Center

    Sioux Falls, South Dakota, 57105, United States

  • Centre Hospitalier de l'Ardenne - PARENT

    Libramont, Belgium

  • China Medical University Hospital

    Taichung, Taiwan

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinica Universidad de Navarra (MAD) - Oncology Service

    Madrid, Spain

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, Israel

  • Hospital Universitario Fundacion Jimenez Diaz - Oncology

    Madrid, Spain

  • Hospital Universitario Virgen del Rocio - Oncology Service

    Seville, Spain

  • ICO Girona - Hospital Universitari de Girona Dr Josep Trueta - Servicio de Oncologia Medica

    Girona, Spain

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, Taiwan

  • Karmanos Cancer Institute - PARENT

    Detroit, Michigan, 48201, United States

  • Konkuk University Medical Center

    Seoul, South Korea

  • Montefiore Medical Center PRIME

    The Bronx, New York, 10467, United States

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140, United States

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Pusan National University Hospital

    Busan, South Korea

  • Pusan National University Yangsan Hospital

    Yangsan, South Korea

  • Seoul National University Bundang Hospital

    Seongnam, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, South Korea

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • Universitair Ziekenhuis Gent - Medical Oncology

    Ghent, Belgium

  • Uza - Parent

    Edegem, Belgium

  • Vitaz

    Sint-Niklaas, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.