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Can a simple test predict immunotherapy success in head and neck cancer?

NCT ID NCT05328024

Knowledge-focused Sponsor: Centre Paul Strauss Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 study is collecting blood and tumor samples from 60 people with recurrent or metastatic head and neck cancer who are receiving standard anti-PD1 immunotherapy. The goal is to find biological markers that can predict whether the immunotherapy will work. Researchers will analyze the samples to see if certain genetic signatures are linked to better outcomes.

What this could mean

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

Active substance
anti-PD1 immunotherapy
What this could lead to
If successful, this could help doctors predict which patients will benefit from anti-PD1 immunotherapy, leading to more personalized treatment.
What could go wrong
This is an observational study, not a treatment trial. It may not identify reliable biomarkers, and results may not change current practice.

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.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Patients with recurrent or metastatic squamous-cell carcinoma of the head and neck not amenable to local therapy and/or with metastatic disease and with an indication to treatment by anti-PD1 immunotherapy

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: * Patients with recurrent squamous-cell carcinoma of the head and neck not amenable to local therapy and/or with metastatic disease * Tumor directly accessible to clinical examination (tumor of oral cavity and of oropharynx) and/or cervical lymphadenopathy accessible to echography allowing to realise biopsy under local anesthesia * Indication to treatment by anti-PD1 immunotherapy according to French competent authority recommendations * Performance status 0, 1 or 2 * At least one measurable lesion on RECIST V1.1 criteria Exclusion Criteria: * Head and neck squamous cell carcinoma accessible to a local treatment * Cancer of nasopharynx, sinus or nasal cavity * Other histology than epidermoid * Patients with contraindication for anti-PD1 immunotherapy

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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

As listed by the trial registrant

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

Head and neck cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Institut de cancérologie Strasbourg Europe

    RECRUITING

    Strasbourg, France, 67033, France

More trials for these conditions

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