Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Biopsies may reveal why some cancers respond to immunotherapy

NCT ID NCT03412058

Knowledge-focused Sponsor: UNICANCER 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study is looking at whether tumor biopsies can help predict which patients with melanoma, non-small cell lung cancer, or head and neck cancer will respond to immunotherapy drugs called PD-1 or PD-L1 inhibitors. Researchers will collect tissue samples from about 152 adults before, during, and after treatment to look for patterns that match with tumor shrinkage. The goal is to develop a 'response signature' that could guide treatment decisions in the future.

What this could mean

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

Active substance
Tumor biopsies (tissue samples) taken before, during, and after treatment with PD-1 or PD-L1 inhibitors (immunotherapy drugs)
What this could lead to
If successful, this could help doctors identify which patients are most likely to benefit from immunotherapy, avoiding unnecessary treatments and side effects.
What could go wrong
The study is observational and does not test a new treatment. The predictive signature may not prove accurate, and results may not apply to all patients or cancer types.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

152 people

The number who actually took part.

Started

Jun 2018

Finished

Dec 2025

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.

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: 1. Age ≥18 years old. 2. Histological confirmed diagnosis of one of the following: * Non-resectable (stage III) or metastatic (stage IV) melanoma, * Metastatic, EGFR- and ALK-negative, non-small cell lung cancer with a high level of PD-L1 expression (defined as a "tumour proportion score" of greater than or equal to 50%) which has not been previously treated with chemotherapy in the metastatic setting, * Head and Neck squamous cell carcinoma that is that is recurrent or progressing following reference chemotherapy and that is not amenable to surgery or radiation therapy. 3. Indicated for treatment with a PD-1 or PD-L1 antagonist according to the European Marketing Authorisation or the conditions of a Temporary Authorisation of Use. 4. Estimated life expectancy ≥16 weeks. 5. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2. 6. Presence of at least one tumour lesion (except bone lesions) accessible to biopsy, if a biopsy is required (see below). 7. Willing and able to provide a pre-treatment biopsy sample, if a biopsy is required. Note: where an archived tumour sample is available, this archived sample can be used in place of a fresh biopsy sample, if the patient has not received any antineoplastic therapy since the collection date. 8. Measurable disease according to RECIST v1.1 (Eisenhauer, 2009). 9. Beneficiary of social insurance coverage. 10. Comprehension of French. 11. Provision of written informed consent (signed and dated) prior to the initiation of any protocol specific procedure. Exclusion Criteria: 1. Any contraindication to treatment with a PD-1 or PD-L1 antagonist. 2. Any contraindication to a biopsy including: platelets \<80 x 10⁹/L, International Normalised Ratio (INR) \>1.5 or prothrombin time (PT) \>1.5 x upper limit of normal range (ULN), prolonged partial thromboplastin time (PTT) in the absence of factor XII deficiency or antiphospholipid antibodies, ongoing treatment with anticoagulants. 3. Bone metastasis as the only disease site available for biopsy. 4. Previous treatment with a PD-1 or PD-L1 antagonist. 5. Individuals deprived of liberty or placed under the authority of a tutor. 6. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Head and neck squamous cell carcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma melanoma non-small cell lung carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

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

Head and neck squamous cell carcinoma Melanoma Non-small cell lung cancer

Contacts and locations

Locations

  • CHU Saint-Etienne, Hôpital Nord

    Saint-Etienne, France

  • CHU de Tours

    Tours, France

  • Centre Antoine Lacassagne

    Nice, France

  • Centre Eugène Marquis

    Rennes, France

  • Centre Georges François Leclerc

    Dijon, France

  • Centre Hospitalier Inter. de Creteil

    Créteil, France

  • Centre Hospitalier de Caen

    Caen, France

  • Centre Jean Perrin

    Clermont-Ferrand, 63011, France

  • Centre Léon Bérard

    Lyon, France

  • Centre Oscar lambret

    Lille, France

  • Gustave Roussy

    Villejuif, France

  • Institut Bergonie

    Bordeaux, France

  • Institut Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, France

  • Institut Claudius Regaud - IUCT- 0

    Toulouse, France

  • Institut Curie

    Paris, France

  • Institut Curie - Hôpital René Huguenin

    Saint-Cloud, France

  • Institut Jean Godinot

    Reims, France

  • Institut Régional du Cancer de Montpellier

    Montpellier, France

  • Institut de cancérologie de l'ouest

    Nantes, France

More trials for these conditions

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