Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Finding tissue and blood markers that predict response to immunotherapy in recurrent or metastatic upper throat and mouth squamous cell cancer

Official title: Identification of Individual Histological and Blood Markers in Patients With Recurrent or Metastatic Upper Aerodigestive Tract Squamous Cell Carcinoma in Response to Immunotherapies

Run by Fondation Hôpital Saint-Joseph · NCT06061705 · Data updated 2026-11-12

This project will try to find tumor and blood markers that predict whether adults with recurrent or metastatic squamous cell cancer of the oropharynx or nearby upper aerodigestive sites will respond to PD‑1 immunotherapy.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorFondation Hôpital Saint-Joseph
Academic / other
Drugs / interventionsimmunotherapy, nivolumab, pembrolizumab, chemotherapy
Locations3 sites (Paris and 2 other locations)
StatusRecruiting
StartedJanuary 29, 2024
Main results expectedDecember 29, 2025
Study endsJune 30, 2026
Registry record updatedJune 24, 2025
Trial IDNCT06061705 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with histologically confirmed recurrent or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx who are candidates for PD‑1 immunotherapy and can undergo a tumor biopsy are ideal candidates.

Probably not a fit

Patients with contraindications to immunotherapy (for example organ transplant recipients), pregnant or breastfeeding people, those under legal guardianship, or those unable to provide consent or undergo biopsy are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional program collects tumor biopsies and blood samples from adults with recurrent or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx who are candidates for PD‑1 immunotherapy. Samples will be analyzed for histological and circulating markers to look for patterns associated with clinical response or progression. The work aims to link individual tumor heterogeneity to treatment outcomes to improve patient selection for immunotherapy. The project is carried out at multiple hospitals in Paris and requires informed consent and the ability to undergo biopsy.

Why it matters

Potential benefit: If successful, the findings could help doctors choose immunotherapy for patients more likely to benefit and avoid ineffective treatments for others.

How similar studies have gone: PD‑1 inhibitors are approved and help a minority of head and neck cancer patients, but prior biomarker studies have shown mixed results and reliable predictive markers remain limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients aged ≥ 18 years
* Patients with histologically confirmed CEVADS involving the oral cavity, oropharynx, hypopharynx or larynx
* Pre-treated patients with a first recurrence (locoregional or metastatic) who are candidates for immunotherapy
* Patient affiliated to a health insurance plan
* French-speaking patient
* Patient with free, informed and written consent

Exclusion Criteria:

* Patients with a contraindication to immunotherapy (transplant patients)
* Pregnant or breast-feeding patients
* Patient under guardianship or curatorship
* Patient under court protection
* Patient deprived of liberty

Where it's running

  • Hôpital Saint-Joseph
    Paris, France
    Recruiting
  • Hôpital Bichat
    Paris, France
    Recruiting
  • Hôpital Saint-Louis
    Paris, France
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.