Finding tissue and blood markers that predict response to immunotherapy in recurrent or metastatic upper throat and mouth squamous cell cancer
Identification of Individual Histological and Blood Markers in Patients With Recurrent or Metastatic Upper Aerodigestive Tract Squamous Cell Carcinoma in Response to Immunotherapies
NA · Fondation Hôpital Saint-Joseph · NCT06061705
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Hôpital Saint-Joseph (other) |
| Drugs / interventions | immunotherapy, nivolumab, pembrolizumab, chemotherapy |
| Locations | 3 sites (Paris and 2 other locations) |
| Trial ID | NCT06061705 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Paris and 2 other locations
- Hôpital Saint-Joseph — Paris, France (RECRUITING)
- Hôpital Bichat — Paris, France (RECRUITING)
- Hôpital Saint-Louis — Paris, France (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Eric Raymond, MD, PhD
- Email: eraymond@ghpsj.fr
- Phone: 144127883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Squamous Cell Carcinoma of the Oropharynx