Identifying factors that predict response to PD1 immunotherapy in head and neck cancer
Official title: Identification of Predictive Factors for the Response to Anti-Programmed Cell Death Protein 1 (PD1) Immunotherapy in Head and Neck Squamous Cell Carcinoma
Run by Centre Paul Strauss · NCT05328024 · Data updated 2026-11-12
This study is trying to find out what factors can help predict how well PD1 immunotherapy works for patients with advanced head and neck cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Centre Paul Strauss Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy |
| Locations | 1 site (Strasbourg, France) |
| Status | Recruiting |
| Started | August 25, 2023 |
| Main results expected | August 25, 2029 |
| Study ends | August 25, 2029 |
| Registry record updated | June 5, 2026 |
| Trial ID | NCT05328024 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with recurrent or metastatic squamous-cell carcinoma of the head and neck who are not suitable for local therapy and are indicated for anti-PD1 immunotherapy.
✕Probably not a fit
Patients with head and neck squamous cell carcinoma that can be treated locally or those with contraindications for anti-PD1 immunotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project focuses on collecting blood and tumor samples from patients with recurrent or metastatic squamous-cell carcinoma of the head and neck who are undergoing anti-PD1 immunotherapy. Samples will be taken at various time points, including before treatment, after 50 days of treatment, and during subsequent chemotherapy if needed. The goal is to identify new predictive biomarkers for immunotherapy efficacy and to study changes in the tumor microenvironment following treatment. This observational study aims to enhance understanding of patient responses to immunotherapy.
Why it matters
Potential benefit: If successful, this study could lead to improved patient selection for anti-PD1 immunotherapy, enhancing treatment outcomes for individuals with head and neck cancer.
How similar studies have gone: Other studies have shown promise in identifying predictive biomarkers for immunotherapy, making this approach both relevant and potentially impactful.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Institut de cancérologie Strasbourg Europe
Strasbourg, France, France Recruiting
Study contacts
- Study coordinator: Valérie SARTORI
- Email: promotion-rc@icans.eu
- Phone: 03 68 33 95 23
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.