Identifying factors that predict response to PD1 immunotherapy in head and neck cancer
Identification of Predictive Factors for the Response to Anti-Programmed Cell Death Protein 1 (PD1) Immunotherapy in Head and Neck Squamous Cell Carcinoma
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut de cancérologie Strasbourg Europe Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT05328024 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in identifying predictive biomarkers for immunotherapy, making this approach both relevant and potentially impactful.
Eligibility criteria
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 this trial is running
Strasbourg
- Institut de cancérologie Strasbourg Europe — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Valérie SARTORI
- Email: promotion-rc@icans.eu
- Phone: 03 68 33 95 23
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.