Status:
RECRUITING
Identification of Predictive Factors for the Response to Anti-Programmed Cell Death Protein 1 (PD1) Immunotherapy in Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Institut de cancérologie Strasbourg Europe
Collaborating Sponsors:
Centre National de la Recherche Scientifique, France
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This project aims to organise the sampling of blood and tumor at key points of the standard of care of patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (HNSCC). This ...
Detailed Description
Tumor and blood samples will be collected on patients treated by anti-PD1 immunotherapy at different timepoints. Tumor samples will be collected (i) before initiation of immunotherapy, (ii) at 50 days...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 25 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05328024
Start Date
August 25 2023
End Date
August 25 2029
Last Update
September 22 2023
Active Locations (1)
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1
Institut de cancérologie Strasbourg Europe
Strasbourg, France, 67033