Identification of Predictive Factors for the Response to Anti-Programmed Cell Death Protein 1 (PD1) Immunotherapy in Head and Neck Squamous Cell Carcinoma
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 will allow to identify new potential predictive biomarkers of efficacy of immunotherapy and to investigate the evolution of the tumoral microenvironment after successive systemic treatments.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response. — at 3 months after initiation of immunotherapy objective response according to RECIST v1.1 (response evaluation criteria in solid tumours)
prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response. — at 3 months after initiation of immunotherapy objective response according to iRECIST criteria (immune response evaluation criteria in solid tumours)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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