About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with recurrent or metastatic squamous-cell carcinoma of the head and neck not amenable to local therapy and/or with metastatic disease and with an indication to treatment by anti-PD1 immunotherapy
Trial design
Case-only
Prospective
Treatments tested in this trial
Immunotherapy
Druganti-PD1
Treatment groups
Trial outcomes
Primary outcomes
prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response.
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.
objective response according to iRECIST criteria (immune response evaluation criteria in solid tumours)
Secondary outcomes
Prospective validation of the expression of interferon-gamma signature to predict progression free survival.
Time from date of inclusion to the event of tumor recurrence or clinical progression or radiological progression on primary tumor or on lymph nodes or on metastasis or death whatever the cause.
Prospective validation of the expression of interferon-gamma signature to predict overall survival.
Time from date of inclusion to death whatever the cause.
Prospective validation of the expression of interferon-gamma signature to predict duration of objective response.
Time from date of first observation of objective response to progressive disease according to RECIST v1.1 or death..
Exploratory outcome : investigation of the expression of other molecular signatures such as immune cells panel within the tumor microenvironment to predict anti-PD1 immunotherapy response.
objective response according to RECIST v1.1
Sponsors and contacts
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Centre Paul Strauss
Lead sponsor
Centre National de la Recherche Scientifique, France
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator