An observational study in Head and Neck Cancer, sponsored by Centre Paul Strauss. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Centre Paul Strauss · Observational
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.
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 after initiation of immunotherapy and, optionally, in case of disease progression, (iii) before the initiation of the new line of chemotherapy and (iv) at 50 days after initiation of chemotherapy. Blood samples will be collected : (i) before initiation of immunotherapy, (ii) at each cycles of treatment until 84 days after initiation of immunotherapy and, optionally, in case of disease progression, (iii) before the initiation of the new line of chemotherapy and (iv) at each cycle until 50 days after initiation of chemotherapy (maximum 2 samples per month).
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Centre Paul Strauss is the lead sponsor of 30 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Patients with indication of anti-PD1 immunotherapy according to recommendations
Drug: Immunotherapy
anti-PD1
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)
Time frame: at 3 months after initiation of immunotherapy
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)
Time frame: at 3 months after initiation of immunotherapy
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.
Time frame: at 3 years after inclusion
Prospective validation of the expression of interferon-gamma signature to predict overall survival.
Time from date of inclusion to death whatever the cause.
Time frame: at 3 years after inclusion
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..
Time frame: at 3 years after inclusion
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
Time frame: at 3 months after initiation of immunotherapy
Exploratory outcome : investigation of the expression of other molecular signatures such as immune checkpoints protein expression level to predict anti-PD1 immunotherapy response.
objective response according to RECIST v1.1
Time frame: at 3 months after initiation of immunotherapy
Exploratory outcome : investigation of the expression of other molecular signatures such as biomarkers expression level involved in immunogenic cell death and in mitophagy to predict anti-PD1 immunotherapy response.
objective response according to RECIST v1.1
Time frame: at 3 months after initiation of immunotherapy
Exploratory outcome : investigation of the expression of other molecular signatures such as protein expression level involved in hypoxia to predict anti-PD1 immunotherapy response.
objective response according to RECIST v1.1
Time frame: at 3 months after initiation of immunotherapy
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