Identification of Predictive Factors for the Response to Anti-Programmed Cell Death Protein 1 (PD1) Immunotherapy in Head and Neck Squamous Cell Carcinoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Identification of Predictive Factors for the Response to Anti-Programmed Cell Death Protein 1 (PD1) Immunotherapy in Head and Neck Squamous Cell Carcinoma

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: Immunotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Recurrent and/or metastatic head and neck carcinoma<br>Patients with indication of anti-PD1 immunotherapy according to recommendations | Drug: Immunotherapy<br>* anti-PD1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | at 3 months after initiation of immunotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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.. | 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 | 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 | 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 | 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 | at 3 months after initiation of immunotherapy |