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

Institut de cancérologie Strasbourg Europe60 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Head and Neck Cancer

Interventions

Immunotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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)

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

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.

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts