Clinical trial NCT05328024: Identification of Predictive Factors for the Response to Anti-Programmed Cell Death Protein 1 (PD1) Immunotherapy in Head and Neck Squamous Cell Carcinoma
Official title: Identification of Predictive Factors for the Response to Anti-Programmed Cell Death Protein 1 (PD1) Immunotherapy in Head and Neck Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Lead sponsor: Institut de cancérologie Strasbourg Europe
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2022-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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

Brief summary: 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: 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).

Eligibility criteria: 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 outcomes:
measure: prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response.
timeFrame: at 3 months after initiation of immunotherapy
measure: prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response.
timeFrame: at 3 months after initiation of immunotherapy
Secondary outcomes:
measure: Prospective validation of the expression of interferon-gamma signature to predict progression free survival.
timeFrame: at 3 years after inclusion
measure: Prospective validation of the expression of interferon-gamma signature to predict overall survival.
timeFrame: at 3 years after inclusion
measure: Prospective validation of the expression of interferon-gamma signature to predict duration of objective response.
timeFrame: at 3 years after inclusion
measure: 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.
timeFrame: at 3 months after initiation of immunotherapy
measure: Exploratory outcome : investigation of the expression of other molecular signatures such as immune checkpoints protein expression level to predict anti-PD1 immunotherapy response.
timeFrame: at 3 months after initiation of immunotherapy
measure: 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.
timeFrame: at 3 months after initiation of immunotherapy
measure: Exploratory outcome : investigation of the expression of other molecular signatures such as protein expression level involved in hypoxia to predict anti-PD1 immunotherapy response.
timeFrame: at 3 months after initiation of immunotherapy
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe
Study officials:
References: