Clinical trial

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

Name

2021-003

Description

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.

Trial arms

Trial start

2023-08-25

Estimated PCD

2029-08-25

Trial end

2029-08-25

Status

Recruiting

Treatment

Immunotherapy

anti-PD1

Arms:

Recurrent and/or metastatic head and neck carcinoma

Size

Primary endpoint

prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response.

at 3 months after initiation of immunotherapy

prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response.

at 3 months after initiation of immunotherapy

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tumor and blood samples.'}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2023-09-22

1 organization

1 product

1 indication

Organization

Institut de Cancérologie Strasbourg Europe

Product

Immunotherapy

Indication

Head and Neck Cancer