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

Institut de cancérologie Strasbourg Europe

Status: Enrolling

Conditions: Head and Neck Cancer

Treatments: Drug: Immunotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT05328024

2021-003

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Recurrent and/or metastatic head and neck carcinoma

Description:

Patients with indication of anti-PD1 immunotherapy according to recommendations

Treatment:

Drug: Immunotherapy