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

  • STATUS
    Recruiting
  • End date
    Dec 13, 2027
  • participants needed
    60
  • sponsor
    Institut de cancérologie Strasbourg Europe
Updated on 6 May 2022
measurable disease
carcinoma
squamous cell carcinoma

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.

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).

Details
Condition Head and Neck Cancer
Treatment Immunotherapy
Clinical Study IdentifierNCT05328024
SponsorInstitut de cancérologie Strasbourg Europe
Last Modified on6 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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