Identification of Predictive Factors for the Response to Anti-Programmed Cell Death Protein 1 (PD1) Immunotherapy in Head and Neck Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immunotherapy.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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).
Interventions
- Drug Immunotherapy
anti-PD1
Primary outcome measures
- prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response. [Time frame: at 3 months after initiation of immunotherapy]
- prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response. [Time frame: at 3 months after initiation of immunotherapy]
Secondary outcome measures (7)
- Prospective validation of the expression of interferon-gamma signature to predict progression free survival. [Time frame: at 3 years after inclusion]
- Prospective validation of the expression of interferon-gamma signature to predict overall survival. [Time frame: at 3 years after inclusion]
- Prospective validation of the expression of interferon-gamma signature to predict duration of objective response. [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. [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. [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. [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. [Time frame: 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- Institut de cancérologie Strasbourg Europe — Strasbourg
Publications
- Helene C, Conrad O, Pflumio C, Borel C, Voegelin M, Bernard A, Schultz P, Onea MA, Jung A, Martin S, Burgy M. Dynamic profiling of immune microenvironment during anti-PD-1 immunotherapy for head and neck squamous cell carcinoma: the IPRICE study. BMC Cancer. 2023 Dec 8;23(1):1209. doi: 10.1186/s12885-023-11672-x. PMID 38066522
Identifiers
NCT: NCT05328024 · 2021-003