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

Head and Neck Cancer Clinical Trial

— IPRICE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05328024
• Other study ID #: 2021-003
• Status: Recruiting
• Start date: August 25, 2023
• Est. completion date: August 25, 2029

Study information

• Verified date: September 2023
• Source: Institut de cancérologie Strasbourg Europe
• Contact: Valérie SARTORI
• Phone: 03 68 33 95 23
• Email: promotion-rc[@]icans.eu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 25, 2029
• Est. primary completion date: August 25, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• Immunotherapy
anti-PD1

Locations

Country	Name	City	State
France	Institut de cancérologie Strasbourg Europe	Strasbourg

Sponsors (3)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe	Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response.	objective response according to RECIST v1.1 (response evaluation criteria in solid tumours)	at 3 months after initiation of immunotherapy
Primary	prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response.	objective response according to iRECIST criteria (immune response evaluation criteria in solid tumours)	at 3 months after initiation of immunotherapy
Secondary	Prospective validation of the expression of interferon-gamma signature to predict progression free survival.	Time from date of inclusion to the event of tumor recurrence or clinical progression or radiological progression on primary tumor or on lymph nodes or on metastasis or death whatever the cause.	at 3 years after inclusion
Secondary	Prospective validation of the expression of interferon-gamma signature to predict overall survival.	Time from date of inclusion to death whatever the cause.	at 3 years after inclusion
Secondary	Prospective validation of the expression of interferon-gamma signature to predict duration of objective response.	Time from date of first observation of objective response to progressive disease according to RECIST v1.1 or death..	at 3 years after inclusion
Secondary	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.	objective response according to RECIST v1.1	at 3 months after initiation of immunotherapy
Secondary	Exploratory outcome : investigation of the expression of other molecular signatures such as immune checkpoints protein expression level to predict anti-PD1 immunotherapy response.	objective response according to RECIST v1.1	at 3 months after initiation of immunotherapy
Secondary	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.	objective response according to RECIST v1.1	at 3 months after initiation of immunotherapy
Secondary	Exploratory outcome : investigation of the expression of other molecular signatures such as protein expression level involved in hypoxia to predict anti-PD1 immunotherapy response.	objective response according to RECIST v1.1	at 3 months after initiation of immunotherapy