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

Recruiting

• Conditions: Head and Neck Cancer
• Interventions: Drug: Immunotherapy

• Registration Number: NCT05328024
• Lead Sponsor: Institut de cancérologie Strasbourg Europe

Brief 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.

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).

Study Timeline

• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-14
• Study Start: 2023-08-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22
• Primary Completion: 2029-08-25
• Study Completion: 2029-08-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Recurrent and/or metastatic head and neck carcinoma	Immunotherapy	Patients with indication of anti-PD1 immunotherapy according to recommendations

Primary Outcome Measures

Name	Time	Method
prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response.	at 3 months after initiation of immunotherapy	objective response according to iRECIST criteria (immune response evaluation criteria in solid tumours)

Secondary Outcome Measures

Name	Time	Method
Prospective validation of the expression of interferon-gamma signature to predict overall survival.	at 3 years after inclusion	Time from date of inclusion to death whatever the cause.
Prospective validation of the expression of interferon-gamma signature to predict duration of objective response.	at 3 years after inclusion	Time from date of first observation of objective response to progressive disease according to RECIST v1.1 or death..
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.	at 3 months after initiation of immunotherapy	objective response according to RECIST v1.1
Prospective validation of the expression of interferon-gamma signature to predict progression free survival.	at 3 years after inclusion	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.
Exploratory outcome : investigation of the expression of other molecular signatures such as protein expression level involved in hypoxia to predict anti-PD1 immunotherapy response.	at 3 months after initiation of immunotherapy	objective response according to RECIST v1.1
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.	at 3 months after initiation of immunotherapy	objective response according to RECIST v1.1
Exploratory outcome : investigation of the expression of other molecular signatures such as immune checkpoints protein expression level to predict anti-PD1 immunotherapy response.	at 3 months after initiation of immunotherapy	objective response according to RECIST v1.1

Trial Locations

Locations (1)

Institut de cancérologie Strasbourg Europe; 🇫🇷 Strasbourg, France