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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: Immunotherapy

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Manon VOEGELIN; Phone Number: 03 68 33 95 23; Email: promotion-rc@icans.eu
• Study Contact Backup: Name: Valérie SARTORI; Phone Number: 03 68 33 95 23; Email: promotion-rc@icans.eu

Study Locations

• France
  • France
    • Strasbourg, France, France, 67033
      • Recruiting
      • Institut de cancérologie Strasbourg Europe
      • Principal Investigator: Mickaël BURGY
      • Contact: Mickaël BURGY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with recurrent or metastatic squamous-cell carcinoma of the head and neck not amenable to local therapy and/or with metastatic disease and with an indication to treatment by anti-PD1 immunotherapy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Recurrent and/or metastatic head and neck carcinoma; Patients with indication of anti-PD1 immunotherapy according to recommendations	Drug: Immunotherapy; anti-PD1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Centre Paul Strauss
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Centre National de la Recherche Scientifique, France

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Estimated): August 25, 2029
• Study Completion (Estimated): August 25, 2029

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Therapeutics; Biological Therapy; Immunomodulation; Immunotherapy
• Other Study ID Numbers: 2021-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No