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

NCT05328024 | Recruiting

• 1 other identifier: 2021-003
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Prospective validation of the expression of interferon-gamma signature to predict progression free survival.

  at 3 years after inclusion

• Prospective validation of the expression of interferon-gamma signature to predict overall survival.

  at 3 years after inclusion

• Prospective validation of the expression of interferon-gamma signature to predict duration of objective response.

  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.

  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.

  at 3 months after initiation of immunotherapy

Study Arms (1)

Recurrent and/or metastatic head and neck carcinoma

Patients with indication of anti-PD1 immunotherapy according to recommendations

Drug: Immunotherapy

Interventions

Immunotherapy DRUG

anti-PD1

Recurrent and/or metastatic head and neck carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de cancérologie Strasbourg Europe: lead
• Centre National de la Recherche Scientifique, France: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

RECRUITING

Related Publications (1)

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tumor and blood samples.

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Central Study Contacts

Valérie SARTORI

CONTACT

03 68 33 95 23; promotion-rc@icans.eu

Manon VOEGELIN

CONTACT

03 68 33 95 23; promotion-rc@icans.eu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: August 25, 2023
• Primary Completion (Estimated): August 25, 2029
• Study Completion (Estimated): August 25, 2029
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

FR (1)