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NCT Number: NCT05328024

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut de cancérologie Strasbourg Europe

Strasbourg, France, 67033

Location status: Recruiting

Location contact

Mickaël BURGY

CONTACT

Mickaël BURGY

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunotherapy

Drug

anti-PD1

Primary outcomes

  1. prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response.

    Time frame: at 3 months after initiation of immunotherapy

    objective response according to RECIST v1.1 (response evaluation criteria in solid tumours)

  2. prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response.

    Time frame: at 3 months after initiation of immunotherapy

    objective response according to iRECIST criteria (immune response evaluation criteria in solid tumours)

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: at 3 years after inclusion

    Time from date of inclusion to death whatever the cause.

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

    Time frame: at 3 years after inclusion

    Time from date of first observation of objective response to progressive disease according to RECIST v1.1 or death..

  4. 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

    objective response according to RECIST v1.1

  5. 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

    objective response according to RECIST v1.1

  6. 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

    objective response according to RECIST v1.1

  7. 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

    objective response according to RECIST v1.1

Study contacts

Contact information is provided by the study sponsor or research team.

Manon VOEGELIN

CONTACT

[email protected]

03 68 33 95 23

Valérie SARTORI

CONTACT

[email protected]

03 68 33 95 23

Sponsors and collaborators

Lead sponsor

Centre Paul Strauss

Other

Collaborators

  • Centre National de la Recherche Scientifique, France
  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Acronym: IPRICE

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Apr 14, 2022
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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