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

June 4, 2026 updated by: Centre Paul Strauss
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
at 3 months after initiation of immunotherapy
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)
at 3 months after initiation of immunotherapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
at 3 years after inclusion
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.
at 3 years after inclusion
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..
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.
Time Frame: at 3 months after initiation of immunotherapy
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.
Time Frame: at 3 months after initiation of immunotherapy
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.
Time Frame: at 3 months after initiation of immunotherapy
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.
Time Frame: at 3 months after initiation of immunotherapy
objective response according to RECIST v1.1
at 3 months after initiation of immunotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Paul Strauss

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut National de la Santé Et de la Recherche Médicale, France
Centre National de la Recherche Scientifique, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 25, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 25, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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