Head and Neck CancerIPRICENCT05328024
Identification of Predictive Factors for the Response to Anti-Programmed Cell Death Protein 1 (PD1) Immunotherapy in Head and Neck Squamous Cell Carcinoma
An observational study of Head and Neck Cancer, run by Centre Paul Strauss at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Immunotherapy
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 25 Aug 2023to 25 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut de cancérologie Strasbourg Europe
Strasbourg, France, 67033
Mickaël BURGY
Mickaël BURGY
About this study
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.
Read the 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).
- Conditions
- Head and Neck Cancer
- Being tested
- Immunotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunotherapyDrug
anti-PD1
| Study group | Role | What they receive |
|---|---|---|
| Recurrent and/or metastatic head and neck carcinoma | Patients with indication of anti-PD1 immunotherapy according to recommendations Receives: Drug: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: at 3 months after initiation of immunotherapy
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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..
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at 3 months after initiation of immunotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start25 Aug 2023
- Primary completion25 Aug 2029 (estimated)
- Study completion25 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328024
- Sponsor's protocol ID
- 2021-003
- Acronym
- IPRICE
- Status last verified
- Jun 2026
- First submitted
- 7 Apr 2022
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 38066522
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictive Factors for the Response to Anti-Programmed Cell Death Protein 1 (PD1) Immunotherapy in Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05328024
- Acronym / sponsor ID
- IPRICE / 2021-003
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 25 Aug 2029 (estimated)
- Study completion
- 25 Aug 2029 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recurrent and/or metastatic head and neck carcinoma | – | Drug: ImmunotherapyPatients with indication of anti-PD1 immunotherapy according to recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunotherapyanti-PD1 | Drug | Recurrent and/or metastatic head and neck carcinoma |
Primary outcome
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)
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)
7 secondary outcomes
Prospective validation of the expression of interferon-gamma signature to predict progression free survival.
Time frame: 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
Prospective validation of the expression of interferon-gamma signature to predict duration of objective response.
Time frame: 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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Derived from this study: PubMed 38066522Helene 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Centre Paul Strauss at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie SARTORI (03 68 33 95 23, promotion-rc@icans.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response. (time frame: at 3 months after initiation of immunotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05328024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.