ImmunotherapyIbe2i-TIPCINCT05813418
Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients Undergoing Immune CheckPoint Inhibitors (ICPI) Treatment
A study testing blood retriewal in people with Immunotherapy and Immune Checkpoint Inhibitors, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
In the last decades, cancer treatment was based on surgery, radiotherapy and chemotherapy. Recently, treatments have largely evolved, first with targeted therapies (notably tyrosin kinase inhibitors, TKI) and then with immune checkpoint inhibitors (ICPI, notably anti-CTLA-4 and anti- PD1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunotherapy, Immune Checkpoint Inhibitors, Immune-related Adverse Event
- What is being tested?
- blood retriewal
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2021to Dec 2025
- Phase
- Interventional
- 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
Who may be able to join
- patient with cancer, whatever initial tumoral histology and disease stage under ICPI treatment (anti-PD1 and/or anti-CTLA-4)
- age > 18
- followed in oncology, pneumology, dermatology, gastroenterology departments of Amiens-Picardie University Hospital or Saint Quentin hospital
- who received verbal and written information, and signed the consent form for the study
Who cannot join
- non ICPI treated patients
- patient who received a first line of ICPI treatment
- patient who received or is receiving MEK inhibitors as a treatment (because of possible lower response to ICPI treatment when associated)
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
CHU Amiens Picardie
Amiens, Picardie, 80054
Gwladys BOURDENET, Dr, 03.22.08.70.72, bourdenet.gwladys@chu-amiens.fr
Aurélie MOREIRA, MD
About this study
Official title: Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients
In the last decades, cancer treatment was based on surgery, radiotherapy and chemotherapy.
Recently, treatments have largely evolved, first with targeted therapies (notably tyrosin kinase inhibitors, TKI) and then with immune checkpoint inhibitors (ICPI, notably anti-CTLA-4 and anti- PD1). The last ones can induce durable anti-tumoral responses in patients, even if metastases are present. Their mechanisms of action are focused on the activation of immune system in order to eliminate the tumor. ICPI, because of their mechanisms of action, target immune tolerance key components and can induce important immune toxicities (colitis, hepatitis, dermatitis, thyroiditis ...), leading to early discontinuation of treatment, severe or chronic morbidity, and can sometimes be lethal. It is of importance to detect patient at risk of irAEs, because of the increasing use of ICPI and the long- term response capacity in treated patients.
- Conditions
- Immunotherapy, Immune Checkpoint Inhibitors, Immune-related Adverse Event, Predictive Biomarkers
- Being tested
- blood retriewal
- Keywords
- immunotherapy, immune checkpoint inhibitors, Immune-related Adverse Event, predictive biomarkers, plasmatic cytokines, circulating immune subpopulations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood retriewalBiological
blood retriewal for cytokine concentration measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation from baseline of IL6 concentration in riAEs patients
Variation from baseline of IL6 concentration (pG/mL) in riAEs patients
Measured: 6 months
Variation from baseline of IL10 concentration in riAEs patients
Variation from baseline of IL10 concentration (pG/mL) in riAEs patients
Measured: 6 months
Variation from baseline of IL15 concentration in riAEs patients
Variation from baseline of IL15 concentration (pG/mL) in riAEs patients
Measured: 6 months
Variation from baseline of IL8 concentration in riAEs patients
Variation from baseline of IL8 concentration (pG/mL) in riAEs patients
Measured: 6 months
Variation from baseline of INFgamma concentration in riAEs patients
Variation from baseline of INFgamma concentration (pG/mL) in riAEs patients
Measured: 6 months
Variation from baseline of MCP-1 concentration in riAEs patients
Variation from baseline of MCP-1 concentration (pG/mL) in riAEs patients
Measured: 6 months
Variation from baseline of MIP 1 alpha concentration in riAEs patients
Variation from baseline of MIP 1 alpha concentration (pG/mL) in riAEs patients
Measured: 6 months
Variation from baseline of MIP 1 beta concentration in riAEs patients
Variation from baseline of MIP 1 beta concentration (pG/mL) in riAEs patients
Measured: 6 months
Variation from baseline of sIL2R concentration in riAEs patients
Variation from baseline of sIL2R concentration (U/mL) in riAEs patients
Measured: 6 months
Variation from baseline of sIL6R concentration in riAEs patients
Variation from baseline of sIL6R concentration (µG/mL) in riAEs patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start2 Jul 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunotherapyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Central Hospital Saint Quentin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813418
- Sponsor's protocol ID
- PI2019_843_0078
- Acronym
- Ibe2i-TIPCI
- Status last verified
- Jun 2025
- First submitted
- 3 Apr 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients
- ClinicalTrials.gov ID
- NCT05813418
- Acronym / sponsor ID
- Ibe2i-TIPCI / PI2019_843_0078
- Conditions
- Immunotherapy, Immune Checkpoint Inhibitors, Immune-related Adverse Event, Predictive Biomarkers
- Keywords
- immunotherapy, immune checkpoint inhibitors, Immune-related Adverse Event, predictive biomarkers, plasmatic cytokines, circulating immune subpopulations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Central Hospital Saint Quentin
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Apr 2023 (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.
In the last decades, cancer treatment was based on surgery, radiotherapy and chemotherapy.
Recently, treatments have largely evolved, first with targeted therapies (notably tyrosin kinase inhibitors, TKI) and then with immune checkpoint inhibitors (ICPI, notably anti-CTLA-4 and anti- PD1). The last ones can induce durable anti-tumoral responses in patients, even if metastases are present. Their mechanisms of action are focused on the activation of immune system in order to eliminate the tumor. ICPI, because of their mechanisms of action, target immune tolerance key components and can induce important immune toxicities (colitis, hepatitis, dermatitis, thyroiditis ...), leading to early discontinuation of treatment, severe or chronic morbidity, and can sometimes be lethal. It is of importance to detect patient at risk of irAEs, because of the increasing use of ICPI and the long- term response capacity in treated patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient with cancer, whatever initial tumoral histology and disease stage under ICPI treatment (anti-PD1 and/or anti-CTLA-4)
- age > 18
- followed in oncology, pneumology, dermatology, gastroenterology departments of Amiens-Picardie University Hospital or Saint Quentin hospital
- who received verbal and written information, and signed the consent form for the study
Key exclusion criteria (3 listed)
- non ICPI treated patients
- patient who received a first line of ICPI treatment
- patient who received or is receiving MEK inhibitors as a treatment (because of possible lower response to ICPI treatment when associated)
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 |
|---|---|---|
| blood retriewalblood retriewal for cytokine concentration measurement | Biological | – |
Primary outcome
Variation from baseline of IL6 concentration in riAEs patients
Time frame: 6 months
Variation from baseline of IL6 concentration (pG/mL) in riAEs patients
Variation from baseline of IL10 concentration in riAEs patients
Time frame: 6 months
Variation from baseline of IL10 concentration (pG/mL) in riAEs patients
Variation from baseline of IL15 concentration in riAEs patients
Time frame: 6 months
Variation from baseline of IL15 concentration (pG/mL) in riAEs patients
Variation from baseline of IL8 concentration in riAEs patients
Time frame: 6 months
Variation from baseline of IL8 concentration (pG/mL) in riAEs patients
Variation from baseline of INFgamma concentration in riAEs patients
Time frame: 6 months
Variation from baseline of INFgamma concentration (pG/mL) in riAEs patients
Variation from baseline of MCP-1 concentration in riAEs patients
Time frame: 6 months
Variation from baseline of MCP-1 concentration (pG/mL) in riAEs patients
Variation from baseline of MIP 1 alpha concentration in riAEs patients
Time frame: 6 months
Variation from baseline of MIP 1 alpha concentration (pG/mL) in riAEs patients
Variation from baseline of MIP 1 beta concentration in riAEs patients
Time frame: 6 months
Variation from baseline of MIP 1 beta concentration (pG/mL) in riAEs patients
Variation from baseline of sIL2R concentration in riAEs patients
Time frame: 6 months
Variation from baseline of sIL2R concentration (U/mL) in riAEs patients
Variation from baseline of sIL6R concentration in riAEs patients
Time frame: 6 months
Variation from baseline of sIL6R concentration (µG/mL) in riAEs patients
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 4 Jun 2025.
- Individual participant dataSharing planned: No
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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?
A study testing blood retriewal in people with Immunotherapy and Immune Checkpoint Inhibitors, run by Centre Hospitalier Universitaire, Amiens 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 4 inclusion and 3 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 4 Jun 2025. 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 Gwladys BOURDENET, DR (03.22.08.70.72, bourdenet.gwladys@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation from baseline of IL6 concentration in riAEs patients (time frame: 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2025.