CancerTADIG-PNCT05973344
Understanding and Anticipating Therapeutic and ADverse Responses in Anti-cancer Immune Checkpoint Inhibition Towards a Better Therapeutic Management of Patients
An observational study of Cancer, run by University Hospital, Brest at 1 site in France.
Trial summary
The goal of this observational study is to explore the value of blood biomarkers for the purpose of predicting irAE development in cancer patients treated with immune checkpoint inihibitors (ICI) alone or in combination with other treatments (chemotherapy, radiotherapy and targeted therapy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 9 Feb 2024to 9 Feb 2030
- 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: All patients with tumors treated with ICI (anti-CTLA-4, anti-PD-1/PD-L1, LAG3, etc.) as standard-of-care, alone or in combination with other treatments (chemotherapy, radiotherapy and targeted therapy)
Who may be able to join
None listed.
Who cannot join
- Patient with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study
- Patient already receiving ICI
- Primary immunodeficiency and/or history of allogenic transplantation
- Current active infection
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection)
- Subject of guardianship (tutorship, curatorship)
- Active pregnancy
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
Brest University Hospital
Brest, 29200
Benjamin Auberger
About this study
The goal of this observational study is to explore the value of blood biomarkers for the purpose of predicting irAE development in cancer patients treated with immune checkpoint inihibitors (ICI) alone or in combination with other treatments (chemotherapy, radiotherapy and targeted therapy).
Data and blood samples will be collected from participants at different time points as part of routine follow-up visits. Data and blood samples will be analysed. Analysis will include the characterization of immune cells by mass and flow cytometry.
Read the detailed description
Advances in treating patients with immunotherapy have dramatically changed cancer morbidity and mortality. Immune checkpoint inhibitors (ICI), alone or combined with other treatments, are currently used both as standard of care or in experimental settings for various cancers. ICI treatment induces objective clinical responses in 20-40% of patients (varies by tumor type); however, this leaves a majority of patients that do not respond to ICI therapy. ICI drugs purposely release immune regulatory controls and consequently increase immune activities; however, this release also provokes a significant risk of immunerelated adverse events (irAEs) such as dermatitis, hepatitis, thyroiditis and colitis, and less frequently but clinically important, hypophysitis, myocarditis and pneumonia. While the incidence of irAE is highly variable and influenced by many factors, Phase I and II trials reported rates from 10% to 80% for any grade irAE while an irAE of grade 3 or higher was observed in 2.5% to 18% of subjects. Recently, Jing et al. demonstrated that 20% of patients receiving anti-PD-1/PD-L1 had at least one irAE by integrating real-world pharmacovigilance of 26 tumor types for a total of 18,706 patients. Presently, the specific immune mechanism(s) driving irAE are unknown and biomarkers that predict their onset, particularly high-grade irAE, are urgently needed. For this reason, we hypothesize that an in-depth characterization and comparisons of the cell subpopulations composing and interacting within the primary cancer lesions, the peripheral blood, and in the organs in which irAE arise could help to better understand but also predict the clinical therapeutic response or/and irAE in patients with advanced cancers treated with ICI.
The research is a non-interventional monocentric prospective study of humans for the development of biological and medical knowledge, in which the procedures are performed and the products used in the usual manner, without additional or unusual diagnostic, treatment or monitoring procedures. The study includes patients monitored for their cancer at CHU of Brest and treated using Immune Checkpoint Inhibitors. Data and peripheral blood (47mL) will be collected at different time points as part of routine follow-up visits for analysis. Analysis will include the characterization of immune cells by mass and flow cytometry.
- Conditions
- Cancer
- Keywords
- immunotherapy
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of irAE over the duration of the patient's follow-up
Apparition of irAE is appreciated according the physician definition. The description and grading scales of irAE found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0. A copy of the CTCAE version 5.0 can be downloaded from the CTEP web site http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm.
Measured: 36 months
Secondary outcomes (3)
Survival (PFS).
PFS is defined as the time from random assignment in the clinical trial to disease progression or death from any cause.
Measured: 36 months
Survival (OS).
OS is defined as the time from random assignment in the clinical trial to death.
Measured: 36 months
Tumor response according to the iRECIST criteria
A copy of the iRECIST can be downloaded from the Lancet Oncology web site: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30074-8/fulltext
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start9 Feb 2024
- Primary completion9 Feb 2030 (estimated)
- Study completion9 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Auberger, Principal investigator, CHU Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973344
- Sponsor's protocol ID
- 29BRC22.0189 (TADIG-P)
- Other IDs
- 2022-A02237-36
- Acronym
- TADIG-P
- Status last verified
- Jun 2026
- First submitted
- 24 Jul 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Anticipating Therapeutic and ADverse Responses in Anti-cancer Immune Checkpoint Inhibition Towards a Better Therapeutic Management of Patients
- ClinicalTrials.gov ID
- NCT05973344
- Acronym / sponsor ID
- TADIG-P / 29BRC22.0189 (TADIG-P)
- Conditions
- Cancer
- Keywords
- immunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 9 Feb 2030 (estimated)
- Study completion
- 9 Feb 2030 (estimated)
- First posted
- 2 Aug 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.
The goal of this observational study is to explore the value of blood biomarkers for the purpose of predicting irAE development in cancer patients treated with immune checkpoint inihibitors (ICI) alone or in combination with other treatments (chemotherapy, radiotherapy and targeted therapy).
Data and blood samples will be collected from participants at different time points as part of routine follow-up visits. Data and blood samples will be analysed. Analysis will include the characterization of immune cells by mass and flow cytometry.
Detailed description
Advances in treating patients with immunotherapy have dramatically changed cancer morbidity and mortality. Immune checkpoint inhibitors (ICI), alone or combined with other treatments, are currently used both as standard of care or in experimental settings for various cancers. ICI treatment induces objective clinical responses in 20-40% of patients (varies by tumor type); however, this leaves a majority of patients that do not respond to ICI therapy. ICI drugs purposely release immune regulatory controls and consequently increase immune activities; however, this release also provokes a significant risk of immunerelated adverse events (irAEs) such as dermatitis, hepatitis, thyroiditis and colitis, and less frequently but clinically important, hypophysitis, myocarditis and pneumonia. While the incidence of irAE is highly variable and influenced by many factors, Phase I and II trials reported rates from 10% to 80% for any grade irAE while an irAE of grade 3 or higher was observed in 2.5% to 18% of subjects. Recently, Jing et al. demonstrated that 20% of patients receiving anti-PD-1/PD-L1 had at least one irAE by integrating real-world pharmacovigilance of 26 tumor types for a total of 18,706 patients. Presently, the specific immune mechanism(s) driving irAE are unknown and biomarkers that predict their onset, particularly high-grade irAE, are urgently needed. For this reason, we hypothesize that an in-depth characterization and comparisons of the cell subpopulations composing and interacting within the primary cancer lesions, the peripheral blood, and in the organs in which irAE arise could help to better understand but also predict the clinical therapeutic response or/and irAE in patients with advanced cancers treated with ICI.
The research is a non-interventional monocentric prospective study of humans for the development of biological and medical knowledge, in which the procedures are performed and the products used in the usual manner, without additional or unusual diagnostic, treatment or monitoring procedures. The study includes patients monitored for their cancer at CHU of Brest and treated using Immune Checkpoint Inhibitors. Data and peripheral blood (47mL) will be collected at different time points as part of routine follow-up visits for analysis. Analysis will include the characterization of immune cells by mass and flow cytometry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with tumors treated with ICI (anti-CTLA-4, anti-PD-1/PD-L1, LAG3, etc.) as standard-of-care, alone or in combination with other treatments (chemotherapy, radiotherapy and targeted therapy)
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Patient with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study
- Patient already receiving ICI
- Primary immunodeficiency and/or history of allogenic transplantation
- Current active infection
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of irAE over the duration of the patient's follow-up
Time frame: 36 months
Apparition of irAE is appreciated according the physician definition. The description and grading scales of irAE found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0. A copy of the CTCAE version 5.0 can be downloaded from the CTEP web site http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm.
3 secondary outcomes
Survival (PFS).
Time frame: 36 months
Survival (OS).
Time frame: 36 months
Tumor response according to the iRECIST criteria
Time frame: 36 months
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 25 Sep 2026.
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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.
Benjamin Auberger principal investigator
CHU Brest
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 Cancer, run by University Hospital, Brest 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 0 inclusion and 7 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 25 Sep 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 Benjamin Auberger (+33298223740, benjamin.auberger@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of irAE over the duration of the patient's follow-up (time frame: 36 months). 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 25 Sep 2026.