Patients Recieving Anti-PD-1 or Anti-PD-L1 ImmunotherapiesImmunEONCT04609930
Impact of Immune Checkpoint Inhibitor Therapy on Type 2 Inflammation
An observational study of Patients Recieving Anti-PD-1 or Anti-PD-L1 Immunotherapies, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The primary objective of this study is to determine the impact of anti-checkpoint immunotherapy on type 2 inflammation via a retrospective analysis of % eosinophilia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients Recieving Anti-PD-1 or Anti-PD-L1 Immunotherapies
- What is being tested?
- Anti-PD-1 or anti-PD-L1
- How many people
- 143 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2020to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population corresponds to all patients within the University Hospitals of Montpellier system who received anti-PDF-1 and/or anti-PD-L1 immunotherapies.
Who may be able to join
- Electronic patient file "DxCare" at the University Hospitals of Montpellier
- Patient has received anti-PD-1 immunotherapy --AND/OR -- anti-PD-L1 immunotherapy according to central pharmacy records
Who cannot join
- No mention of % eosinophilia in the patient file
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to determine the impact of anti-checkpoint immunotherapy on type 2 inflammation via a retrospective analysis of % eosinophilia.
- Being tested
- Anti-PD-1 or anti-PD-L1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-PD-1 or anti-PD-L1Drug
Immunotherapy treatment via anti programmed death 1 and/or anti-programmed death ligand 1.
| Study group | Role | What they receive |
|---|---|---|
| The study population | Patients in the University Hospitals of Montpellier system who have received anti-PD-1 and/or anti-PD-L1 Receives: Drug: Anti-PD-1 or anti-PD-L1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
Measured: Before treatment (before day 0) versus after (15 days)
Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
Measured: Before treatment (before day 0) versus after (1 month)
Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
Measured: Before treatment (before day 0) versus after (3 months)
Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
Measured: Before treatment (before day 0) versus after (6 months)
Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
Measured: Before treatment (before day 0) versus after (12 months)
Secondary outcomes (3)
Indication leading to anti-PD-1 and/or anti-PD-L1 immunotherapies
Name of pathology
Measured: Day 0
Age (years)
Measured: Day 0
Sex (male/female)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start30 Oct 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Recieving Anti-PD-1 or Anti-PD-L1 ImmunotherapiesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Retrospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremy Charriot, MD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609930
- Sponsor's protocol ID
- RECHMPL20_0583
- Acronym
- ImmunEO
- Status last verified
- Nov 2021
- First submitted
- 26 Oct 2020
- Last updated
- 23 Dec 2021
- 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 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Immune Checkpoint Inhibitor Therapy on Type 2 Inflammation
- ClinicalTrials.gov ID
- NCT04609930
- Acronym / sponsor ID
- ImmunEO / RECHMPL20_0583
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 30 Oct 2020 (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 primary objective of this study is to determine the impact of anti-checkpoint immunotherapy on type 2 inflammation via a retrospective analysis of % eosinophilia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Drug: Anti-PD-1 or anti-PD-L1Patients in the University Hospitals of Montpellier system who have received anti-PD-1 and/or anti-PD-L1 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population corresponds to all patients within the University Hospitals of Montpellier system who received anti-PDF-1 and/or anti-PD-L1 immunotherapies.
Key inclusion criteria (2 listed)
- Electronic patient file "DxCare" at the University Hospitals of Montpellier
- Patient has received anti-PD-1 immunotherapy --AND/OR -- anti-PD-L1 immunotherapy according to central pharmacy records
Key exclusion criteria (1 listed)
- No mention of % eosinophilia in the patient file
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 |
|---|---|---|
| Anti-PD-1 or anti-PD-L1Immunotherapy treatment via anti programmed death 1 and/or anti-programmed death ligand 1. | Drug | The study population |
Primary outcome
Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
Time frame: Before treatment (before day 0) versus after (15 days)
Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
Time frame: Before treatment (before day 0) versus after (1 month)
Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
Time frame: Before treatment (before day 0) versus after (3 months)
Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
Time frame: Before treatment (before day 0) versus after (6 months)
Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1
Time frame: Before treatment (before day 0) versus after (12 months)
3 secondary outcomes
Indication leading to anti-PD-1 and/or anti-PD-L1 immunotherapies
Time frame: Day 0
Age (years)
Time frame: Day 0
Sex (male/female)
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Jeremy Charriot, MD study director
University Hospital, Montpellier
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 Patients Recieving Anti-PD-1 or Anti-PD-L1 Immunotherapies, run by University Hospital, Montpellier 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 23 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1 (time frame: Before treatment (before day 0) versus after (15 days)). The study lists 5 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 23 Dec 2021.