Cancer19-916NCT04169503
Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events
An observational study of Cancer, run by University Hospital, Caen at 1 site in France.
Trial summary
Although immune checkpoint inhibitors (ICIs) have proved effective in treating many cancers, patients receiving ICIs may experience immune-related adverse events (irAEs). Little evidence exists on the safety of resuming these treatments after an irAE. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cancer
- What is being tested?
- Immune Checkpoint Modulator
- How many people
- 17,562 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2019to Feb 2020
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with immune checkpoint inhibitors and experiencing irAEs
Who may be able to join
- Case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,
- consecutive individual case safety reports present in VigiBase reporting an irAEs associated to at least one immune checkpoint inhibitor.
Who cannot join
- Chronology not compatible between the drug and the toxicity.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Alexandre Joachim
Caen, Basse Normandie, 14000
Joachim Alexandre, MD, +33231064670, alexandre-j@chu-caen.fr
About this study
Official title: Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events in Patients With Cancer: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database
Although immune checkpoint inhibitors (ICIs) have proved effective in treating many cancers, patients receiving ICIs may experience immune-related adverse events (irAEs). Little evidence exists on the safety of resuming these treatments after an irAE.
Our objective was to investigate the safety of ICI rechallenge after an irAE using the WHO pharmacovigilance database
- Conditions
- Cancer
- Being tested
- Immune Checkpoint Modulator
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Checkpoint ModulatorDrug
identification of cases of immune-related adverse events due to immune checkpoint inhibitors. Among these cases, identification and description of those with immune checkpoint inhibitor rechallenge.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of occurrence of second immune-related adverse events (irAEs)
percentage of cases experiencing a second irAE among the rechallenged cases
Measured: Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months).
Secondary outcomes (3)
Description of cases experiencing an initial irAEs
description of clinical features of cases experiencing an initial irAEs
Measured: Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months)..
Description of the rechallenge cases
description of clinical features of the rechallenged cases
Measured: Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months)..
Description of the clinical features of cases experiencing a second irAEs
Description of the clinical features of cases experiencing a second irAEs
Measured: Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months)..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start14 Oct 2019
- Primary completionJan 2020 (estimated)
- Study completionFeb 2020 (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, CaenThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 17,562 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169503
- Sponsor's protocol ID
- Pharmaco15-19-07
- Acronym
- 19-916
- Status last verified
- Jul 2019
- First submitted
- 19 Jul 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events in Patients With Cancer: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database
- ClinicalTrials.gov ID
- NCT04169503
- Acronym / sponsor ID
- 19-916 / Pharmaco15-19-07
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 17,562 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 20 Nov 2019 (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.
Although immune checkpoint inhibitors (ICIs) have proved effective in treating many cancers, patients receiving ICIs may experience immune-related adverse events (irAEs). Little evidence exists on the safety of resuming these treatments after an irAE.
Our objective was to investigate the safety of ICI rechallenge after an irAE using the WHO pharmacovigilance database
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with immune checkpoint inhibitors and experiencing irAEs
Key inclusion criteria (2 listed)
- Case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,
- consecutive individual case safety reports present in VigiBase reporting an irAEs associated to at least one immune checkpoint inhibitor.
Key exclusion criteria (1 listed)
- Chronology not compatible between the drug and the toxicity.
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 |
|---|---|---|
| Immune Checkpoint Modulatoridentification of cases of immune-related adverse events due to immune checkpoint inhibitors. Among these cases, identification and description of those with immune checkpoint inhibitor rechallenge. | Drug | – |
Primary outcome
Rate of occurrence of second immune-related adverse events (irAEs)
Time frame: Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months).
percentage of cases experiencing a second irAE among the rechallenged cases
3 secondary outcomes
Description of cases experiencing an initial irAEs
Time frame: Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months)..
Description of the rechallenge cases
Time frame: Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months)..
Description of the clinical features of cases experiencing a second irAEs
Time frame: Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months)..
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
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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. This study is not recruiting at the moment.
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, Caen 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: status not confirmed, as of the sponsor's last update on 20 Nov 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joachim Alexandre, MD (+33231064670, alexandre-j@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of occurrence of second immune-related adverse events (irAEs) (time frame: Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 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 20 Nov 2019.