Occurrence of Adverse Effects With Immune Checkpoint Inhibitors Between a Single and Double Dose Regimen
ICI DODO
Comparison of the Occurrence of Adverse Effects With Immune Checkpoint Inhibitors Between a Single and Double Dose Regimen
1 other identifier
observational
500
1 country
1
Brief Summary
This is a retrospective evaluation of the impact of a double dose regimen of immunotherapy use in cancer treatment compared to the single-dose regimen on the occurrence of clinically significant adverse events. The aim of this study is to provide evidence-based arguments to help clinicians to propose the best treatment regimen for each patient.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
June 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedFirst Posted
Study publicly available on registry
July 9, 2021
CompletedJuly 20, 2021
June 1, 2021
29 days
June 30, 2021
July 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
To compare the incidence of clinical significant toxicities
To compare the incidence of clinical significant toxicities reported for patients treated with a cancer immunotherapy on a simple dose regiment versus double dose regimen
18 months
Secondary Outcomes (4)
To describe the incidence
18 months
To identify risk factors for the development of severe toxicity
18 months
To describe the management and evolution of toxicities
18 months
To describe the clinical oncologic response
18 months
Eligibility Criteria
Any adult patient (over the age of 18) from Montpellier University Hospital or Montpellier Cancer Institute who has initiated an immunotherapy between 01/01/2019 and 31/12/2020 with anti-PD-1 or PD-L-1 immune checkpoint inhibitor as monotherapy (nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab)
You may qualify if:
- \- Any adult patient with anti-PD-1 or PD-L-1 immune checkpoint inhibitor as monotherapy
You may not qualify if:
- \- age \< 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uhmontpellier
Montpellier, 34295, France
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandre Maria, MD
University Hospital, Montpellier
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2021
First Posted
July 9, 2021
Study Start
June 1, 2021
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
July 20, 2021
Record last verified: 2021-06