Occurrence of Adverse Effects With Immune Checkpoint Inhibitors Between a Single and Double Dose Regimen
- Conditions
- Cancer
- Registration Number
- NCT04956783
- Lead Sponsor
- University Hospital, Montpellier
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the incidence of clinical significant toxicities 18 months 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
- Secondary Outcome Measures
Name Time Method To describe the management and evolution of toxicities 18 months To describe the management and evolution of toxicities
To describe the clinical oncologic response 18 months To describe the clinical oncologic response
To describe the incidence 18 months To describe the incidence, type and severity of overall toxicities (serious and non-serious) reported with single and double dose cancer immunotherapy regimens
To identify risk factors for the development of severe toxicity 18 months To identify risk factors for the development of severe toxicity
Trial Locations
- Locations (1)
Uhmontpellier
🇫🇷Montpellier, France