Occurrence of Adverse Effects With Immune Checkpoint Inhibitors Between a Single and Double Dose Regimen

Cancer Clinical Trial

— ICI DODO  

Official title:

Comparison of the Occurrence of Adverse Effects With Immune Checkpoint Inhibitors Between a Single and Double Dose Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04956783
• Other study ID #: RECHMPL21_0298
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Any adult patient with anti-PD-1 or PD-L-1 immune checkpoint inhibitor as monotherapy

Exclusion criteria:

• age < 18

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To describe the incidence	To describe the incidence, type and severity of overall toxicities (serious and non-serious) reported with single and double dose cancer immunotherapy regimens	18 months
Secondary	To identify risk factors for the development of severe toxicity	To identify risk factors for the development of severe toxicity	18 months
Secondary	To describe the management and evolution of toxicities	To describe the management and evolution of toxicities	18 months
Secondary	To describe the clinical oncologic response	To describe the clinical oncologic response	18 months