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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04956783

Acronym

ICI DODO

Enrollment

500

Registered

2021-07-09

Start date

2021-06-01

Completion date

2021-06-30

Last updated

2021-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

\- age \< 18

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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

Countries

France

Outcome results