Skip to main content
OpenTrials
Completed

NCT Number: NCT04956783

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • age < 18

Treatment and study plan

Primary outcomes

  1. To compare the incidence of clinical significant toxicities

    Time frame: 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 outcomes

  1. To describe the incidence

    Time frame: 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

  2. To identify risk factors for the development of severe toxicity

    Time frame: 18 months

    To identify risk factors for the development of severe toxicity

  3. To describe the management and evolution of toxicities

    Time frame: 18 months

    To describe the management and evolution of toxicities

  4. To describe the clinical oncologic response

    Time frame: 18 months

    To describe the clinical oncologic response

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: ICI DODO

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 9, 2021
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.