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NCT Number: NCT03492242

Immune CHeckpoint Inhibitors Monitoring of Adverse Drug ReAction

Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events (irAEs) from rhumatologic, endocrinologic, cardiac or other system origin. This study investigates reports of drug induced irAEs with treatment including anti-PD1, Anti-PDL-1, and Anti-CTLA4 classes using the World Health Organization (WHO) database VigiBase and the french database Base Nationale de PharmacoVigilance (BNPV).

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Key information

Conditions

Arthritis Autoimmune Diseases Cancer Cardiac Disease Cardiovascular Diseases Endocrine System Diseases Eye Diseases Heart Diseases Immune System Diseases Joint Diseases Muscular Diseases Musculoskeletal Diseases Myositis Neoplasms Nervous System Diseases Neuromuscular Diseases Neuropathy Ophthalmopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.

Paris, 75013, France

About this study

Immune checkpoint inhibitors (ICIs) have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and used in combination. However, immune-related adverse events (irAEs) can occur. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, and in the Base Nationale de PharmacoVigilance (BNPV) which is the french pharmacovigilance database, to identify cases of adverse drug reaction including arthiritis, auto-immune induced diseases, cardiac diseases, endocrinologic diseases, following treatment with ICIs.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Case reported in the World Health Organization (WHO) database and Base Nationale de Pharmacovigilance (BNPV) of individual safety case reports to 01/05/2018
  • Adverse events reported
  • Patients treated with ICIs, in monotherapy or combination, included in the ATC: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32).

Exclusion criteria

  • Chronology not compatible between the drug and the toxicity

Treatment and study plan

Immune checkpoint inhibitor

Drug

Immune checkpoint inhibitor targeting either PD-1, PD-L1 or CTLA-4, and included in the following list (ATC classification) as a monotherapy or in combination: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32).

Primary outcomes

  1. Adverse drug reactions induced by ICIs and reported in the World Health Organization (WHO) or the Base Nationale de Pharmacovigilance (BNPV)

    Time frame: Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018

    Identification and report of cases of adverse events associated with ICIs. Drugs investigated are ICIs: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32).

Secondary outcomes

  1. Causality assessment of reported adverse drug reaction according to the WHO system

    Time frame: Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018

  2. Description of the type of adverse drug reaction depending on the category of ICIs

    Time frame: Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018

  3. Description of the other immune related adverse events concomitant to the adverse drug reaction induced by ICIs

    Time frame: Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018

  4. Description of the duration of treatment when the toxicity happens (role of cumulative dose)

    Time frame: Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018

  5. Description of the drug-drug interactions associated with adverse events

    Time frame: Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018

  6. Description of the pathologies (cancer) for which the incriminated drugs have been prescribed

    Time frame: Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018

  7. Description of the population of patients having adverse event

    Time frame: Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Monitoring of Immune Checkpoint Inhibitors Adverse Drug Reactions Through the WHO Vigilyze and French Pharmaco-vigilance Database (Base Nationale de Pharmacovigilance BNPV)

Acronym: CHIMeRA

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 10, 2018
Registry last updated
Sep 26, 2019

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.

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