NCT04586894

Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors

Atteintes Myocardiques, péricardiques et Vasculaires Sous Simple et/ou Double immunothérapie Anti-cancéreuse Anti-PD1, antiPDL1 et Anti-CTLA4

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Our knowledge on cardiovascular side effects of immune checkpoint inhibitors (ICIs) is restricted to this date to observational retrospective data (mainly case series and pharamcovigilance analysis). We aim at assessing the incidence of cardiovascular adverse side effects of ICIs by means of a prospective interventional single centre study using multiple biomarkers.

Detailed description

Immune checkpoint inhibitors (ICIs) are drastically improving cancer prognosis. Cardiovascular adverse side effects of ICIs are though to be rare but may be responsible for \~50% death rates. Prospective screening for cardiovascular and muscular immune related side effects has not been undertaken independently from the industry. The aim is to describe the incidence of these side effects by means of serial assessment in patients undergoing ICI therapy for cancer. Biomarkers as ECG, echocardiography, cardiac magnetic resonance imaging and long-term ECG monitoring will be undertaken at inclusion (before ICI therapy is started), and during the first cycle treatments and at 6 months follow-up. Mean endpoint encompasses cardiovascular and muscular adverse side effects between the 2nd and the 3rd ICI cycle. Secondary endpoints include cardiovascular and muscular adverse side effects at 6 months follow-up, and the incidence of individual side effects. 4 ancillary studies based on patients' blood biobanking are also planned. Their objectives are: * to assess sensitivity of heart failure biomarkers in predicting cardiovascular events under ICI, * to assess sensitivity of cytokine biomarkers in predicting cardiovascular events under ICI, * to bank cells to induce cardiomyocytes from stem cells * to bank DNA to identify genetic factors related to occurrence of cardiovascular events under ICI

Conditions

• Cancer
• Immune Defect
• Cardiovascular Abnormalities

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cardiac MRI	Gadolinium-enhanced magnetic resonance imaging of the heart before the first cycle of chemotherapy
DEVICE	Smart cloth	A smart cloth recording cardiac and hemodynamic parameters will be worn by patients during 42 days. Replaced by a holter monitor if the smart cloth is refused or not tolerated by the patient.
OTHER	Biobanking	Blood samples (plasma, serum, DNA, stem cells, immune cells) taken as part of the study will be stored in a biological sample collection. These samples may be used for further analysis not described in the initial protocol but which may be useful for investigation or in light of advances in scientific knowledge.

Timeline

• Start date: 2020-11-06
• Primary completion: 2022-02-01
• Completion: 2022-07-01
• First posted: 2020-10-14
• Last updated: 2023-06-08

Locations

1 site across 1 country: France