Evolution of the Heart Function When Monitoring Immunotherapies Anti-cancerous Inhibiting PD-1

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-09

Study Completion Date

2025-03-31

Brief Summary

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Prospective, monocentric clinical study. Patients selected for nivolumab therapy in AP-HM for melanoma and non-small cell lung cancer will be eligible. Do not include patients with conditions that do not allow MRI, prior cardiovascular disease with LVEF\<50%, cardiomyopathy, history of cardiac arrhythmia, history of cardiovascular toxicity under anticancer therapy, coronary artery disease or stroke less than 3 months Therapeutic management will not be modified and treatment will be administrated as usual.

Cardiovascular follow up will be identical to that recommended and realized in current care in the Cardio-Oncology unit of AP-HM. It will include clinical, biological (BNP and troponin) and trans-thoracic echocardiography (TTE) at baseline and then at 1, 3 and 6 months. Auto-antibodies against troponin I assay will be performed to avoid false negatives of normal blood level of troponin I at baseline and then at 6 months. Cardiac MRI will be performed as well at baseline and at the end of the study (6 months). MRI is the gold standard for ventricular function evaluation.

Primary endpoint will be left ventricular function evolution evaluated by global longitudinal strain (GLS, 2D speckles tracking) in TTE. Secondary endpoints will be left and right ventricular function parameters: LEVF by TTE and MRI, left ventricular indexed volumes by TTE and MRI, right ejection ventricular function and indexed volumes by TTE and MRI, systolic pulmonary arterial pressure by TTE, serum troponin I and BNP, arrhythmias and conduction disorders on the electrocardiogram (ECG).

Number of required subjects: GLS is recommended for following up left ventricular function under anticancer treatments. Based on the hypothesis of a significant GLS decrease (15%) in 20% of cases with alpha risk of 0.05 and accuracy of 0.12 which means expected confidence interval of 0.08-0.32, then the number of required subjects is 50 patients.

The inclusion period will be 18 months with a follow up if 6 months, ie a total duration of the study of 24 months.

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Detailed Description

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Conditions

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Melanoma Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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NIVOLUMAB PATIENTS

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

NIVOLUMAB

MRI

Intervention Type DEVICE

Cardiac MRI 6 MONTHS

BLOOD SAMPLES

Intervention Type BIOLOGICAL

biological (BNP and troponin)

trans-thoracic echocardiography

Intervention Type DEVICE

1, 3 and 6 months

Interventions

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Nivolumab

NIVOLUMAB

Intervention Type DRUG

MRI

Cardiac MRI 6 MONTHS

Intervention Type DEVICE

BLOOD SAMPLES

biological (BNP and troponin)

Intervention Type BIOLOGICAL

trans-thoracic echocardiography

1, 3 and 6 months

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

patients treated with nivolumab

Exclusion Criteria

* Age \<18 years
* Preliminary cardiac disease with FeVG \<50%
* Cardiomyopathy dilated, hypertrophic or restrictive
* History of cardiac arrhythmia
* History of cardiac toxicity under another anti-cancer treatment
* Known coronary disease
* History of stroke less than 3 months old
* Patient not wishing to participate in the study
* Vulnerable persons (pregnant women, adults under guardianship or guardianship, persons deprived of their liberty)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No