Evolution of the cardiac function(office) during the follow-up of the anticancer immunotherapy inhibiting PD-1

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001197-42-FR

Enrollment

Registered

2017-06-27

Start date

2017-05-15

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

as melanoma, non-small cell lung cancers and kidney cancers

Interventions

Trade Name: opdivo Product Name: nivolumab Product Code: nivolumab Pharmaceutical Form: Concentrate for solution for infusion Current Sponsor code: NIVOLUMAB Other descriptive name: NIVOLUMAB Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - patients selected to receive a treatment by nivolumab in the departments participating - affiliated to a national insurance scheme. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Mediocre Echogénicité not allowing the realization of an echocardiography and a general state not allowing the realization of a cardiac MRI.

Design outcomes

Primary

Measure	Time frame
Main Objective: Describe cardiac function evolution in patients treated with nivolumab.;Secondary Objective: ;Primary end point(s): Primary endpoint will be left ventricular function evolution evaluated by global longitudinal strain (GLS, 2D speckles tracking) in TTE;Timepoint(s) of evaluation of this end point: 6 months	—

Secondary

Measure	Time frame
Secondary end point(s): 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).;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Secondary end point(s): 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).;Timepoint(s) of evaluation of this end point: 6 months

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Countries

France

Contacts

Public ContactAgnelli

assistance publique hopitaux de marseille

lauren.agnelli@ap-hm.fr04 91 38 27 47

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026