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

NCT03313544 | Unknown Phase 4

• 2 other identifiers: 2017-012017-001197-42
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma; Non-small Cell; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• systolic pulmonary arterial pressure

  trans-thoracic echocardiography

  6 months

Secondary Outcomes (3)

• ventricular function evaluation.

  6 MONTHS

• serum troponin I

  1,3, 6 months

• Brain natriuretic peptide (BNP)

  1,3, 6 months

Study Arms (1)

NIVOLUMAB PATIENTS

EXPERIMENTAL

Drug: Nivolumab; Device: MRI; Biological: BLOOD SAMPLES; Device: trans-thoracic echocardiography

Interventions

Nivolumab DRUG

NIVOLUMAB

NIVOLUMAB PATIENTS

MRI DEVICE

Cardiac MRI 6 MONTHS

NIVOLUMAB PATIENTS

BLOOD SAMPLES BIOLOGICAL

biological (BNP and troponin)

NIVOLUMAB PATIENTS

trans-thoracic echocardiography DEVICE

1, 3 and 6 months

NIVOLUMAB PATIENTS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients treated with nivolumab

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

RECRUITING

Related Publications (1)

• Cadour F, Cautela J, Rapacchi S, Varoquaux A, Habert P, Arnaud F, Jacquier A, Meilhac A, Paganelli F, Lalevee N, Scemama U, Thuny F. Cardiac MRI Features and Prognostic Value in Immune Checkpoint Inhibitor-induced Myocarditis. Radiology. 2022 Jun;303(3):512-521. doi: 10.1148/radiol.211765. Epub 2022 Mar 1.

  PMID: 35230185 DERIVED

MeSH Terms

Conditions

Melanoma; Lung Neoplasms

Interventions

Nivolumab; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jean-Olivier ARNAUD

  assistance publique hôpitaux de marseille

  STUDY DIRECTOR

Central Study Contacts

jennifer CAUTELA

CONTACT

0491968289; jennifer.cautela@ap-hm.fr

ALEXANDRA GIULIANI

CONTACT

0491382747; drci@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 18, 2017
• Study Start: April 9, 2018
• Primary Completion: October 1, 2024
• Study Completion: March 1, 2025
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

FR (1)