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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03313544
Recruitment Status : Not yet recruiting
First Posted : October 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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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.


Condition or disease Intervention/treatment Phase
Melanoma Non-small Cell Lung Cancer Drug: Nivolumab Device: MRI Biological: BLOOD SAMPLES Device: trans-thoracic echocardiography Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evolution of the Heart Function When Monitoring Immunotherapies Anti-cancerous Inhibiting Programmed Cell Death 1 (PD-1)
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: NIVOLUMAB PATIENTS Drug: Nivolumab
NIVOLUMAB

Device: MRI
Cardiac MRI 6 MONTHS

Biological: BLOOD SAMPLES
biological (BNP and troponin)

Device: trans-thoracic echocardiography
1, 3 and 6 months


Outcome Measures
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Primary Outcome Measures :
  1. systolic pulmonary arterial pressure [ Time Frame: 6 months ]
    trans-thoracic echocardiography


Secondary Outcome Measures :
  1. ventricular function evaluation. [ Time Frame: 6 MONTHS ]
    MRI

  2. serum troponin I [ Time Frame: 1,3, 6 months ]
    BLOOD SAMPLES

  3. Brain natriuretic peptide (BNP) [ Time Frame: 1,3, 6 months ]
    BLOOD SAMPLES


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313544


Contacts
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Contact: jennifer CAUTELA 0491968289 jennifer.cautela@ap-hm.fr
Contact: ALEXANDRA GIULIANI 0491382747 drci@ap-hm.fr

Locations
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France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Contact: JENNIFER CAUTELA       jennifer.cautela@ap-hm.fr   
Principal Investigator: jennifer CAUTELA         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Jean-Olivier ARNAUD assistance publique hôpitaux de marseille
More Information
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03313544    
Other Study ID Numbers: 2017-01
2017-001197-42 ( EudraCT Number )
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Nerve Tissue
Nevi and Melanomas
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents