Clinical trial • Phase IV • Oncology
Pembrolizumab for Cancer
Phase IV trial of Pembrolizumab for Cancer. 50 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Cancer
- Trial Stage
- Phase IV
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 19-09-2024
- First CTIS Authorization Date
- 07-10-2024
Trial design
Phase IV trial across 1 site in France.
- Target Sample Size
- 50
Eligibility
Recruits 50 Vulnerable persons (pregnant women, adults under guardianship, persons deprived of liberty) are listed in the exclusion criteria. No further details on consent/assent handling for vulnerable populations are provided in the available metadata..
- Pregnancy Exclusion
- Vulnerable persons (pregnant women, adults under guardianship, persons deprived of liberty)
- Vulnerable Population
- Vulnerable persons (pregnant women, adults under guardianship, persons deprived of liberty) are listed in the exclusion criteria. No further details on consent/assent handling for vulnerable populations are provided in the available metadata.
Inclusion criteria
- {"criterion_text":"- All patients selected to receive treatment with nivolumab or pembrolizumab in participating departments."}
- {"criterion_text":"- patients affiliated to a national insurance scheme"}
Exclusion criteria
- {"criterion_text":"- Age < 18 years"}
- {"criterion_text":"- Poor echogenicity, not amenable to echocardiography"}
- {"criterion_text":"- general condition not amenable to cardiac MRI."}
- {"criterion_text":"- Pre-existing heart disease with FeVG <50"}
- {"criterion_text":"- Dilated, hypertrophic or restrictive cardiomyopathy"}
- {"criterion_text":"- History of cardiac arrhythmia"}
- {"criterion_text":"- History of cardiac toxicity on other anti-cancer treatments"}
- {"criterion_text":"- Known coronary artery disease"}
- {"criterion_text":"- History of stroke less than 3 months old"}
- {"criterion_text":"- Patient not wishing to participate in the study"}
- {"criterion_text":"- Vulnerable persons (pregnant women, adults under guardianship, persons deprived of liberty)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Evolution of left ventricular function measured by the global longitudinal strain value.","definition_or_measurement_approach":"Measured by the global longitudinal strain value, based on recommended monitoring data in a Cardio-Oncology unit."}
Recruitment
- Planned Sample Size
- 50
- Recruitment Window Months
- 125
- Consent Approach
- Subject information and informed consent form documents are listed in the trial documents (e.g. '2017-001197-42_NIFC_V4_20240621_IMMUNOCARD'), but no metadata is provided describing who provides consent, age-specific assent procedures, or available languages in the provided records.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 50
France
- Earliest CTIS Part Ii Submission Date
- 20-08-2024
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 589
- Number Of Sites
- 1
- Number Of Participants
- 50
Sites
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Cardiologie
- Principal Investigator Name
- Jennifer Cautela
- Principal Investigator Email
- jennifer.cautela@ap-hm.fr
- Contact Person Name
- Jennifer Cautela
- Contact Person Email
- jennifer.cautela@ap-hm.fr
- Number Of Participants
- 50
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Regional De Marseille
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- PEMBROLIZUMAB
- Active Substance
- Pembrolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 400 mg
- Investigational Product Name
- NIVOLUMAB
- Active Substance
- Nivolumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 480 mg
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