Overview
Sponsor-declared trial summary
Cancer
To describe the evolution of left ventricular function in patients treated with nivolumab or pembrolizumab based on recommended monitoring data in a Cardio-Oncology unit.
Key facts
- Sponsor
- Centre Hospitalier Regional De Marseille
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 9 Apr 2018 → ongoing
- Decision date (initial)
- 2024-10-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517403-36-00
- EudraCT number
- 2017-001197-42
- ClinicalTrials.gov
- NCT03313544
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To describe the evolution of left ventricular function in patients treated with nivolumab or pembrolizumab based on recommended monitoring data in a Cardio-Oncology unit.
Secondary objectives 2
- Describe the evolution of right ventricular function in patients treated with nivolumab based on recommended monitoring data.
- Describe the evolution of cardiac rhythm in patients treated with nivolumab or pembrolizumab on the basis of recommended monitoring data.
Conditions and MedDRA coding
Cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- All patients selected to receive treatment with nivolumab or pembrolizumab in participating departments.
- patients affiliated to a national insurance scheme
Exclusion criteria 11
- Age < 18 years
- Pre-existing heart disease with FeVG <50
- Dilated, hypertrophic or restrictive cardiomyopathy
- History of cardiac arrhythmia
- History of cardiac toxicity on other anti-cancer treatments
- Known coronary artery disease
- History of stroke less than 3 months old
- Patient not wishing to participate in the study
- Vulnerable persons (pregnant women, adults under guardianship, persons deprived of liberty)
- Poor echogenicity, not amenable to echocardiography
- general condition not amenable to cardiac MRI.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Evolution of left ventricular function measured by the global longitudinal strain value.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SCP8265340 · ATC
- Active substance
- Nivolumab
- Substance synonyms
- BMS936558, ABP 206
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 480 mg milligram(s)
- Max total dose
- 480 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF01 — NIVOLUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP6094344 · ATC
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, BAT3306, Pabolizumab, FYB206, CT P51, SYS6036, QL-2107, ABP 234
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — PEMBROLIZUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Regional De Marseille
- Sponsor organisation
- Centre Hospitalier Regional De Marseille
- Address
- 80 Rue Brochier
- City
- Marseille
- Postcode
- 13005
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Regional De Marseille
- Contact name
- Cautela Jennifer
Public contact point
- Organisation
- Centre Hospitalier Regional De Marseille
- Contact name
- Cautela Jennifer
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 50 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2018-04-09 | 2018-04-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 2017-001197-42_PROTOCOLE_V6_20240531_IMMUNOCARD | 7 |
| Protocol (for publication) | D1_Protocol SOC_SM-1_IMMUNOCARD | 1 |
| Protocol (for publication) | D1_PROTOCOLE TC_2024-517403-36-00_IMMUNOCARD | 7 |
| Recruitment arrangements (for publication) | 2017-001197-42_Recruitment arrangements_IMMUNOCARD | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and informed consent procedure_IMMUNOCARD | 1 |
| Subject information and informed consent form (for publication) | 2017-001197-42_NIFC_V4_20240621_IMMUNOCARD | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 2017-001197-42_RCP EMA KEYTRUDA_13052024_IMMUNOCARD | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | 2017-001197-42_RCP EMA OPDIVO_14062024_IMMUNOCARD | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC TC _KEYTRUDA_IMMUNOCARD | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC TC _OPDIVO_IMMUNOCARD | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2024-517403-36-00_IMMUNOCARD | 3 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-19 | France | Acceptable 2024-10-02
|
2024-10-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-27 | France | Acceptable 2026-03-25
|
2026-04-01 |