Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
1,000
Countries
1
Sites
1
non small cell lung cancer (NSCLC)
In this study, we aim to investigate the cardiovascular side effects of immune checkpoint inhibitors.
Key facts
- Sponsor
- Semmelweis University
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Jan 2026 → ongoing
- Decision date (initial)
- 2026-01-14
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Prophylaxis, Diagnosis
In this study, we aim to investigate the cardiovascular side effects of immune checkpoint inhibitors.
Conditions and MedDRA coding
non small cell lung cancer (NSCLC)
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-523620-44-01 | BudapestICIVasc: Cardiovascular side effects of immune checkpoint inhibitor oncological therapies and their monitoring in the context of onco-cardiology | Semmelweis University |
| 2025-523620-44-00 | BudapestICIVasc: Cardiovascular side effects of immune checkpoint inhibitor oncological therapies and their monitoring in the context of onco-cardiology | Semmelweis University |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patients presented to the oncology teams of Semmelweis University and clinics in the country wishing to join the research
- Planned immune checkpoint inhibitor therapy
- At least 18 years of age
- Signing of the patient information sheet and consent form by the patient
- Accessible medical history
Exclusion criteria 4
- Lack of informed consent form
- Age under 18
- Illiteracy
- Pregnancy and breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is defined as a 5-point MACE composite endpoint, which includes the following events: • cardiovascular death, • non-fatal myocardial infarction, • non-fatal stroke, • unstable angina requiring hospitalization and/or urgent coronary revascularization, • hospitalization due to heart failure.
Secondary endpoints 1
- For a detailed assessment of the cardiovascular safety of the treatment, the following events will be analyzed as secondary endpoints: • newly developing or worsening arterial hypertension; • cardiac arrhythmias; • venous thromboembolic events; • other clinically relevant cardiovascular adverse events; • hospitalization for cardiac reasons, if not part of the MACE composite event defined as the primary endpoint
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
YERVOY 5 mg/ml concentrate for solution for infusion
PRD2341715 · Product
- Active substance
- Ipilimumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 1 mg/kg milligram(s)/kilogram
- Max total dose
- 1 mg/kg milligram(s)/kilogram
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FX04 — -
- Marketing authorisation
- EU/1/11/698/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion.
PRD12081132 · Product
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, BAT3306, Pabolizumab, FYB206, ABP 234
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/003
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
OPDIVO 10 mg/mL concentrate for solution for infusion.
PRD2941372 · Product
- Active substance
- Nivolumab
- Substance synonyms
- BMS936558, ABP 206
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 480 mg milligram(s)
- Max total dose
- 480 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF01 — -
- Marketing authorisation
- EU/1/15/1014/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tecentriq 1 200 mg concentrate for solution for infusion
PRD5434939 · Product
- Active substance
- Atezolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 1680 mg milligram(s)
- Max total dose
- 1680 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF05 — -
- Marketing authorisation
- EU/1/17/1220/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IMFINZI 50 mg/mL concentrate for solution for infusion
PRD6651398 · Product
- Active substance
- Durvalumab
- Substance synonyms
- MEDI4736
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF03 — -
- Marketing authorisation
- EU/1/18/1322/001
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Semmelweis University
- Sponsor organisation
- Semmelweis University
- Address
- Üllő út 26.
- City
- Budapest
- Postcode
- 1085
- Country
- Hungary
Scientific contact point
- Organisation
- Semmelweis University
- Contact name
- Semmelweis University Heart and Vascular Centre
Public contact point
- Organisation
- Semmelweis University
- Contact name
- Semmelweis University Heart and Vascular Centre
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ongoing, recruiting | 1,000 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Semmelweis University
Városmajor Carviovascular Center, Ulloi Ut 26, 1085, Budapest VIII
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 |
|---|---|---|---|---|---|
| Hungary | 2026-01-20 | 2026-02-18 |
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) | Kutatasi terv | 3 |
| Protocol (for publication) | Protokoll alairasi oldal | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | Informed consent form | 3 |
| Subject information and informed consent form (for publication) | Tajekoztatason alapulo beleegyezo nyilatkozat | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | Imfinzi SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Keytruda SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Opdivo SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Tecentriq SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Yervoy SmPC | 1 |
| Synopsis of the protocol (for publication) | Clinical trial protocol | 3 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-26 | Hungary | Acceptable 2025-12-19
|
2026-01-14 |