Clinical trial • Phase IV • Oncology

Durvalumab for Non-small cell lung cancer | Renal cell carcinoma | Small cell lung cancer | Head and neck cancer | Bladder cancer | Malignant melanoma

Overview

Trial Therapeutic Area: Oncology
Trial Disease: Non-small cell lung cancer | Renal cell carcinoma | Small cell lung cancer | Head and neck cancer | Bladder cancer | Malignant melanoma
Trial Stage: Phase IV
Drug Modality: Monoclonal antibody

Key dates

Initial CTIS Submission Date: 26-10-2025
First CTIS Authorization Date: 14-01-2026

Trial design

Phase IV trial across 1 site in Hungary.

Target Sample Size: 1000

Eligibility

Recruits 1000 Vulnerable populations not selected. Consent must be signed by the patient ("Signing of the patient information sheet and consent form by the patient"). Age under 18 is excluded and illiteracy is an exclusion criterion. No assent process or other vulnerable-population consent procedures are described..

Pregnancy Exclusion: Pregnancy and breastfeeding
Vulnerable Population: Vulnerable populations not selected. Consent must be signed by the patient ("Signing of the patient information sheet and consent form by the patient"). Age under 18 is excluded and illiteracy is an exclusion criterion. No assent process or other vulnerable-population consent procedures are described.

Inclusion criteria

{"criterion_text":"- Patients presented to the oncology teams of Semmelweis University and clinics in the country wishing to join the research\n- Planned immune checkpoint inhibitor therapy\n- At least 18 years of age\n- Signing of the patient information sheet and consent form by the patient\n- Accessible medical history"}

Exclusion criteria

{"criterion_text":"- Lack of informed consent form\n- Age under 18\n- Illiteracy\n- Pregnancy and breastfeeding"}

Endpoints

Primary endpoints

{"endpoint_text":"- The primary endpoint is defined as a 5-point MACE composite endpoint, which includes the following events: •\tcardiovascular death, •\tnon-fatal myocardial infarction, •\tnon-fatal stroke, •\tunstable angina requiring hospitalization and/or urgent coronary revascularization, •\thospitalization due to heart failure.","definition_or_measurement_approach":"Defined as a 5-point MACE composite endpoint including 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

{"endpoint_text":"- 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","definition_or_measurement_approach":"The listed cardiovascular 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 not included in the primary MACE composite."}

Recruitment

Planned Sample Size: 1000
Recruitment Window Months: 60
Consent Approach: Informed consent must be signed by the patient ("Signing of the patient information sheet and consent form by the patient"). Age under 18 is excluded. Informed consent form and subject information documents are listed in the trial documents, but languages available are not specified. No assent process is described.

Methods

Recruitment of patients presented to the oncology teams of Semmelweis University and oncology clinics across the country (Hungary) who wish to join the research; target audience: patients planned to receive immune checkpoint inhibitor therapy.

Geography

Total Number Of Sites: 1
Total Number Of Participants: 1000

Hungary

Earliest CTIS Part Ii Submission Date: 12-12-2025
Latest Decision Or Authorization Date: 14-01-2026
Processing Time Days: 33
Number Of Sites: 1
Number Of Participants: 1000

Sites

Site Name: Semmelweis University
Department Name: Városmajor Carviovascular Center
Contact Person Name: Zsófia Dóra Drobni
Contact Person Email: drobni.zsofia@semmelweis.hu

Sponsor

Primary sponsor

Full Name: Semmelweis University
Organisation Type: Educational Institution
Country Of Registered Address: Hungary

Investigational products

Investigational Product Name: IMFINZI 50 mg/mL concentrate for solution for infusion
Active Substance: Durvalumab
Modality: Monoclonal antibody
Routes Of Administration: INFUSION
Route: INFUSION
Authorisation Status: Marketing authorisation number EU/1/18/1322/001
Maximum Dose: 1500 mg

Investigational Product Name: YERVOY 5 mg/ml concentrate for solution for infusion
Active Substance: Ipilimumab
Modality: Monoclonal antibody
Routes Of Administration: INFUSION
Route: INFUSION
Authorisation Status: Marketing authorisation number EU/1/11/698/001
Maximum Dose: 1 mg/kg

Investigational Product Name: OPDIVO 10 mg/mL concentrate for solution for infusion.
Active Substance: Nivolumab
Modality: Monoclonal antibody
Routes Of Administration: INFUSION
Route: INFUSION
Authorisation Status: Marketing authorisation number EU/1/15/1014/001
Maximum Dose: 480 mg

Investigational Product Name: Tecentriq 1 200 mg concentrate for solution for infusion
Active Substance: Atezolizumab
Modality: Monoclonal antibody
Routes Of Administration: INFUSION
Route: INFUSION
Authorisation Status: Marketing authorisation number EU/1/17/1220/001
Maximum Dose: 1680 mg

Investigational Product Name: KEYTRUDA 25 mg/mL concentrate for solution for infusion.
Active Substance: Pembrolizumab
Modality: Monoclonal antibody
Routes Of Administration: INFUSION
Route: INFUSION
Authorisation Status: Marketing authorisation number EU/1/15/1024/003
Maximum Dose: 200 mg

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