non small cell lung cancer (NSCLC), renal cell carcinoma, small cell lung cancer (SCLC), tumors of the head and neck region, bladder carcinoma, malignant melanoma
Conditions
Brief summary
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.
Detailed description
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
Interventions
DRUGYERVOY 5 mg/ml concentrate for solution for infusion
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGTecentriq 1 200 mg concentrate for solution for infusion
Sponsors
Semmelweis University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Hungary
Outcome results
None listed