Rak nerki: badanie fazy III leku MK-6482 i zanzalintinib

Kryteria wyłączenia kto nie może wziąć udziału (14)

1. The main exclusion criteria include but are not limited to the following:
2. Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, new-onset angina, pulmonary embolism, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
3. Had deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization
4. Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram
5. Has had major surgery within 8 weeks before randomization or has not adequately recovered from major surgery or has ongoing surgical complications
6. Has current pneumonitis/interstitial lung disease
7. Has symptomatic pleural effusion (for example cough, dyspnea, pleuritic chest pain), ascites, or pericardial fluid requiring drainage within 4 weeks prior to randomization
8. Has a gastrointestinal disorder including those associated with a high risk of perforation or fistula formation
9. Has a serious active nonhealing wound/ulcer/bone fracture
10. Has a requirement for hemodialysis or peritoneal dialysis
11. Has history of human immunodeficiency virus infection
12. Has hepatitis B or hepatitis C virus
13. Has pharmacologically uncompensated, symptomatic hypothyroidism
14. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention