Screening (within 14 days prior C1D1) | During treatment (1 cycle = 28 days) | End of treatment (within 4 weeks after last dose) | Follow-up after the end of treatment | Overall survival after disease progression | ||
---|---|---|---|---|---|---|
Every cycle | ||||||
D1 | D15 | |||||
Informed Consent should be done before any study procedures | ||||||
Informed consent | ✔ | |||||
Inclusion/Exclusion Criteria | ✔ | |||||
Demographics - Medical/surgical history and prior treatment for urothelial carcinoma | ✔ | |||||
Prior and Concomitant Medication Review | ✔ | ✔ | ✔ | ✔ | ||
Trial treatment administration | ✔ | ✔ | ||||
Complete physical, weight, height (only at baseline), ECOG, vital signs | ✔a | ✔ | ✔ | ✔ | ✔i | |
Adverse Events (AEs) collection | ✔ | ✔ | ✔ | ✔i | ||
CBC, platelets, hemoglobin | ✔a | ✔ | ✔ | ✔ | ||
Blood biochemistry | ✔a,b | ✔b (cycle 1: within 7 days prior C1D1) | ✔g | ✔b | ||
Coagulation | ✔a,c | ✔(if clinically indicated) | ||||
Thyroid-function testing: thyroid-stimulating hormone [TSH], free T4 | ✔a | ✔h | ✔ | |||
HIV, HBV and HCV serology | ✔a,d | |||||
Serum or urine pregnancy test (if applicable) | ✔a | ✔ | ||||
Urinalysis | ✔a,e | ✔(if clinically indicatede | ✔(if clinically indicated)e | |||
ECG | ✔(within 28 days prior C1D1) | ✔(if clinically indicated) | ||||
Tumor imagingf | ✔(within 28 days prior C1D1) | ✔(Every 8 weeks) | ✔ | ✔j | ||
Quality of life (QLQ-C30 and EQ-5D) | ✔a | ✔(Every 8 weeks) | ✔ | |||
Patient diary | ✔ | |||||
Survival status | ✔k | |||||
BLOOD and TUMOR BANKING for further ancillary biological studies for patients having given their specific informed consent | ||||||
Blood samples | ✔l | |||||
Fixed primitive tumor sample (or 20 slides) | ✔ |