no treatment
other systemic antitumor therapy was not permitted but palliative local radiotherapy for isolated lesions was acceptable.
all patients received best supportive care ( will be administered as deemed appropriate by the treating physician, and could include treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including palliative radiotherapy), etc. BSC does not include any active anti-tumor therapy, however local radiotherapy of isolated lesions with palliative intent is acceptable.)
mUC - M - PDL1 positive
stage IV disease at initiation of first-line chemotherapy; PD-L1 status was defined as expression in ≥25% of tumor cells or in ≥25% or 100% of tumor-associated immune cells if the percentage of immune cells was >1% or ≤1%, respectively (SP263 assay).
open label
197 sites in 29 countries
P3/ one sided and one interim analysis. Splitting alpha between corpimary endpoint (0.015 OS ITT and 0.01 PDL1>25%) no plan for secondary endpoint
Avelumab Displays Survival Benefit in JAVELIN Bladder 100 Trial : avelumab was found to have met its primary study endpoint of improved overall survival (OS)