durvalumab phase 1/2, trial summary

A randomised clinical trial investigating the effect of durvalumab versus nil in patients with locally-advanced or metastatic urothelial carcinoma of the bladder who had progressed while on or after a platinum-containing chemotherapy, including those who progressed within 12 months of receiving therapy in a neoadjuvant or adjuvant setting

        Z

2nd line



Studied treatment durvalumab at 10 mg/kg body weight administered as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity
Control treatment



Patients patients with locally-advanced or metastatic urothelial carcinoma of the bladder who had progressed while on or after a platinum-containing chemotherapy, including those who progressed within 12 months of receiving therapy in a neoadjuvant or adjuvant setting
Group sizes-9 / -9



Blindness Inclusion period
Follow-up duration Centers
Lost to FU geographical localisation
Primary endpoint Design Single-arm study

phase 1/2



EndpointX1N1X0N0TE95% CI PFS - -9 - -9 no data ORR - -9 - -9 no data OS - -9 - -9 no data CR - -9 - -9 no data0,22,01,0



Registering number (see trial on clinicaltrials.gov)
Code Name Study 1108