DANUBE (DT vs C - all population), 2020 NCT02516241
durvalumab plus tremelimumab (n=342) vs. gemcitabine plus platin (n=344)
randomized controlled trial
durvalumab plus tremelimumab
durvalumab monotherapy (at a fixed dose of 1500 mg, administered intravenously every 4 weeks) Dose reductions were not permitted for durvalumab or durvalumab plus tremelimumab.
platine based chemotherpy
IV infusions of cisplatin at a dose of 70 mg/m2 on day 2 of each 28-day cycle plus gemcitabine at 1000 mg/m2 on days 1, 8, and 15 of each 28-day cycle, for up to six cycles; OR IV infusions of cisplatin at 70 mg/m2 on day 1 of each 21-day cycle plus gemcitabine at 1000–1250 mg/m2 on days 1 and 8 of each 21-day cycle, for up to six cycles
3 arms : durvalumab alone or with tremelimumab vs SOC; crossover from the chemotherapy group to either the durvalumab or durvalumab plus tremelimumab groups was not allowed
mUC - L1 - all population
Patients who had received adjuvant or neoadjuvant treatment for locally advanced disease and had progressed within 6 months of their last therapy or surgery were also excluded
open label
243 academic research centres, hospitals, and oncology clinics in 23 countries
P3/ two sided and two interim analysis. Splitting alpha between coprimary endpoint and recycling with hierachical testing procedure for OS ITT (D) and PDL1 high (DT)
This study did not meet either of its coprimary endpoints.
DANUBE (DT vs C - PDL1>25%), 2020 NCT02516241
durvalumab plus tremelimumab (n=205) vs. gemcitabine plus platin (n=207)
randomized controlled trial
durvalumab plus tremelimumab
durvalumab monotherapy (at a fixed dose of 1500 mg, administered intravenously every 4 weeks) Dose reductions were not permitted for durvalumab or durvalumab plus tremelimumab.
platine based chemotherpy (SOC)
IV infusions of cisplatin at a dose of 70 mg/m2 on day 2 of each 28-day cycle plus gemcitabine at 1000 mg/m2 on days 1, 8, and 15 of each 28-day cycle, for up to six cycles; OR IV infusions of cisplatin at 70 mg/m2 on day 1 of each 21-day cycle plus gemcitabine at 1000–1250 mg/m2 on days 1 and 8 of each 21-day cycle, for up to six cycles
3 arms : durvalumab alone or with tremelimumab vs SOC; crossover from the chemotherapy group to either the durvalumab or durvalumab plus tremelimumab groups was not allowed
mUC - L1 - PDL1 positive
Patients who had received adjuvant or neoadjuvant treatment for locally advanced disease and had progressed within 6 months of their last therapy or surgery were also excluded
open label
243 academic research centres, hospitals, and oncology clinics in 23 countries
P3/ two sided and two interim analysis. Splitting alpha between coprimary endpoint and recycling with hierachical testing procedure for OS ITT (D) and PDL1 high (DT)
This study did not meet either of its coprimary endpoints.