174
Participants
Start Date
June 30, 2016
Primary Completion Date
March 31, 2018
Study Completion Date
March 31, 2018
MEDI4736 (Anti PD-L1)
"MEDI4736 1.5g total i.v. every 4 weeks~As monotherapy for the first two weeks (0.75g absolute) (part 1) followed by:~MEDI4736 in combination with nab-paclitaxel 125 mg/m² every week for 12 weeks (part 2) followed by~MEDI4736 in combination with epirubicin 90mg/m² plus cyclophosphamide 600 mg/m² every 2 weeks for 4 cycles (part 3)."
Placebo
"Placebo i.v. every 4 weeks~As monotherapy for the first two weeks (0.75g absolute) (part 1) followed by:~Placebo in combination with nab-paclitaxel 125 mg/m² every week for 12 weeks (part 2) followed by~MEDI4736/Placebo in combination with epirubicin 90mg/m² plus cyclophosphamide 600 mg/m² every 2 weeks for 4 cycles (part 3)."
nab-Paclitaxel
nab-Paclitaxel 125 mg/m² weekly for 12 weeks
Epirubicin
Epirubicin 90 mg/m² 2-weekly for 8 weeks
Cyclophosphamide
Cyclophosphamide 600 mg/m² 2-weekly for 8 weeks
Centrum für Hämatologie und Onkologie am Bethanien-Krankenhaus, Frankfurt am Main
Collaborators (2)
AstraZeneca
INDUSTRY
Celgene
INDUSTRY
GBG Forschungs GmbH
OTHER