53
Participants
Start Date
December 2, 2015
Primary Completion Date
December 11, 2018
Study Completion Date
June 10, 2021
Durvalumab
Durvalumab is administered as an IV infusion over 60 ± 5 minutes.
Pegylated Liposomal Doxorubicin
PLD was administered as an IV infusion in accordance with local prescribing information.
Motolimod
Motolimod was administered as an SC injection. Within 30 minutes prior to each dose of motolimod, subjects were administered 650-1000 mg acetaminophen by mouth to help mitigate potential adverse events (AEs) commonly associated with the administration of motolimod (e.g., fever, myalgia). On days with concurrent motolimod and durvalumab dosing, motolimod administration occurred 30-60 minutes after the end of the durvalumab infusion. After completion of Phase 1, a protocol amendment was implemented to remove motolimod dosing from the study.
Research Facility, Lausanne
Research Facility, New York
Research Facility, Hilliard
Research Facitlity, Phoenix
Research Facility, Providence
Lead Sponsor
Collaborators (2)
MedImmune LLC
INDUSTRY
Celgene
INDUSTRY
Cancer Research Institute, New York City
OTHER
Ludwig Institute for Cancer Research
OTHER