Phase 1/2 Study of Motolimod, Doxorubicin, and Durvalumab in Recurrent, Platinum-Resistant Ovarian Cancer
Status:
Completed
Trial end date:
2021-06-10
Target enrollment:
Participant gender:
Summary
This is an ongoing Phase 1/2, open-label, multicenter, non-randomized study of MEDI4736
(durvalumab) in subjects with recurrent, platinum-resistant ovarian cancer who are scheduled
to receive pegylated liposomal doxorubicin (PLD).The primary objective of Phase 1 is to
determine the maximum tolerated dose (MTD) and safety profile, with a secondary objective to
evaluate the clinical efficacy as measured by progression-free survival (PFS) rate at 6
months (PFS-6). The primary objective of Phase 2 is the evaluation of clinical efficacy as
measured by PFS-6. For both phases, secondary objectives include evaluation of clinical
efficacy as measured by overall response rate, PFS, and overall survival (OS), safety and
tolerability, and immunological responses.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborators:
Cancer Research Institute, New York City Celgene MedImmune LLC VentiRx Pharmaceuticals Inc.