Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-19-032
Prinicipal Investigator
Kesterson, Joshua
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
GOG-3018 / VB-111-701
Title
The OVAL Study: A Randomized, Controlled, Double-Arm, Double-Blind, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined with Paclitaxel vs. Paclitaxel Combined with Placebo for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer
Objective
To evaluate the efficacy of the combination of intravenous administration of VB-111 and paclitaxel compared to placebo and paclitaxel in patients with platinum resistant ovarian cancer as measured by Overall Survival (OS).

Secondary
Progression Free Survival (PFS) by RECIST 1.1
Combined CA-125 (GCIG) and RECIST 1.1 objective response rate
Objective response rate (ORR) by RECIST 1.1
CA-125 objective response rate (GCIG)



Applicable Disease Sites
Ovary
Status
Open
Participating Institutions
Hershey Medical Center