Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Phase II, Double-Blind, Randomized, Single Center Trial Of Ovapuldencel-T (Autologous Dendritic Cells Loaded With Irradiated Autologous Tumor Cells In GM-CSF) vs. Autologous Peripheral Blood Mononucle
Brief Summary:
This is a double-blind study in which approximately 99 study patients will be randomized in a 2:1 ratio to receive either ovapuldencel-T (autologous dendritic cells loaded with irradiated autologous tumor cells in GM-CSF) or MC (autologous PBMC in GM-CSF). Patients eligible for treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis, (4) are scheduled for primary adjuvant chemotherapy, and (5) have an ECOG performance grade of 0 or 1.
The primary endpoint of this trial is death from any cause with the metric of overall survival (OS) from the date of randomization. Progression-free survival (PFS) will be a secondary endpoint and will be calculated as the time from the date of randomization for treatment until subjective tumor progression or death. Progression will be subjectively defined by the treating physician, and is expected to be based on tumor marker levels (e.g. CA-125) and/or imaging. Secondarily, we will also define PFS and OS from the date of debulking surgery.
Patients will be stratified into (1) platinum-resistant, based on progression during adjuvant chemotherapy or detectable disease at the conclusion of adjuvant therapy or (2) platinum-sensitive, with no evidence of disease (NED) at the conclusion of adjuvant therapy (per elevated blood CA-125 and/or tumor markers and/or detection of disease by physical examination or imaging).
Summary of Stratification and Treatment Plan Platinum Sensitive Platinum Resistant Ovapuldencel-T Arm Ovapuldencel-T + Paclitaxel Ovapuldencel-T+ Secondary Adjuvant therapy MC Arm Mononuclear cells + Paclitaxel Mononuclear cells + Secondary Adjuvant therapy