17
Participants
Start Date
December 22, 2020
Primary Completion Date
March 26, 2024
Study Completion Date
June 15, 2028
Tavo
Tavo will be injected on Days 1 and 8 every 4 weeks at a dose volume of ¼ of the calculated lesion volume with a minimum dose volume per lesion of 0.1 mL for lesions of volume \<0.4 cm3
Nivolumab
Nivolumab will be administered 480 mg every 4 weeks over 30 minute infusions
OncoSec Medical Electroporation Therapy System
"The OMS (OncoSec Medical Electroporation Therapy System), a medical EP device system, consists of 3 components: 1. an Electroporation Generator that generates electric pulses, 2. a sterile Applicator Tip containing needle array, and 3. an Applicator Handle that connects to the Electroporation Generator at the proximal end and connects to the Applicator Tip at the distal end.~Upon user activation of the attached Foot Switch, the OMS Electroporation Generator delivers controlled electrical pulses in a square wave pulse pattern yielding optimal transmembrane potential for electroporation to occur. EP pulses occur between 6 hexagonal opposing needle electrodes. After the first pulse, the polarity between the opposing needle electrode pairs is reversed and the needle pair is pulsed again. After the initial paired pulse, the pulse delivery is rotated clockwise to the next opposing needle pairs until a total of 6 pulses are delivered to complete the EP sequence."
Moffitt Cancer Center, Tampa
OncoSec Medical Incorporated
INDUSTRY
H. Lee Moffitt Cancer Center and Research Institute
OTHER