Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

December 22, 2020

Primary Completion Date

March 26, 2024

Study Completion Date

June 15, 2028

Conditions
Melanoma
Interventions
DRUG

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

DRUG

Nivolumab

Nivolumab will be administered 480 mg every 4 weeks over 30 minute infusions

DEVICE

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."

Trial Locations (1)

33612

Moffitt Cancer Center, Tampa

All Listed Sponsors
collaborator

OncoSec Medical Incorporated

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER