NCT04526730

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

Neoadjuvant Immunotherapy With Intratumoral Tavokinogene Telseplasmid (Tavo) Plus Electroporation in Combination With Intravenous Nivolumab in Patients With Operable Locally- Regionally Advanced Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 open-label, single-arm study of neoadjuvant treatment of intratumoral tavo-EP plus nivolumab IV infusion. Eligible participants will be those with pathological diagnosis of operable locally-regionally advanced melanoma.

Conditions

• Melanoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-12-22
• Primary completion: 2024-03-26
• Completion: 2025-05-22
• First posted: 2020-08-26
• Last updated: 2026-02-20
• Results posted: 2025-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study