Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04526730|
Recruitment Status : Recruiting
First Posted : August 26, 2020
Last Update Posted : July 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Tavo Drug: Nivolumab Device: OncoSec Medical Electroporation Therapy System||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Immunotherapy With Intratumoral Tavokinogene Telseplasmid (Tavo) Plus Electroporation in Combination With Intravenous Nivolumab in Patients With Operable Locally- Regionally Advanced Melanoma|
|Actual Study Start Date :||December 22, 2020|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2022|
Experimental: Neoadjuvant Treatment
Neoadjuvant Phase: (3 x 4-week cycles, total 12 weeks): At every cycle, intratumoral tavo-EP will be administered (on Days 1 and 8) concurrently with 480 mg nivolumab IV infusion on Day 8 of each cycle (tavo-EP will be administered prior to nivolumab infusion).
Definitive Surgery Phase: Surgery may be scheduled about 2-4 weeks after the last dose of nivolumab following radiologic and clinical assessment at that point. Pathologic response will be determined by institutional pathologist.
Adjuvant Phase: Adjuvant therapy with nivolumab monotherapy will begin approximately 2-4 weeks following definitive surgery; recovery from surgery is required (Day 1 of Cycle 4 will be determined by the treating investigator once the subject is cleared to initiate systemic therapy). Nivolumab (480 mg IV infusion on Day 1 of each 4-week cycle) will be administered for up to 9 cycles during the Adjuvant phase.
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 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.
Other Name: Electroporation
- Pathological Complete Response [ Time Frame: Up to 16 weeks after start of therapy ]Pathological Complete Response will be will be estimated based on the proportion of participants with no viable tumor on histologic assessment at definitive surgery after the 12 week Neoadjuvant phase. Surgery will then be scheduled 2-4 weeks after neoadjuvant phase.
- Objective Response Rate [ Time Frame: 12 weeks after start of therapy ]ORR assessed by Investigator based on RECIST v1.1 at 12 weeks during the Neoadjuvant phase
- Relapse Free Survival [ Time Frame: 12 weeks after start of therapy ]RSF assessed by Investigator based on RECIST v1.1 at 12 weeks during the Neoadjuvant phase
- Overall Survival [ Time Frame: Up to 5 years after start of therapy ]Overall survival at 5 years after start of therapy
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 5 years after start of therapy ]To determine the safety and tolerability of combined treatment as neoadjuvant therapy will be based on the frequency of AEs
- Risk of Surgical Delay [ Time Frame: Up to 16 weeks after start or therapy ]Definitive surgery will be planned at about 12 weeks. Participants will be monitored for surgical delay (either due to toxicity and/or tumor progression).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04526730
|Contact: Deanryan Deaquino||813-745-3998||Deanryan.Deaquino@moffitt.org|
|United States, Florida|
|Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Deanryan De Aquino 813-745-3998 Deanryan.Deaquino@moffitt.org|
|Principal Investigator: Ahmad Tarhini, MD, PhD|
|Sub-Investigator: Vernon Sondak, MD|
|Sub-Investigator: Jonathan Zager, MD|
|Sub-Investigator: Amod Sarnaik, MD|
|Sub-Investigator: Nikhil Khushalani, MD|
|Sub-Investigator: Zeynep Eroglu, MD|
|Sub-Investigator: Joseph Markowitz, MD, PhD|
|Sub-Investigator: Andrew Brohl, MD|
|Sub-Investigator: Ann Chen, PhD|
|Principal Investigator:||Ahmad Tarhini, MD, PhD||Moffitt Cancer Center|