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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
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
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, Florida, United States
Pathologic Complete Response
For each subject, the study intervention consists of 3 phases: (1) Neoadjuvant Phase; (2) Surgery Phase; (3) Adjuvant Phase. Completion of all 3 phases is required for primary completion of the study. The study protocol requires that all subjects will be followed for 4 weeks after last dose of nivolumab at End of Study (EOS) visit. That is 4 weeks after the conclusion of the adjuvant phase. For the purpose of reporting the primary outcome measure, Pathologic Complete Response will be estimated based on the proportion of participants who have completed the study phases and were found to have 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. This will be followed by the adjuvant phase. Therefore, the proportion of participants who continue in Pathologic Complete Response following completion of the 3 study phases would be reported.
Time frame: At least four weeks after the last dose of nivolumab at End of Study (EOS) visit
Objective Response Rate
Preoperative ORR assessed by Investigator based on RECIST v1.1 at the conclusion of the Neoadjuvant phase.
Time frame: Conclusion of the neoadjuvant phase.
Relapse Free Survival
RFS assessed by Investigator based on RECIST v1.1 at least four weeks after the last dose of nivolumab at End of Study (EOS) visit.
Time frame: At least four weeks after the last dose of nivolumab at End of Study (EOS) visit
Overall Survival
Overall survival at 1 year after start of therapy.
Time frame: At 1 year after start of therapy
Risk of Surgical Delay
Definitive surgery will be planned at about 12 weeks. Participants will be monitored for surgical delay (either due to toxicity and/or tumor progression). Defined as the number of participants who had Surgery delayed due to progression.
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Time frame: Up to 16 weeks after start or therapy