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

Inclusion Criteria

• •Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent
• •Histologic diagnosis of melanoma
• •Must be considered surgically operable and may present as any of the following groups:
• •1. Primary melanoma with clinically apparent regional lymph node metastases, confirmed by pathological diagnosis.
• •2. Clinically detected recurrence of melanoma at regional lymph node basin(s), confirmed by pathological diagnosis.
• •3. Clinically or histologically detected primary melanoma involving multiple regional nodal groups, confirmed by pathological diagnosis.
• •4. Clinically detected single site of nodal metastatic melanoma arising from an unknown primary, confirmed by pathological diagnosis.
• •5. Participants with in transit or satellite metastases with or without lymph node involvement are allowed if they are considered surgically resectable at Screening by the treating surgical oncologist.
• •6. Participants with distant cutaneous/subcutaneous, soft tissue or nodal metastases with or without regional lymph node involvement are allowed if they are considered potentially surgically resectable and can be biopsied at Screening by the treating surgical oncologist. Elevated LDH is not an exclusion.
• •Participants are eligible for this study either at presentation for primary melanoma with concurrent regional nodal and/or in-transit or distant metastasis, or at the time of clinically detected nodal, in transit, or distant recurrence
• •Participants must be evaluated by standard-of-care full body imaging studies including positron emission tomography - computed tomography (PET-CT ;preferred; including diagnostic CT component if possible) or CT (if PET-CT cannot be done) as well as magnetic resonance imaging (MRI) of the brain (or CT if MRI cannot be done) as part of the initial clinical work-up at Screening (no more than 4 weeks prior to Cycle 1, Day 1).
• •Have measurable disease based on RECIST v1.1, with at least one anatomically distinct lesion. Lesion or lesions must meet all the following baseline criteria:
• •1. Accessible for electroporation
• •2. Must be measured in at least one dimension (longest diameter in the plane of measurement is to be recorded)
• •3. Greater than 3 mm
• •Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• •Male Participants: Male subjects of childbearing potential must be surgically sterile, or must agree to use adequate method of contraception during the study and at least 5 months following the last day of study drug administration. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
• •Female participants: Women of childbearing potential must have negative serum or urine pregnancy test within 72 hours prior to receiving the first study drug administration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. For women of childbearing potential, must be willing to use an adequate method of contraception from 30 days prior to the first study drug administration and 5 months following last day study drug administration (either tavo or nivolumab); acceptable methods include hormonal contraception (oral contraceptives - as long as on stable dose, patch, implant, and injection), intrauterine devices, or double barrier methods (e.g. vaginal diaphragm/vaginal sponge plus condom, or condom plus spermicidal jelly), sexual abstinence or a vasectomized partner. Women may be surgically sterile or at least 1-year post-last menstrual period. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
• •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol