PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma

Exclusion Criteria

• •1. Presence or history of visceral melanoma metastasis
• •2. Presence of active nodal metastases (e.g., radiologic or clinical evidence of current nodal disease)
• •3. Presence of more than 50 melanoma lesions
• •4. Radiation therapy to any Study Lesion within 6 weeks of initial study treatment.
• •5. Chemotherapy or other systemic cancer therapy within 4 weeks of initial study treatment (6 weeks for nitrosoureas or mitomycin), or regional chemotherapy (limb infusion or perfusion) within 12 weeks of initial study treatment
• •6. Immunotherapy for cancer within 4 weeks of initial study treatment
• •7. Local treatment (e.g., surgery, cryotherapy, laser ablation) to any Study Lesion within 4 weeks of initial study treatment
• •8. Anti-tumor vaccine therapy within 6 weeks of initial study treatment.
• •9. Investigational agents within 4 weeks of initial study treatment.
• •10. Concurrent or Intercurrent Illness:
• •* Impaired wound healing or other extremity complications due to diabetes mellitus in subjects whose Study Lesions are located in an extremity
• •* Severe peripheral vascular disease in subjects whose Study Lesions are located in an extremity
• •* Significant concurrent or intercurrent illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the Investigator, compromise the subject's safety or compliance or interfere with interpretation of study results.
• •* Uncontrolled thyroid disease or cystic fibrosis
• •* Clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological, endocrine, or central nervous system disorders
• •11. Pregnancy:
• •* Female subjects who are pregnant or lactating
• •* Female subjects who have positive serum pregnancy test taken within 14 days of study treatment
• •* Female subjects of child-bearing potential who are unwilling to use highly effective contraception (e.g., combined (estrogen and progestogen containing) or progestogen-only hormonal contraceptives, intrauterine devices, bilateral tubal ligation, vasectomized partner, sexual abstinence or equivalent measures) for the duration of study treatment
• •12. Contraindication for all comparators:
• •* Subjects with contraindications to all of the designated comparator drugs