Intra-Lymphatic STI-3031 Using the Sofusa DoseConnect Device for Treatment of In-Transit Melanoma, The Sofusa-2 Study

Inclusion Criteria: * Age \>= 18 years * Disease characteristics: * Newly diagnosed, recurrent, or previously treated in-transit metastatic melanoma (ITM) confined to a single limb with or without regional lymph node involvement * For patients with ITM, one of the following must be true: * A visible superficial ITM, non-nodal lesion with longest diameter \>= 1.0 cm in diameter as assessed using a ruler (e.g., skin nodules) NOTE: Documentation by color photography, including a ruler is required OR * A malignant regional lymph node with short axis \> 1.0 cm as assessed by computed tomography (CT) scan (CT scan slice thickness recommended to be no greater than 5 mm) OR * A non-visible, non-nodal soft tissue mass of the involved extremity with longest diameter \>= 1.0 cm as measured with CT scan, CT component of a positron emission tomography (PET)/CT, or magnetic resonance imaging (MRI) * Newly diagnosed, recurrent or previously treated metastatic melanoma of the lymph nodes in lymphatic beds accessible to limb-lymphatic infusion (Example: lower limb lymphatic accessible femoral, inguinal pelvic and/or retroperitoneal lymph node metastases; upper limb: axillary, infraclavicular and/or subclavian lymph node metastases) * For patients with lymph node metastases only (non ITM) the following must be true: * At least one tumor involved lymph nodes must be \>= 15 mm as assessed by CT, PET or MRI (target lesion by Response Evaluation Criteria i…