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

This phase Ib trial tests the safety, side effects, and best dose of STI-3031 given directly into the into the lymph nodes or the lymph vessels (intra-lymphatic) using the Sofusa DoseConnect device in treating patients with melanoma that has spread through a lymph vessel and begins to grow more than 2 centimeters away from the primary tumor but before it reaches the nearest lymph node (in-transit). Immunotherapy with monoclonal antibodies, such as STI-3031, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

PRIMARY OBJECTIVE: I. To determine the feasibility, safety, and maximum tolerated dose (MTD) of anti-PD-L1 monoclonal antibody IMC-001 (STI-3031) that can be administered through the DoseConnect device in patients with metastatic melanoma demonstrating in-transit and/or regional lymph node metastases. SECONDARY OBJECTIVE: I. To assess clinical benefit rates to STI-3031 administered via DoseConnect device in patients with melanoma in-transit and/or reginal lymph node metastases. CORRELATIVE OBJECTIVES: I. To assess lymphatic drainage of the affected extremity via intralymphatic indocyanine green (ICG) prior to first treatment cycle and prior to last treatment cycle. II. To assess for changes in antitumor immunity as a result of therapy. OUTLINE: Patients receive STI-3031 intra-lymphatically via the DoseConnect device over 1-8 hours once weekly (QW) on days 1, 8, 15, 22, 29, and 36 of cycle 1, and once every 2 weeks (Q2W) on days 1, 15, and 29 of cycle 2. Treatment repeats every 42 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) at the end of cycle 2 receive 1-2 additional cycles in the absence of disease progression or unacceptable toxicity. Patients with partial response (PR) or stable disease (SD) at the end of cycle 2 continue treatment for a total of 9 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 2-4 weeks, 90 days and every 3 months for up to 2 years after study enrollment.