Phase III Study of TRK-950 Alone or with Nivolumab for Advanced Solid Tumors and Melanoma

What this Trial Is About

Researchers are evaluating TRK-950 in patients with advanced solid tumors, including melanoma, who have limited or no standard treatment options. This open-label phase III study aims to assess the safety, tolerability, pharmacokinetics, and immune response to TRK-950 alone or in combination with Nivolumab. The study includes patients who have advanced or metastatic tumors refractory or intolerant to existing therapies or those eligible for Nivolumab treatment. The study is divided into three parts. Part 1 involves two dose levels of TRK-950 given intravenously weekly on days 1, 8, 15, and 22 of a 28-day cycle. Part 2 evaluates TRK-950 combined with Nivolumab, where Nivolumab is administered intravenously at 240 mg every two weeks on days 1 and 15, and TRK-950 is given intravenously weekly or bi-weekly depending on the cohort. Part 3 focuses on patients with advanced unresectable or metastatic melanoma who previously received chemotherapy with dacarbazine these patients receive TRK-950 intravenously weekly on days 1, 8, 15, and 22 of a 28-day cycle. Participants will undergo safety monitoring including assessments of dose-limiting toxicities, adverse events, and immune reactions over approximately one year. Researchers will also measure drug levels, survival outcomes, tumor responses, and disease progression. Treatment is given in cycles of 28 days, and the study tracks participants throughout treatment and follow-up until study completion or as long as safety and efficacy data are collected.

A Study of TRK-950 in Patients With Advanced Solid Tumors