Phase 12 Study Evaluating Lurbinectedin with Ipilimumab and Nivolumab for Advanced Soft Tissue Sarcoma

What this Trial Is About

Researchers are studying advanced soft tissue sarcoma in an open-label phase 12 trial that tests increasing doses of Lurbinectedin combined with fixed doses of Ipilimumab and Nivolumab given intravenously. The study aims to find the highest safely tolerated dose and evaluate safety and potential effectiveness in participants with this condition. The trial includes participants with locally advanced or metastatic soft tissue sarcoma, both previously treated and untreated depending on the study phase. The study starts with a dose escalation phase using a cohort of three design, where participants receive escalating doses of Lurbinectedin every three weeks, alongside fixed doses of Ipilimumab every 12 weeks and Nivolumab every two weeks. Dose escalation proceeds after safety evaluation for six weeks to determine the maximum tolerated dose or maximum administered dose. In the phase 2 part, additional participants receive treatment at the established dose levels to assess safety and potential effects over time. Participants will be monitored closely during treatment, which can continue up to one year or until disease progression or unacceptable side effects occur. Researchers will assess safety, response rates, progression-free survival, and overall survival over months to years. Evaluations include clinical and laboratory tests, with special attention to dose-limiting toxicities during the initial six weeks. The trial may include up to 18 doses of Lurbinectedin, 26 of Nivolumab, and 5 of Ipilimumab, with ongoing follow-up to collect data on treatment impact.

LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma