Phase I Study of Pazopanib Combined With Trabectedin, Ipilimumab, and Nivolumab in Children and Young Adults With Recurrent Soft Tissue Sarcomas

What this Trial Is About

Researchers are studying the safety and proper dosing of adding pazopanib to a chemotherapy combination of trabectedin, ipilimumab, and nivolumab in children and young adults with recurrent soft tissue sarcomas. This phase I trial aims to find the recommended dose and monitor how well patients tolerate this combination. The study also observes tumor response and progression to understand how the treatment affects the disease. Participants receive ipilimumab through intravenous infusions every 9 weeks, trabectedin intravenously every 3 weeks over 3 hours, and nivolumab intravenously every 3 weeks. Pazopanib is taken by mouth daily at escalating doses calculated based on body surface area for pediatric patients, with dose levels adjusted weekly. The study includes a pre-phase where trabectedin and pazopanib are given before starting ipilimumab and nivolumab. During the trial, patients undergo laboratory tests and imaging before starting treatment and throughout the study to monitor safety and tumor status. Researchers assess adverse events and evaluate outcomes like best overall response, duration of response, and progression-free survival. The study tracks participants from treatment initiation through about one year to gather safety data and treatment effects.

A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young Adult Patients With Recurrent Soft Tissue Sarcomas