Phase II Study of Pembrolizumab and Cabozantinib Combination for Adults With Advanced Sarcomas Including Undifferentiated Pleomorphic Sarcoma, Osteosarcoma, and Ewing Sarcoma

What this Trial Is About

Researchers are evaluating the combination of pembrolizumab and cabozantinib in adults with advanced sarcomas, including undifferentiated pleomorphic sarcoma, osteosarcoma, and Ewing sarcoma. This phase II trial uses three independent groups to study the effects of this drug combination on these distinct sarcoma populations. The goal is to assess how this treatment works in patients with advanced, metastatic, or recurrent disease that has progressed after standard therapy. Participants receive pembrolizumab intravenously every three weeks at a dose of 200 mg, along with daily oral cabozantinib at 40 mg. Treatment cycles last three weeks, and all three sarcoma groups receive the same combination therapy. The study is designed as a single-arm, non-randomized trial, operating independently for each sarcoma type to measure treatment response and safety. During the study, participants will have regular assessments including scans to measure tumor size, blood tests to monitor immune markers, and evaluations of overall health and side effects. Researchers will track outcomes like response to treatment, progression-free survival, overall survival, and safety over months. The main focus is on treatment effectiveness at six months, with ongoing monitoring throughout the treatment period and up to one year for some outcomes. Participation involves multiple visits for treatment and testing, with careful safety monitoring.

Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas