Phase II Study of Pembrolizumab Combined With Isolated Limb Infusion of Melphalan and Dactinomycin for Advanced or Metastatic Sarcoma in the Arm or Leg

What this Trial Is About

Researchers are evaluating a treatment approach for patients with locally advanced or metastatic sarcoma in the arm or leg. The study aims to determine if giving pembrolizumab together with chemotherapy drugs melphalan and dactinomycin directly to the affected limb using isolated limb infusion ILI is a safe way to delay disease progression. This trial is a Phase II study conducted by Memorial Sloan Kettering Cancer Center focusing on advanced extremity sarcoma. Participants receive pembrolizumab intravenously at a dose of 200 mg on Day 1 and then every three weeks. Pediatric patients receive a weight-based dose up to 200 mg. The isolated limb infusion procedure delivers melphalan and dactinomycin directly into the affected arm or leg via an arterial catheter under anesthesia. The chemotherapy infusion occurs within 18 days after starting pembrolizumab. Pediatric patients receive tailored anti-nausea treatment before the procedure. During the study, participants will be monitored for progression-free survival over six months. Researchers will assess disease status using measurable lesions defined by RECIST 1.1 or clinical evaluation for superficial lesions. Safety and organ function will be regularly checked through blood tests and clinical assessments. The study requires participants to have undergone at least one prior systemic therapy or declined standard options and to have adequate performance status and organ function. The trial continues until disease progression or other endpoints are met, with close follow-up throughout.

A Study of Pembrolizumab Plus Local Chemotherapy Using Isolated Limb Infusion (ILI) for Patients With Sarcoma in the Arm or Leg