A Phase II Study of Pembrolizumab Immunotherapy plus Local Chemotherapy using Isolated Limb Infusion for Patients with Advanced Sarcoma in the Arm or Leg

Full Title

A Phase II Study of Concurrent Systemic Pembrolizumab and Isolated Limb Infusion (ILI) with Melphalan and Dactinomycin for Patients with Locally Advanced or Metastatic Extremity Sarcoma

Purpose

Isolated limb infusion (ILI) is a way to give anticancer drugs directly into an arm or leg to treat a sarcoma. However, despite this treatment, sometimes the cancer still spreads to other parts of the body. In this study, researchers want to see if adding the immunotherapy drug pembrolizumab to ILI treatment with the chemotherapy drugs melphalan and dactinomycin can help prevent the spread of cancer and increase the effectiveness of the ILI treatment in people with advanced sarcoma.

Pembrolizumab works by blocking a molecule called PD-1 that shuts down the immune response. Blocking PD-1 can allow the immune system to detect and attack cancer cells. Pembrolizumab is already approved to treat several cancers; its use in combination with ILI is considered investigational. It is given intravenously (by vein).

Protocol
20-104
Phase
Phase II (phase 2)
Disease Status
Relapsed or Refractory
Investigator
ClinicalTrials.gov ID
NCT04332874