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

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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).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced sarcoma in an arm or leg that persists despite prior treatment. This includes myxofibrosarcoma, undifferentiated pleomorphic sarcoma, and alveolar soft part sarcoma.
  • Patients must be eligible for ILI treatment and pembrolizumab.
  • At least 2 weeks must pass between the completion of prior therapy and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Edmund Bartlett at 212-639-2448.

Protocol

20-104

Phase

II

Disease Status

Relapsed or Refractory

Investigator