A Phase II Study of Pembrolizumab Immunotherapy to Treat Advanced Bone Sarcomas

Full Title

A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients with Advanced Sarcomas

Purpose

Pembrolizumab is an antibody (a type of protein) that binds to cells involved in the immune system. Antibodies are normally made by the body to destroy germs like bacteria and viruses. The antibody used in this study binds to a protein called PD-1 on immune cells, with the goal of stimulating an immune response against cancer cells. In this study, researchers are assessing the safety and effectiveness of pembrolizumab immunotherapy in patients with advanced soft-tissue sarcomas and bone sarcomas that have spread and have not responded to treatment.

Pembrolizumab is approved by the FDA to treat metastatic malignant melanoma and non-small cell lung cancer; its use in this study 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 inoperable or metastatic soft-tissue sarcomas or bone sarcoma that has not responded to at least one but no more than three prior regimens of chemotherapy.
  • Patients must recover from the serious side effects of prior therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Sandra P. D’Angelo at 646-888-4159.

Protocol

15-092

Phase

II

Investigator

Co-Investigators