A Phase I Study of Stereotactic Radiosurgery with Nivolumab Immunotherapy in Patients with Recurrent or Advanced Chordoma

Full Title

Phase I Safety study of Stereotactic Radiosurgery with Concurrent and Adjuvant PD-1 Antibody Nivolumab in Subjects with Recurrent or Advanced Chordoma.

Purpose

Chordomas are rare tumors of the skull base and spine that are typically surgically removed, but have a high chance of coming back. They can be very resistant to conventional radiation therapy and chemotherapy. In this study, researchers are evaluating the use of nivolumab immunotherapy alone and with stereotactic radiosurgery in patients with recurrent or advanced chordoma. Patients will receive nivolumab alone or nivolumab followed by one to five sessions of focused radiation therapy.

Nivolumab boosts the body’s immune system by targeting a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this shut-down mechanism by activating PD-1, enabling them to escape attack by the body’s white blood cells. Nivolumab binds to and inactivates PD-1, enhancing the body’s ability to detect and destroy cancer cells. It is used to treat several types of cancer; its use in this study is considered investigational. Nivolumab 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 recurrent or advanced chordoma.
  • At least 3 weeks must pass since prior chemotherapy and 6 months since previous radiation therapy and entry into the study.
  • Patients may not have previously received immunotherapy that inhibits PD1, PD-L1, or PD-L2.
  • 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 15 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Yoshiya (Josh) Yamada at 212-639-2950.

Protocol

18-020

Phase

I

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators