A Phase II Study of Nivolumab plus Ipilimumab Immunotherapy in Patients with Aggressive Pituitary Tumors

Full Title

A Phase II Trial of Nivolumab plus Ipilimumab in Patients with Aggressive Pituitary Tumors

Purpose

Surgery and radiation therapy are standard treatments for tumors of the pituitary gland. Sometimes the tumors continue to grow despite these therapies. In this study, researchers are assessing the safety and effectiveness of two immunotherapy drugs, nivolumab and ipilimumab, when used together in patients with pituitary tumors that grow despite surgery and radiation therapy.

Nivolumab and ipilimumab boost the body’s natural defenses against cancer. Nivolumab blocks a protein called PD-1, which can act as a brake on the immune system. Blocking PD-1 “releases the brakes” so the immune system can recognize tumor cells and kill them. Ipilimumab acts against a protein called CTLA-4. Blocking CTLA-4 triggers an immune reaction that helps destroy tumor cells.

Nivolumab and ipilimumab are currently used together to treat advanced melanoma and other cancers; their use in this study is considered investigational. Both drugs are 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 a pituitary tumor that continues to grow despite prior treatment that included surgery and radiation therapy. Patients with inoperable pituitary adenomas may also be able to participate.
  • For patients who previously received treatment with temozolomide, at least 4 weeks must pass between the completion of this therapy and entry into the study.
  • Patients who previously received ipilimumab may not participate.
  • 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. Andrew L. Lin at 212-639-8392.

Protocol

19-216

Phase

II

Investigator

Diseases