A Phase II Study of Nivolumab Immunotherapy to Treat Recurrent or Persistent Uterine Cancer

Full Title

Phase II Trial of Single-Agent Nivolumab in Patients with Microsatellite Unstable/Mismatch Repair Deficient/Hypermutated Uterine Cancer


Nivolumab is an immunotherapy drug that 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. Nivolumab blocks PD-1, enhancing the body’s ability to find and kill cancer cells. It is approved by the FDA to treat several types of cancer; its use in this study is considered investigational.

In this study, researchers are assessing the safety and effectiveness of nivolumab in women with a subtype of uterine cancer that either lacks a protein that fixes DNA (“mismatch repair-deficient”) or uterine cancer that has many genetic mutations found during specialized testing (such as MSK-IMPACT or FoundationOne). Nivolumab is given intravenously (by vein).


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

  • Patients must have endometrial carcinoma, endometrial carcinosarcoma, or uterine sarcoma that came back or continued to grow after previous chemotherapy.
  • Patients’ tumors must have specific features that indicate they would respond to nivolumab. Testing for these features will be done as part of this study.
  • Patients may not have had prior treatment with a PD-1 inhibitor or similar immunotherapy.
  • 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 women age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Claire Friedman at 646-888-4247.