A Phase II Study of Immunotherapy with Nivolumab, with or without Ipilimumab, in Patients with Metastatic or Inoperable Sarcoma

Full Title

Randomized Phase II Study of Nivolumab With or Without Ipilimumab in Patients with Metastatic or Unresectable Sarcoma (Alliance A091401) (CIRB)


The purpose of this study is to determine the safety and effectiveness of giving the drug nivolumab alone or in combination with ipilimumab in patients with metastatic or inoperable sarcoma that persists despite prior treatment.

Nivolumab is a form of immunotherapy. It 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 mechanism by expressing PD-L1, enabling them to escape attack by the body’s white blood cells. Nivolumab blocks PD-1, enhancing the body’s ability to detect and destroy cancer cells.

Ipilimumab is another form of immunotherapy. It is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down at the right time. Ipilimumab is already approved for treating melanoma, and prior studies have shown that combining it with nivolumab can be very effective for shrinking melanoma tumors. Nivolumab is approved for treating several types of cancer. The use of nivolumab and ipilimumab in this study is considered investigational.

Patients in this study will be randomly assigned to receive nivolumab alone or nivolumab plus ipilimumab. Both drugs are 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 metastatic or inoperable bone sarcoma or soft-tissue sarcoma that has continued to grow despite at least one prior regimen of therapy.
  • At least 4 weeks must pass between completion of prior treatment and entry into 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.