An Exploratory Study to Evaluate the Mediators of Sensitivity and Resistance to Nivolumab plus Ipilimumab Immunotherapy in Patients with Advanced Non-Small Cell Lung Cancer

Full Title

An Exploratory Study to Evaluate the Mediators of Sensitivity and Resistance to Nivolumab plus Ipilimumab in Patients with Advanced NSCLCs

Purpose

The purpose of this study is to understand why some patients with non-small cell lung cancer (NSCLC) respond to combination immunotherapy with nivolumab plus ipilimumab, while others do not. Nivolumab is approved for treating several types of cancer and nivolumab plus ipilimumab is approved for treating melanoma, but nivolumab plus ipilimumab has not been approved for lung cancers and its use is considered investigational.

Both nivolumab and ipilimumab boost the body's immune system by targeting proteins on white blood cells called PD-1 and CTLA-4. The function of these proteins is to maintain 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 and CTLA-4, enabling them to escape attack by the body's white blood cells. By blocking PD-1 and CTLA-4, nivolumab and ipilimumab allow the immune reaction to continue. The immune reaction may help the body to destroy cancer cells. Nivolumab and ipilimumab are given intravenously (by vein).

Patients will have tumor tissue and blood samples taken before and during nivolumab and ipilimumab therapy. Researchers will examine the tumor and blood samples to see if they can identify factors that indicate which patients will respond to nivolumab plus ipilimumab and which will not.

Eligibility

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

  • Patients must have advanced NSCLC.
  • Patients must have a need for a surgical procedure to remove a portion of their disease before treatment with nivolumab plus ipilimumab begins. Examples include patients with painful metastases who would benefit from surgery to remove them, and those who need a surgical procedure to drain fluid that builds up in the lungs.
  • Patients may have had no more than two other prior regimens of chemotherapy. At least 3 weeks must pass between completion of previous chemotherapy and entry into the study. Those who have not had prior chemotherapy may also be eligible.
  • Patients may NOT have previously been treated with 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 patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Matthew Hellmann at 646-888-4863.

Protocol

14-137

Phase

II

Investigator

Co-Investigators

Locations