A Phase II Study of Nivolumab in Patients with Previously Treated Advanced Squamous Cell Lung Cancer

Protocol
12-284
Full Title
A Single-Arm Phase 2 Study of Nivolumab in Subjects with Advanced or Metastatic Squamous Cell Non-Small Cell Lung Cancer Who Have Received At Least Two Prior Systemic Regimens
Purpose

The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called nivolumab in patients with stage IIIB or IV squamous cell lung cancer that has continued to grow despite at least two prior regimens of chemotherapy.

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.

Eligibility

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

  • Patients must have stage IIIB or IV squamous cell lung cancer that has continued to grow despite two prior regimens of chemotherapy, including a platinum doublet regimen.
  • At least 2 weeks must have passed since the completion of prior therapy and receipt of the first dose of BMS-936558.
  • 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 open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Naiyer Rizvi at 646-888-4204.

Disease(s)
Lung Cancer
Lung Cancer, Non-Small Cell: Other
Locations