Neoadjuvant Nivolumab, or Nivolumab in combination with Ipilimumab, in Resectable Non-Small-Cell Lung Cancer
Johns Hopkins Bayview Medical Center
Johns Hopkins Kimmel Cancer Center in Baltimore
To study the safety,feasibility, and tumor response when giving nivolumab (a form of immunotherapy) to patients with resectable high-risk non-small-cell lung cancer (NSCLC)in the pre-operative setting. To learn about the effects of nivolumab on tumor tissue and normal lung tissue.
biopsy confirmed NSCLC, either squamous or non-squamous cell allowed biopsy specimen must be available for pathology review Stage IB, II, or IIIA deemed suitable for primary curative surgical resection good physical condition with good blood counts and organ function no active or history of autoimmune disease or requirement for systemic steroids no prior chemotherapy or other cancer therapy in the pre-operative period disease-free of any prior malignancy for at least 2 years no brain metastases no history of interstitial lung disease or requirement for oxygen no vaccines allowed within 4 weeks of starting study no active infections requiring therapy, negative for Hepatitis B and C, HIV no prior immunotherapy
Patients will receive pre-operative nivolumab (a human monoclonal antibody that binds to PD-1 blocking interaction with PD-L1 and PD-L2)IV on days -28 and -14 prior to planned surgery on day 0. Several ancillary blood tests will be collected throughout the trial. A tumor biopsy will be obtained prior to surgery. Patients will have a follow up visit 3-6 weeks following surgery.
03/05/2019 05:03 AM