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Protocol No. UW16131

Principal Investigator Leal, Ticiana

Phase II

Age Group Adult

Scope National

Sponsor Type Industry

Title A Parallel Phase 2 Study of Glesatinib, Sitravatinib or mocetinostat in Combination With Nivolumab in Advanced or Metastatic Non-Small Cell Lung Cancer

Objective The purpose of this study is to find out if subjects with non-small cell lung cancer that is not responding to treatment with an immunotherapy alone will benefit from treatment by adding the investigational agent sitravatinib to nivolumab. Sitravatinib is an investigational drug. This means that sitravatinib has not been approved by the US Food and Drug Administration (FDA) for the treatment of the disease you have, and it can only be given in a research study.

Treatment Sitravatinib is an experimental drug that belongs to a class of drugs known as tyrosine kinase inhibitors. Sitravatinib is being developed as a possible treatment for different types of cancer. Sitravatinib is designed to block specific proteins that are thought to cause tumors to grow and to prevent growth of new blood vessels that help cancer tumors to grow and spread. In addition, research indicates that sitravatinib may help stimulate a subject's immune system, improving its ability to recognize and attack cancer cells. Nivolumab is an FDA approved, prescription drug that belongs to a class of drugs known as checkpoint inhibitors. Nivolumab can block these signal molecules, allowing the immune system to recognize and attack cancer cells.This study will evaluate whether the combination of immune system stimulation caused by sitravatinib and improved recognition of tumor cells caused by nivolumab results in more anti-tumor activity (tumor shrinkage) than would be expected with either agent used alone.

Description Sitravatinib will be provided as capsules. You will take sitravatinib once daily. Nivolumab will be administered by intravenous infusions (infusion of the liquid medication directly into your vein), in the clinic every 2 weeks.

Key Eligibility
  • Patients must have histologically confirmed non-squamous NSCLC with metastatic or unresectable, locally advanced disease, not amenable to treatment with curative intent
  • Patients must have had at least one prior treatment in the advanced disease setting: either a platinum-based doublet chemotherapy or treatment with a checkpoint inhibitor including nivolumab, pembrolizumab, durvalumab, atezolizumab or avelumab with the result of progression of disease on or after treatment
  • Patients are eligible if brain metastases are adequately treated and patients are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids, or on a stable or decreasing dose of less than or equal to 10 mg daily prednisone
  • Patients with carcinomatous meningitis are ineligible
  • Patients who test positive for EGFR,ROS1, ALK mutations or ALK fusions or any other mutations for which there are tyrosine kinase inhibitors available under development are ineligible
  • Patients with known HIV, acute or chronic hepatitis B are excluded; patients with a history of chronic hepatitis C that is no longer present will be eligible

Applicable Disease Sites Lung

Therapies Involved Cytotoxic Chemotherapy; Immunotherapy

Drugs Involved BMS-936558 (Nivolumab); Nivolumab; Opdivo (Nivolumab); Sitravatinib

Status Open

Participating Institutions UW Hospital and Clinics