A Phase II Study of Combination Therapy with Pembrolizumab Immunotherapy for Advanced Non-Small Cell Lung Cancer

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Full Title

A Phase 2 Precision Oncology Study of Biomarker-Directed, Pembrolizumab- (MK-3475, SCH 900475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (KEYNOTE-495; KeyImPaCT)

Purpose

Pembrolizumab is an immunotherapy drug used to treat advanced non-small cell lung cancer (NSCLC) as well as other cancers. It works by inhibiting a protein cancer cells use to evade detection by the immune system, enabling the immune system to detect and destroy cancer cells. In this study, researchers are evaluating the safety and effectiveness of various drugs in combination with pembrolizumab: lenvatinib, MK-1308, or MK-4280.

Lenvatinib works by blocking an enzyme that helps cancer cells grow and develop blood vessels. Blocking this protein may slow the growth of the cancer cells and cut off the blood supply that feeds them. MK-1308 is an investigational drug that also boosts the immune response against cancer, but does so by blocking a protein called CTLA-4. MK-4280 is an investigational drug that blocks the LAG-3 protein, enabling the immune system to recognize cancer cells and kill them.

Patients will receive one of these drugs plus pembrolizumab. Before the treatment part of the study begins, research testing will be done on a sample of each patient’s tumor tissue to look for biomarkers (cells and proteins that could help predict how beneficial a treatment may be). This biomarker testing can take a few weeks to be completed and will be used to determine which treatment combination a patient receives.

Pembrolizumab, MK-1308, and MK-4280 are given intravenously (by vein), and lenvatinib is taken orally (by mouth).

Eligibility

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

  • Patients must have newly diagnosed metastatic NSCLC and have not yet received treatment for metastatic stage disease.
  • Patients may not have received prior 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

19-145

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators