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GRN-1201-002 A Pilot, Open-Label, Multi-Center, Multi-Dose Study of GRN-1201 Added to Pembrolizumab in Subjects with Non-Small Cell Lung Cancer with High PD-L1 Expression

NCT03417882

A Pilot, Open-Label, Multi-Center, Multi-Dose Study of GRN-1201 Added to Pembrolizumab in Subjects with Non-Small Cell Lung Cancer with High PD-L1 Expression

Associated Conditions

Lung Cancer

Principal Investigator

Sponsor

BrightPath Biotherapuetics

The study drug is known as GRN-1201 and is a type of cancer vaccine made up of four peptides (short chains of amino acids) that can cause an immune system response against cancer cells. Amino acids are what make up proteins. The study drug is being tested in this study when added to pembrolizumab, an approved medicine to treat a kind of lung cancer called non-small cell lung cancer (NSCLC) which has spread (metastatic), because it may cause a response by the immune system against the tumor. GRN-1201 is considered an investigational drug. An investigational drug is one that is not approved by the Food and Drug Administration (FDA) for use or sale in the United States. This will be the first study of GRN-1201/sargramostim in combination with pembrolizumab in humans. The study team wants to find out what effects, good or bad, this combination has on people with newly diagnosed metastatic NSCLC expressing PD-L1 and whose tumor biopsy samples express PD-L1.

This study is currently enrolling.