The purpose of this Phase Ib study is to test the safety of NG-monomethyl-L-arginine (L-NMMA)
and pembrolizumab when used together in participants with melanoma, non-small cell lung
cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), classical Hodgkin lymphoma
(cHL), urothelial carcinoma, Cervical Cancer, Esophageal Cancer, Gastric Cancer,
Hepatocellular Carcinoma, Merkel Cell Carcinoma, Primary Mediastinal Large B-cell Lymphoma,
Renal Cell Carcinoma, Small Cell Lung Cancer, microsatellite instability-high
(MSI-H)/mismatch repair deficient (dMMR) cancer or for the Treatment of Adult Patients with
Unresectable or Metastatic Tumor Mutational Burden-High Solid Tumors. Pembrolizumab is a type
of treatment that stimulates the immune system to attack cancer cells. The immune system is
normally the body's first defense against threats like cancer. However, sometimes cancer
cells produce signals like programmed death-1 (PD-1) that prevent the immune system from
detecting and killing them. Pembrolizumab blocks PD-1 so your immune system can detect and
attack cancer cells. To help further boost the cancer-fighting ability of your immune system,
L-NMMA will be used along with pembrolizumab. L-NMMA is a nitric oxide synthase inhibitor.
The presence of nitric oxide synthase in the area around the cancer cells blocks the
cancer-fighting ability of the immune system. Thus, the use of L-NMMA and pembrolizumab
together may make the immune system work harder to attack and destroy the cancer cells.
Phase:
Phase 1
Details
Lead Sponsor:
Jorge G. Darcourt The Methodist Hospital Research Institute