Clinical trial compares interval dosing of two immune checkpoint inhibitors

Immune Checkpoint Inhibitor (PD-1)

Immune checkpoint inhibitor. Checkpoint proteins, such as PD-L1 on tumor cells and PD-1 on T cells, help keep immune responses in check. The binding of PD-L1 to PD-1 keeps T cells from killing tumor cells in the body (left panel). Blocking the binding of PD-L1 to PD-1 with an immune checkpoint inhibitor (anti-PD-L1 or anti-PD-1) allows the T cells to kill tumor cells (right panel).
Image source: Terese Winslow via NCI Visuals Online

Adults with advanced or metastatic cancer that has not been previously treated with an immune checkpoint inhibitor may be eligible to participate in a clinical trial at the NIH Clinical Center.

William D. Figg Sr., Pharm.D., Deputy Chief of the Genitourinary Malignancies Branch, is leading CCR’s efforts in a multi-institution, international study comparing methods of dosing nivolumab and pembrolizumab. Both drugs are known as immune checkpoint inhibitors (ICIs) and work by releasing a natural “brake” on the immune system so that immune cells, called T cells, can recognize and attack tumors. T cells are an essential element of the immune system, and one of their jobs is to recognize, attack and kill certain cancer cells. The problem is that cancer cells can evolve proteins to protect themselves from T cells. Nivolumab and pembrolizumab block a protective protein, called PD-1, that prevents T cells from recognizing and attacking cancer cells. By blocking PD-1, ICIs increase the immune system’s ability to attack cancer cells and tumors. The goal of this study is to see if extending the time between doses of nivolumab or pembrolizumab can have the same therapeutic effect as standard dosing while potentially reducing costs. Participants must have advanced or metastatic cancer that has not been previously treated with an ICI. identifier: NCT04295863

NCI Protocol ID: NCI-00-0-103

Official Title: A Randomized Study Investigating the Pharmacokinetics of Standard Interval Dosing Compared to Extended Interval Dosing of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers

The Center for Cancer Research is NCI’s internal cancer center, a publicly funded organization working to improve the lives of cancer patients by solving important, challenging and neglected problems in cancer research and patient care. Highly trained physician-scientists develop and carry out clinical trials to create the medicines of tomorrow treating patients at the world’s largest dedicated research hospital on the campus of the National Institutes of Health in Bethesda, Maryland.

For more information on CCR clinical trials click here, and subscribe to have the latest CCR clinical trials sent directly to your inbox.

Posted on Tue, 02/15/2022