0482 Device Protocol of PD-L1 IHC 22C3 pharmDx TNBC
Research type
Research Study
Full title
Device Protocol of PD-L1 IHC 22C3 pharmDx on Triple-Negative Breast Cancer Specimens
IRAS ID
299858
Contact name
Jeremy Thomas
Contact email
Sponsor organisation
Merck Sharpe & Dohme Corp., a subsidiary of Merck & Co., Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 27 days
Research summary
In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. Immunohistochemistry (IHC) is used to help diagnose diseases, such as cancer. It may also be used to help tell the difference between different types of cancer. Cytotoxic T cells work to detect and eliminate infected cells and tumor cells from the body. To limit damage to surrounding tissue, normal cells differentiate themselves by expressing a protein signal called PD-L1 (programmed death ligand 1). This PD-L1 signal is a stop sign designed to avoid elimination of normal cells by cytotoxic T cells.
PD-L1 expression status is one of several criteria used to prospectively select and enroll patients into the medicinal clinical trial. Agilent Technologies, the device manufacturer, has developed a qualitative IHC assay. The name of the device is called “PD-L1 IHC 22C3 pharmDx”, which is to be used for testing of clinical specimens to evaluate PD-L1 protein expression. PD-L1 protein expression in breast cancer is determined by using Combined Positive Score (CPS), which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. The clinical evaluation of PD-L1 IHC 22C3 pharmDx is not a separate research study but is part of the clinical trial designed for drug testing.
Agilent Technologies is submitting this device protocol for the use of PD-L1 IHC 22C3 pharmDx to determine PD-L1 expression in human TNBC tissue patient specimens in the Merck sponsored clinical study MK-0482-001.
REC name
HSC REC A
REC reference
21/NI/0136
Date of REC Opinion
31 Aug 2021
REC opinion
Favourable Opinion