Full TitleA Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients with Advanced Cutaneous Squamous Cell Carcinoma
The purpose of this study is to assess the safety and effectiveness of the investigational immunotherapy drug REGN2810 in patients with advanced cutaneous (skin) squamous cell carcinoma that is either in the skin only but is inoperable, or has spread (metastasized) beyond the skin to other parts of the body.
REGN2810 boosts the body’s immune system by targeting a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this shut-down mechanism by activating PD-1, enabling them to escape attack by the body’s white blood cells. REGN2810 binds to and inactivates PD-1, enhancing the body’s ability to detect and destroy cancer cells. It is given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have advanced cutaneous squamous cell carcinoma that is localized and inoperable or has metastasized.
- Patients with an underlying blood cancer, such as chronic lymphocytic leukemia, may not participate.
- Prior anticancer treatment must have been completed at least 30 days before entering the study.
- Patients may not have previously received a PD-1 inhibitor.
- 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.