A Phase II Study of REGN2810 for Patients with Advanced Basal Cell Carcinoma that Persists Despite Vismodegib or Sonidegib

Full Title

R2810-ONC-1620: A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1, in Patients with Advanced Basal Cell Carcinoma who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

Purpose

Basal cell cancer of the skin may be treated with drugs such as vismodegib or sonidegib, but sometimes the cancer comes back or continues to grow. In this study, researchers are evaluating the safety and effectiveness of the investigational drug REGN2810 in patients with advanced basal cell skin cancer that persists despite treatment with vismodegib or sonidegib.

REGN2810 boosts the 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 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).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced basal cell skin cancer that has continued to grow despite treatment with vismodegib or sonidegib.
  • Patients may not have received any anticancer treatment other than radiation therapy in the 30-day period prior to entering the study. Prior treatment with a PD-1 inhibitor is not allowed.
  • 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.

For more information and to inquire about eligibility for this study, please contact Dr. Lara Dunn at 646-888-4233.

Protocol

17-391

Phase

II

Investigator

Co-Investigators