A Phase II Study of Avelumab Immunotherapy in Patients with Merkel Cell Carcinoma

Full Title

A Phase II, Open-label, Multicenter Trial to Investigate the Clinical Activity and Safety of Avelumab (MSB0010718C)in Subjects with Merkel Cell Carcinoma

Purpose

Merkel cell carcinoma is a rare and aggressive cancer that can occur on or just below the skin, and can be challenging to treat. In this study, researchers are assessing the safety and effectiveness of the investigational drug avelumab (MSB0010718C) in patients with Merkel cell carcinoma that has spread and has continued to grow despite therapy.

Avelumab is an antibody that works by blocking a protein on tumor cells called PD-L1. Tumor cells make PD-L1 to help them evade being detected by the immune system. By blocking this protein, Avelumab may improve the ability of the immune system to destroy a cancer. Avelumab 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 Merkel cell carcinoma that has spread and continues to grow despite no more than one prior regimen of therapy for metastatic disease.
  • At least 4 weeks must pass between the completion of prior anticancer therapy and entry into the study.
  • Patients who have had prior immunotherapy may not participate.
  • 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 about this study and to inquire about eligibility, please contact the Immunotherapeutics Clinic at 646-888-3359 or Dr. Sandra P. D'Angelo at 646-888-4159.

Protocol

14-160

Phase

II

Investigator

Co-Investigators