A Phase III Study of Avelumab Immunotherapy versus Placebo in Patients with Merkel Cell Carcinoma that Spread to the Lymph Nodes

Full Title

CC9820: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 3 Trial of Adjuvant Avelumab (Anti-PDL-1 antibody) in Merkel Cell Carcinoma Patients with Clinically Detected Lymph Node Metastases

Purpose

Avelumab is an immunotherapy drug that works by blocking a protein in 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 find and destroy a cancer.

Avelumab is approved for treating metastatic Merkel cell cancer. In this study, researchers are evaluating its effectiveness for reducing the risk of cancer recurrence in patients with Merkel cell cancer that has been surgically removed but has spread to the lymph nodes and has a high risk of coming back. Avelumab is given intravenously (by vein).

Patients in this study will be randomly assigned to receive either avelumab or a placebo (inactive drug), and researchers will compare the two groups.

Eligibility

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

  • Patients must have Merkel cell cancer that has been surgically removed and, prior to the surgery, could be felt in the lymph nodes or seen in the lymph nodes on imaging scans.
  • Patients may not have previously received systemic therapy (chemotherapy or immunotherapy) for their cancer.
  • 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 Dr. Ciara Kelly at 646-888-4159.

Protocol

18-093

Phase

III

Investigator

Co-Investigators

Diseases