A Phase II Study of Radiation Therapy with or without Avelumab in People with Advanced Merkel Cell Carcinoma

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Full Title

A Phase II Randomized Parallel Two-Arm Clinical Trial Assessing Comprehensive Ablative Radiation Therapy with or without Avelumab in Unresectable and Metastatic Merkel Cell Carcinoma (CARTA)

Purpose

The purpose of this study is to assess the safety and effectiveness of comprehensive ablative radiation therapy (CART) with or without the immunotherapy drug avelumab in patients with inoperable or metastatic Merkel cell carcinoma (MCC) that has continued to grow despite prior immunotherapy. Patients will be randomly assigned to receive CART on its own or in combination with avelumab. 

CART is a type of radiation therapy that treats all metastatic tumors throughout the body. Three CART treatments are given over 5 to 14 days. Avelumab is a type of drug called a PD-L1 inhibitor; it blocks a protein found on tumor cells and some immune cells, where the protein acts as a shield that prevents cancer cells from being attacked by the immune system. When avelumab attaches to PD-L1, it can break up the protective shield and help the immune system detect and destroy cancer cells. 

Avelumab and CART are each used individually to treat MCC; their use in combination is considered investigational. 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 inoperable or metastatic MCC that continued to grow 10 or more weeks after starting prior immunotherapy.
  • Patients may not have received chemotherapy for advanced MCC.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Christopher Barker at 212-639-8168.

Protocol

20-195

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators