A Phase II Study of Immunotherapy with AST-008 plus Pembrolizumab in People with Merkel Cell Carcinoma that Persists Despite Prior Immunotherapy

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Full Title

A Phase 1b/2 Study of AST-008 Combined with Pembrolizumab in Patients with Advanced Solid Tumors

Purpose

Merkel cell carcinoma (MCC) is a type of skin cancer. There are several types of immunotherapy used to treat this cancer, such as pembrolizumab and avelumab. They work by enhancing the ability of the immune system to find and kill cancer cells. However, sometimes MCC becomes resistant to immunotherapy and continues to grow.

The purpose of this study is to assess the safety and effectiveness of combining the investigational drug AST-008 with pembrolizumab in patients with advanced inoperable MCC that continues to grow despite immunotherapy. AST-008 stimulates TLR9, a protein that plays a role in the immune system’s defenses against cancer, infection, and tissue damage. By boosting the effects of TLR9, AST-008 might help to kill cancer cells, especially when given with pembrolizumab. AST-008 is injected into tumors and pembrolizumab 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 Merkel cell carcinoma that did not respond to immunotherapy.
  • Patients must have a tumor that can be felt so doctors know where to inject AST-008.
  • 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 646-888-4312.

Protocol

20-174

Phase

I/II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators