A Phase II Study of KRT-232 in Merkel Cell Carcinoma That Has Not Responded to Immunotherapy

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Full Title

A Phase 2, Open-Label Study of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy

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.

In this study, researchers are studying the safety and effectiveness of the investigational drug KRT-232 in patients with MCC that is growing despite immunotherapy. KRT-232 has been shown to block the growth of cancer cells that contain a normal version of a protein called p53. Patients in this study will therefore need to have MCC that contains a normal version of the p53 protein. KRT-232 is taken orally (by mouth).

Eligibility

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

  • Patients must have MCC that has stopped responding to immunotherapy with a PD-1 or PD-L1 inhibitor, such as pembrolizumab or avelumab.
  • Patients’ tumors must contain a normal (not mutated) version of the p53 protein.
  • At least 4 weeks must pass between the completion of previous treatment (2 weeks since radiation therapy) and entry into the study.
  • 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 646-888-4312.

Protocol

19-240

Phase

II

Investigator

Co-Investigators

Diseases