A Phase 2, Open-Label, Single-Arm 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

General Information Age Group Adults Status Recruiting Protocol Number NCT03787602 Background Information For participants diagnosed with Merkel cell carcinoma (MCC) and prior treatment with anti-PD-1 or anti-PD-L1 was not or is no longer effective. This is the first study of KRT-232 in patients with MCC after prior treatment with anti-PD-1 or anti-PD-L1 and it will evaluate how well tolerated KRT-232 is when given to participants with MCC, and whether KRT-232 can improve MCC outcomes. KRT-232 (formerly called AMG 232) is an investigational drug in a tablet form that is taken by mouth. KRT-232 has been shown in the laboratory to inhibit the growth of some tumor cells.   Offered At Inova Schar Cancer Institute 8081 Innovation Park Drive Fairfax, VA 22031 A department of Inova Fairfax Hospital Eligibility Information ECOG performance status of 0 to 1 Histologically confirmed MCC. Disease must be measurable, with at least 1 measureable lesion Merkel Cell Carcinoma expressing p53WT based on any CLIA or FDA approved test Subjects must have failed (i.e., relapsed or were refractory to) treatment with at least one PD-1 inhibitor or PD-L1 inhibitor for MCC Additional eligibility information in protocol Ineligibility Information Toxicity from prior radiation therapy that has not resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 0 or Grade 1 (with the exception of Grade 2 alopecia) Radiation therapy within 2 weeks prior to the first dose of KRT-232 Prior treatment for MCC with histone deacetylase (HDAC) inhibitors or BCL-2 inhibitors Patients previously treated with MDM2 antagonist therapies or p53-directed therapies Women who are pregnant or breastfeeding History of major organ transplant Additional exclusion criteria in protocol For more information go to: https://clinicaltrials.gov/ct2/show/NCT03787602 Contact Information Contact Name Kelly Jeffords Contact Phone 571-472-0631 Contact Email Send Email