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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

Adult

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