KRT-232-103-Phase 1b/2 OLE Study Evaluating the Safety and Efficacy of KRT-232
Research type
Research Study
Full title
A Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy 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, or in Combination with Avelumab in MCC Patients who are Anti-PD-1 or Anti-PD-L1 Treatment Naïve
IRAS ID
1004144
Contact name
Patricia Ryan
Contact email
Sponsor organisation
Kartos Therapeutics, Inc.
Eudract number
2020-002820-35
Clinicaltrials.gov Identifier
Research summary
Merkel cell carcinoma (MCC) is a rare, aggressive skin cancer with a poor prognosis in patients with advanced disease, in fact worse than that of malignant melanoma. For all stages of MCC, just over one-half of patients will die from the disease within 5 years. Patients with MCC who failed previous treatment or have not received any treatment with immunotherapy have limited treatment options. This a study to work out how well a new targeted oral medication works for patients with advanced MCC that has worsened despite immunotherapy treatment, or alongside immunotherapy in patients who have not yet received drug treatment for their disease. Only patients with a particular genetic profile within their MCC will be suitable for this study.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
21/EE/0241
Date of REC Opinion
1 Nov 2021
REC opinion
Unfavourable Opinion