Study of Pembrolizumab in Metastatic HER2-negative Breast Cancer Patients With APOBEC3B Mutation
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
This is an open label investigator initiated Phase II study of single agent pembrolizumab
(Keytruda) in metastatic HER2-receptive negative breast cancer patients with germline
deletion in the cytosine deaminase (APOBEC3B) gene. Approximately 44 subjects from Malaysia
and Singapore will be enrolled in this study to examine the efficacy of pembrolizumab when
given 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 administrations (2 years).
This study will be conducted in conformance with Good Clinical Practices. Specific procedures
to be performed during the trial, as well as their prescribed times and associated visit
windows, are outlined in the Trial Flow Chart.
Phase:
Phase 2
Details
Lead Sponsor:
University of Malaya
Collaborators:
Cancer Research Malaysia Clinical Research Malaysia Merck Sharp & Dohme (MSD) Merck Sharp & Dohme Corp. National University Hospital, Singapore