Longitudinal Immune-phenotyping of HCC Following MK-3475
Status:
Recruiting
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
Summary
The study comprises a main study of pembro-treated HCC patients and a sub-study of untreated
HCC patients. In the main study, patients will be treated with pembrolizumab as neoadjuvant
treatment approximately 4 weeks prior scheduled surgery. Adjuvant treatment with
pembrolizumab with commence at approximately 4 weeks post-surgery for up to 12 months.
Subjects will be followed up for a further 12 months after end of treatment for recurrence
and survival.
The sub-study is a tumour sample collection study which will provide pre-treatment immune
microenvironment data from up to 15 pairs of HCC/adjuvant liver tissue samples. Translational
analyses performed for liver tissue samples in the sub-study will be harmonized with the
analyses on liver tissue samples collected in the main study.
Phase:
Phase 1
Details
Lead Sponsor:
National Cancer Centre, Singapore
Collaborators:
Merck Sharp & Dohme Corp. National Medical Research Council (NMRC), Singapore