NCT04224480

Longitudinal Immune-phenotyping of HCC Following MK-3475

Longitudinal Immune-phenotyping of Surgically Resected HCC Following Neoadjuvant and Adjuvant Treatment With MK-3475

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	200mg of intravenous infusion every 3 weeks

Timeline

• Start date: 2019-12-10
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2020-01-13
• Last updated: 2024-01-19

Locations

1 site across 1 country: Singapore