Longitudinal Immune-phenotyping of HCC Following MK-3475
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|ClinicalTrials.gov Identifier: NCT04224480|
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : January 18, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Pembrolizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Longitudinal Immune-phenotyping of Surgically Resected HCC Following Neoadjuvant and Adjuvant Treatment With MK-3475|
|Actual Study Start Date :||December 10, 2019|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2023|
Neoadjuvant treatment will consist of one dose of IV pembrolizumab. Tumor resection will be performed approximately 4 weeks after neoadjuvant pembrolizumab. Adjuvant treatment with pembrolizumab will be administered 4 weeks after the surgery.
200mg of intravenous infusion every 3 weeks
Other Name: MK-3475
- Number of subjects with HCC recurrence [ Time Frame: 2 years after hepatic resection ]To evaluate the effect of neoadjuvant and adjuvant pembrolizumab on recurrence rate
- Number of CD8+ Ki67+ T cells found in resected tumour from subjects [ Time Frame: Up to 24 months after hepatic resection ]To compare the phenotype of immune cells in the tumor microenvironment after tumor resection from recurrence-free verses recurrent subjects receiving pembrolizumab
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04224480
|Contact: Han Chong Toh, MD||+65 6436 email@example.com|
|National Cancer Centre Singapore||Recruiting|
|Principal Investigator:||Han Chong Toh, MD||National Cancer Centre, Singapore|