At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 15 enrolled
Drug / intervention
Elbasvir/Grazoprevir +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Pembrolizumab (MK-3475) in Hepatitis C Virus Positive and Negative Subjects With Advanced Hepatocellular Carcinoma Who Progressed on or Were Intolerant to First-Line Systemic Therapy
In Brief
A Phase 2 clinical trial evaluating Elbasvir/Grazoprevir, Laboratory Biomarker Analysis, and 2 other interventions for BCLC Stage B Hepatocellular Carcinoma and 10 related conditions. Completed, enrolled 15 participants across 1 site.
Detailed Summary
This will be a Phase II study investigating single agent pembrolizumab (Keytruda®) as a second-line therapy for subjects with hepatocellular carcinoma (HCC) who either progressed on or after sorafenib or did not tolerate sorafenib.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBCLC Stage B Hepatocellular Carcinoma, BCLC Stage C Hepatocellular Carcinoma, Hepatitis C Infection, Refractory Liver Carcinoma, Stage III Hepatocellular Carcinoma AJCC v7, Stage IIIA Hepatocellular Carcinoma AJCC v7, Stage IIIB Hepatocellular Carcinoma AJCC v7, Stage IIIC Hepatocellular Carcinoma AJCC v7, Stage IV Hepatocellular Carcinoma AJCC v7, Stage IVA Hepatocellular Carcinoma AJCC v7, Stage IVB Hepatocellular Carcinoma AJCC v7
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 2016
Enrollment StartDec 2016
Primary CompletionAug 2023
TodayJul 2026
First PostedOct 21, 2016
Enrollment StartDec 9, 2016
Primary CompletionAug 9, 2023
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 9.7 years ago
Interventions
Elbasvir/Grazoprevirdrug
Given PO
Laboratory Biomarker Analysisother
Correlative studies
Pembrolizumabbiological
Given IV
Ribavirindrug
Given PO