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Pembrolizumab (MK-3475) in Hepatocellular Carcinoma

NCT02940496 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-07-15

Study results available
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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.

Conditions

  • BCLC 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

Interventions

DRUG

Elbasvir/Grazoprevir

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Pembrolizumab

Given IV

DRUG

Ribavirin

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Ahmed O Kaseb, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-09
Primary Completion
2023-08-09
Completion
2023-08-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02940496 on ClinicalTrials.gov