Pembrolizumab (MK-3475) in Hepatocellular Carcinoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02940496
Phase
PHASE2
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Elbasvir/Grazoprevir — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Ribavirin — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Dec 9, 2016
Status verified
Jul 2025
Primary completion
Aug 9, 2023
Completion
Aug 9, 2023

Study Design

Enrollment
15 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (pembrolizumab)
    Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm B (pembrolizumab, elbasvir/grazoprevir, ribavirin)
    Patients receive pembrolizumab as in arm A. Patients also receive elbasvir/grazoprevir orally PO QD and ribavirin PO QD on days 1-28. Treatment continues for 12-16 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Correlation of HCC Stiffness to Overall Survival [ Time Frame: up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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M D Anderson Cancer Center· Houston, TX