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Sorafenib Tosylate and Pembrolizumab in Treating Patients With Advanced or Metastatic Liver Cancer

NCT03211416 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-02-05

Study results available
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Summary

This phase Ib/II trial studies how well sorafenib tosylate and pembrolizumab work in treating patients with liver cancer that has spread to other parts of the body. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving sorafenib tosylate and pembrolizumab may work better in treating patients with liver cancer.

Conditions

  • Advanced Adult Hepatocellular Carcinoma
  • Child-Pugh Class A
  • Stage III Hepatocellular Carcinoma
  • Stage IIIA Hepatocellular Carcinoma
  • Stage IIIB Hepatocellular Carcinoma
  • Stage IIIC Hepatocellular Carcinoma
  • Stage IV Hepatocellular Carcinoma
  • Stage IVA Hepatocellular Carcinoma
  • Stage IVB Hepatocellular Carcinoma

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Pembrolizumab

Given IV

DRUG

Sorafenib Tosylate

Given PO

Sponsors & Collaborators

Principal Investigators

  • Kannan Thanikachalam, MD · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-07
Primary Completion
2023-03-07
Completion
2025-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03211416 on ClinicalTrials.gov