NCT03211416

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

A Phase Ib/ II Study of Sorafenib and Pembrolizumab in Advanced Hepatocellular Cancer (HCC)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To assess the overall response rate (ORR) related to the combination of sorafenib tosylate (sorafenib) + pembrolizumab in advanced hepatocellular carcinoma patients. SECONDARY OBJECTIVES: I. To assess time to tumor progression in patients who received the combination therapy of sorafenib + pembrolizumab compared to historical data on sorafenib only treatment in patients with advanced hepatocellular carcinoma. TERTIARY OBJECTIVES: I. To obtain data on changes in immune cell function and in the tumor microenvironment pre- and post-treatment to screen for potential biomarkers that may be able to predict clinical benefit. \- All patients will be followed for survival OUTLINE: Patients receive sorafenib tosylate orally (PO) twice daily (BID) on days -28 to -1 and 1-21. Patients also receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, every 3 months for up to 1 year, then every 6 months thereafter.

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

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Pembrolizumab	Given IV
DRUG	Sorafenib Tosylate	Given PO

Timeline

• Start date: 2017-12-07
• Primary completion: 2023-03-07
• Completion: 2025-08-15
• First posted: 2017-07-07
• Last updated: 2026-02-05
• Results posted: 2024-05-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study