NCT04442581

Cabozantinib and Pembrolizumab for the First-Line Treatment of Advanced Liver Cancer

A Phase 2 Trial of Cabozantinib and Pembrolizumab in the First-Line Treatment of Advanced Hepatocellular Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well cabozantinib and pembrolizumab work for the first-line treatment of patients with liver cancer who are not eligible for local therapy (i.e. advanced stage). Cabozantinib may stop the growth of tumor cells by blocking some cell surface receptors and signaling pathways inside the tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer. Giving cabozantinib and pembrolizumab together may work better in treating patients with advanced liver cancer compared to cabozantinib or pembrolizumab alone.

Detailed description

OUTLINE: Patients receive cabozantinib S-malate orally (PO) once daily (QD) on days 1-21 and pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Disease assessment by imaging will be performed every 9 weeks.

Conditions

• Advanced Hepatocellular Carcinoma
• BCLC Stage B Hepatocellular Carcinoma
• BCLC Stage C Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Cabozantinib S-malate	Given PO
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2021-04-20
• Primary completion: 2021-12-13
• Completion: 2022-03-08
• First posted: 2020-06-22
• Last updated: 2023-04-05
• Results posted: 2023-04-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study