Pembrolizumab Plus Y90 Radioembolization in HCC Subjects

Summary

This is an open-label multi-center trial designed to evaluate the efficacy as well as the safety of combining pembrolizumab with Yttrium-90 (Y90) radioembolization in subjects with poor prognosis (high risk) HCC not eligible for liver transplant or surgical resection with well compensated liver function. Treatment will consist of pembrolizumab 200mg IV every 3 weeks in conjunction with Y90 radioembolization performed one week after the first dose of pembrolizumab. If bilobar disease is present, a second Y90 radioembolization will be performed no later than 4 weeks after the first procedure to the contralateral hepatic lobe.

Timeline

Start

2017-03-28

Primary completion

2021-05-19

Completion

2023-06

Publications

• Yu S, Yu M, Keane B, Mauro DM, Helft PR, Harris WP, Sanoff HK, Johnson MS, O'Neil B, McRee AJ, Somasundaram A. A Pilot Study of Pembrolizumab in Combination With Y90 Radioembolization in Subjects With Poor Prognosis Hepatocellular Carcinoma. Oncologist. 2024 Mar 4;29(3):270-e413. doi: 10.1093/oncolo/oyad331.

Drugs

Indications