NCT03347292

Regorafenib Plus Pembrolizumab in First Line Systemic Treatment of HCC

A Multicenter, Non-randomized, Open-label Dose Escalation Phase Ib Study of Regorafenib in Combination With Pembrolizumab in Patients With Advanced Hepatocellular Carcinoma (HCC) With no Prior Systemic Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will determine if the combination of regorafenib and pembrolizumab is safe and tolerated in patients with advanced liver cancer. In addition, the study will explore the anti-tumor activity of this combination as well as potentially identifying blood and tissue biomarkers associated with disease activity, status or response. The study will also investigate how the drugs behave in your body

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	Regorafenib(Stivarga, BAY73-4506)	Regorafenib 80mg/120mg/160mg q.d., 3 weeks on / 1 week off + pembrolizumab 200mg i.v. every 3 weeks
DRUG	Pembrolizumab	200 mg i.v.(Intravenous(ly)) every 3 weeks (Q3W). This dose will not be escalated or deescalated and the dosing schedule will not be changed

Timeline

• Start date: 2018-06-18
• Primary completion: 2020-12-17
• Completion: 2022-09-06
• First posted: 2017-11-20
• Last updated: 2023-07-25

Locations

7 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study