Regorafenib Plus Pembrolizumab in First Line Systemic Treatment of HCC

PHASE1CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

June 18, 2018

Primary Completion Date

December 17, 2020

Study Completion Date

September 6, 2022

Conditions
Carcinoma, Hepatocellular
Interventions
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

Trial Locations (7)

10029

Mount Sinai Medical Center, New York

32608

University of Florida Health Sciences Center, Gainesville

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

50937

Universitätsklinikum Köln, Cologne

55131

Universitätsmedizin der Johannes Gutenberg Universität Mainz, Mainz

90033

USC Norris Hospital and Clinics, Los Angeles

98109-1023

Seattle Cancer Care Alliance, Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Bayer

INDUSTRY