Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1/PD-L1 Immune Checkpoint Inhibitors

PHASE2CompletedINTERVENTIONAL
Enrollment

95

Participants

Timeline

Start Date

February 3, 2021

Primary Completion Date

May 5, 2022

Study Completion Date

April 23, 2024

Conditions
Hepatocellular Carcinoma
Interventions
DRUG

Pembrolizumab

Pembrolizumab 400 mg to be administered as an intravenous (IV) infusion every 6 weeks (Q6W).

DRUG

Regorafenib (Stivarga, BAY73-4506)

Regorafenib to be given orally (p.o.) at a starting dose of 90 mg QD for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily is well tolerated the dose should be escalated to 120 mg starting after the first 4-week cycle of regorafenib.

Trial Locations (39)

3080

Seoul National University Hospital, Seoul

8036

Hospital Clínic i Provincial de Barcelona, Barcelona

13005

AP-HM - Hopital de la Timone, Marseille

19713

Medical Oncology Hematology Consultants, PA, Newark

20089

Humanitas Mirasole S.p.A., Milan

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

33136

University of Miami Miller School of Medicine, Miami

33600

Centre François Magendie - Pessac, Pessac

33612

Moffitt Cancer Center, Tampa

34059

Hôpital Saint-Eloi, Montpellier

35128

Istituto Oncologico Veneto_Padova - UOC Oncologia 1, Padua

38043

Center Hospitalier Michallon - Grenoble, Grenoble

40225

Heinrich-Heine-Universität Düsseldorf, Düsseldorf

50937

Universitätsklinikum Köln, Cologne

54500

Centre Hospitalier Universitaire de Nancy, Vandœuvre-lès-Nancy

55101

Universitätsmedizin der Johannes Gutenberg Universität Mainz, Mainz

56126

Azienda Ospedaliero Universitaria Pisana_Santa Chiara - UO Oncologia 2, Pisa

59037

Hopital Claude Huriez - Lille, Lille

69004

Hôpital de la Croix Rousse, Lyon

72076

Eberhard-Karls-Universität Tübingen, Tübingen

81377

Klinikum der Universität München Grosshadern, München

85724

University of Arizona Cancer Center, Tucson

90033

USC Norris Hospital and Clinics, Los Angeles

91010

City of Hope - Duarte Cancer Center, Duarte

92110

Hôpital Beaujon - Clichy, Clichy

94800

Hôpital Paul Brousse - Villejuif, Villejuif

3109601

Rambam Health Corporation, Haifa

6423906

Tel-Aviv Sourasky Medical Center, Tel Aviv

92868-3201

University of California Irvine Medical Center, Orange

02114-2696

Massachusetts General Hospital, Boston

98109-1023

Seattle Cancer Care Alliance, Seattle

Unknown

"Rabin Medical Center , Beilinson Hospital - Internal Medicine C Department"

"Hospital General Universitario Gregorio Marañón , Digestivo"

260-8677

Chiba University Hospital, Chiba

277-8577

National Cancer Center Hospital East, Kashiwa

180-8610

Japanese Red Cross Society Musashino Red Cross Hospital, Musashino

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08907

Institut Català d'Oncologia Hospitalet, L'Hospitalet de Llobregat

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Bayer

INDUSTRY

NCT04696055 - Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1/PD-L1 Immune Checkpoint Inhibitors | Biotech Hunter | Biotech Hunter