check_circleStudy Completed

Hepatocellular carcinoma

Regorafenib plus pembrolizumab in patients with advanced or spreading liver cancer who have been previously treated with PD-1/PD-L1 Immune Checkpoint Inhibitors

Trial purpose

Researchers are looking for a better way to treat people diagnosed with liver cancer which may have spread to nearby tissue and is unlikely to be cured or controlled with treatment (advanced metastatic hepatocellular carcinoma, HCC). Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.
In this trial, the researchers will learn more about the trial treatment, regorafenib, in a small number of participants. They will study the results when the trial treatment is taken with another cancer treatment called pembrolizumab.

There will be 2 parts to this trial. The part 1 (pilot phase) will include about 52 men and women. The part 2 (expansion phase) will include about 67 men and women. All of the participants will have HCC and will be aged 18 years or older. All of the participants will have tried other treatments that did not help their HCC. These other treatments (PD-1/PD-L1 Immune Checkpoint Inhibitors) are designed to work by stopping the activity of certain proteins in the immune system thought to play a role in HCC.
During both parts of the trial, the participants will take regorafenib and receive pembrolizumab. In the pilot phase, there will be 2 groups of participants. The group that each participant joins will be based on the treatment they already received for their HCC. The researchers will review the results in each group to learn if regorafenib and pembrolizumab are helping one group of participants more than others. Outcome of this review will determine the population to be treated in the expansion phase.

Key Participants Requirements

Sex

All

Age

18 - N/A

Trial summary

Enrollment Goal
95
Trial Dates
February 2021 - April 2024
Phase
Phase 2
Could I Receive a placebo
No
Products
Regorafenib/Pembrolizumab (BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
University of Florida-GainesvilleGainesville, 32610-0224, United States
Completed
Eberhard-Karls-Universität TübingenTübingen, 72076, Germany
Completed
Humanitas Mirasole S.p.A.Milano, 20089, Italy
Withdrawn
ASL Napoli 1 CentroNapoli, 80147, Italy
Completed
Istituto Oncologico Veneto_Padova - UOC Oncologia 1Padova, 35128, Italy
Completed
Klinikum der Universität München GrosshadernMünchen, 81377, Germany
Completed
Universitätsklinikum KölnKöln, 50937, Germany
Completed
Universitätsmedizin der Johannes Gutenberg Universität MainzMainz, 55101, Germany
Withdrawn
Universitätsklinikum Hamburg Eppendorf (UKE)Hamburg, 20246, Germany
Withdrawn
Medizinische Fakultät der Otto-von-Guericke UniversitätMagdeburg, 39120, Germany
Completed
University of California Irvine Medical CenterOrange, 92868-3201, United States
Completed
University of Miami Miller School of MedicineMiami, 33136, United States
Completed
Moffitt Cancer CenterTampa, 33612, United States
Completed
City of Hope - Duarte Cancer CenterDuarte, 91010, United States
Completed
Azienda Ospedaliero Universitaria Pisana_Santa Chiara - UO Oncologia 2Pisa, 56126, Italy
Completed
Asan Medical CenterSeoul, 05505, Korea,_republic_of
Completed
Samsung Medical CenterSeoul, 06351, Korea,_republic_of
Completed
Seoul National University HospitalSeoul, 3080, Korea,_republic_of
Completed
Seattle Cancer Care AllianceSeattle, 98109-1023, United States
Completed
University of Arizona Cancer CenterTucson, 85724, United States
Completed
Massachusetts General HospitalBoston, 02114-2696, United States
Completed
Tel-Aviv Sourasky Medical CenterTel Aviv, 6423906, Israel
Completed
Rabin Medical Center | Beilinson Hospital - Internal Medicine C DepartmentPetach Tikva, 4941492, Israel
Completed
Rambam Health CorporationHaifa, 3109601, Israel
Withdrawn
Hadassah Hebrew University Hospital Ein KeremJerusalem, 9112001, Israel
Completed
Heinrich-Heine-Universität DüsseldorfDüsseldorf, 40225, Germany
Completed
USC Norris Hospital and ClinicsLos Angeles, 90033, United States
Withdrawn
MedStar Georgetown University HospitalWashington, 20007-2197, United States
Withdrawn
Atrium Health Levine Cancer InstituteCharlotte, 28204, United States
Withdrawn
Stephenson Cancer CenterOklahoma City, 73104, United States
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 8036, Spain
Withdrawn
Ciutat Sanitaria i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Completed
Institut Català d'Oncologia HospitaletHospitalet de Llobregat, 08907, Spain
Completed
Hospital General Universitario Gregorio Marañón | DigestivoMadrid, 28007, Spain
Withdrawn
Clínica Universidad de Navarra CUNPamplona, 31008, Spain
Withdrawn
University of CaliforniaSanta Monica, 90404-2125, United States
Completed
Hôpital Paul Brousse - VillejuifVILLEJUIF, 94800, France
Completed
Hôpital de la Croix RousseLYON, 69004, France
Completed
Hopital Claude Huriez - LilleLILLE, 59037, France
Completed
Hôpital Beaujon - ClichyCLICHY, 92110, France
Completed
Centre François Magendie - PessacPESSAC, 33600, France
Completed
Center Hospitalier Michallon - GrenobleGRENOBLE CEDEX 9, 38043, France
Withdrawn
Kindai University HospitalOsakasayama-shi, 589-8511, Japan
Completed
Hôpital Saint-EloiMONTPELLIER CEDEX, 34059, France
Completed
National Cancer Center Hospital EastKashiwa, 277-8577, Japan
Completed
Chiba University HospitalChiba-shi, 260-8677, Japan
Withdrawn
Kyoto Prefectural University of MedicineKyoto, 602-8566, Japan
Withdrawn
Rocky Mountain Cancer Centers / Aurora, COAurora, 80012, United States
Completed
Medical Oncology Hematology Consultants, PANewark, 19713, United States
Withdrawn
Northwest Cancer Specialists, PC - PortlandPortland, 97227, United States
Completed
Japanese Red Cross Society Musashino Red Cross HospitalMusashino, 180-8610, Japan
Withdrawn
Hospital Clínico Universitario de Santiago de CompostelaSantiago de Compostela, 15706, Spain
Withdrawn
Texas Oncology, PA - Sammons Cancer CenterDallas, 75246, United States
Withdrawn
Texas Oncology- TylerTyler, 75702, United States
Withdrawn
Maryland Oncology Hematology - Silver SpringSilver Spring, 20904, United States
Completed
Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoMilano, 20122, Italy
Withdrawn
Ospedale San Raffaele s.r.l.Milano, 20132, Italy
Withdrawn
Azienda Ospedaliera Di Rilievo Nazionale Antonio CardarelliNapoli, 80131, Italy
Withdrawn
Seoul National University Bundang HospitalSeongnam-si, 13620, Korea,_republic_of
Withdrawn
A.O.U. Policlinico Paolo GiacconePalermo, 90127, Italy
Completed
Centre Hospitalier Universitaire de NancyVANDOEUVRE-LES-NANCY, 54500, France
Completed
AP-HM - Hopital de la TimoneMARSEILLE, 13005, France

Primary Outcome

  • Overall response rate (ORR) per RECIST 1.1 by central assessment
    Overall response rate (ORR) is defined as the percentage of participants with best overall response of confirmed complete response (CR) or partial response (PR). ORR per RECIST 1.1 by independent central assessment is reported). RECIST 1.1: response evaluation criteria in solid tumors version 1.1
    date_rangeTime Frame:
    Up to 15 months. Data up to 38 months are now available and are also reported for full transparency.
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Overall response rate (ORR) per RECIST 1.1 by investigator assessment
    Overall response rate (ORR) is defined as the percentage of participants with best overall response of confirmed complete response (CR) or partial response (PR). ORR by RECIST 1.1 investigator review is reported. RECIST 1.1: response evaluation criteria in solid tumors version 1.1
    date_rangeTime Frame:
    Up to 38 months
    enhanced_encryption
    Safety Issue:
    No
  • Duration of response (DOR) per RECIST 1.1 by central assessment and investigator assessment
    Duration of response (DOR) for partial response (PR) and complete response (CR) was defined as the time from the first documented objective response of PR or CR, whichever noted earlier, to disease progression or death (if death occurs before progression was documented). DOR was defined for confirmed responders only, i.e., participants with a CR or PR. RECIST 1.1: response evaluation criteria in solid tumors version 1.1
    date_rangeTime Frame:
    Up to 38 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events (AEs) and serious adverse events (SAEs)
    An AE was considered as treatment-emergent (TEAE) if arising or worsening after start of first study intervention administration until 30 days after administration of any study intervention. In addition, any AEs qualifying as a serious adverse event (SAE) were collected for 90 days after the last dose of pembrolizumab, unless a new anti-cancer therapy had been initiated.
    date_rangeTime Frame:
    Up to 38 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with safety-relevant changes in clinical parameters
    Number of participants with clinically relevant trends observed in laboratory data, ECG data, or ECOG performance status is reported.
    date_rangeTime Frame:
    Up to 38 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage of participants with dose modification
    Dose modification included dose interruption, dose reduction, dose discontinuation.
    date_rangeTime Frame:
    Up to 38 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

An Open-Label Study of Regorafenib in Combination with Pembrolizumab in Patients with Advanced or Metastatic Hepatocellular Carcinoma (HCC) after PD1/PD-L1 Immune Checkpoint Inhibitors
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
1