check_circleStudy Completed

Carcinoma, Hepatocellular

Regorafenib plus pembrolizumab in first line systemic treatment of HCC

Trial purpose

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

Key Participants Requirements

Sex

All

Age

18 - N/A

Trial summary

Enrollment Goal
58
Trial Dates
June 2018 - September 2022
Phase
Phase 1
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Universitätsmedizin der Johannes Gutenberg Universität MainzMainz, 55131, Germany
Completed
Universitätsklinikum KölnKöln, 50937, Germany
Completed
Seattle Cancer Care AllianceSeattle, 98109-1023, United States
Completed
Mount Sinai Medical CenterNew York, 10029, United States
Completed
USC Norris Hospital and ClinicsLos Angeles, 90033, United States
Completed
H. Lee Moffitt Cancer Center & Research InstituteTampa, 33612, United States
Completed
University of Florida Health Sciences CenterGainesville, 32608, United States

Primary Outcome

  • Incidence of treatment-emergent adverse event(TEAEs)
    The incidence of treatment-emergent adverse events and treatment-emergent drug-related adverse events summarized in frequency tables using worst CTCAE v4.03 grade.
    date_rangeTime Frame:
    Up to 30 days after last dose of study drug
  • Severity of TEAEs
    date_rangeTime Frame:
    Up to 30 days after last dose of study drug
  • Dose Limiting Toxicities(DLTs)
    date_rangeTime Frame:
    Up to 42 days after first treatment administration

Secondary Outcome

  • Maximum Tolerated Dose (MTD)
    The MTD is defined as the highest dose that can be given so that toxicity probability is below the target toxicity PT =35%.
    date_rangeTime Frame:
    After approximately 18 months
  • Progression-free survival (PFS)
    date_rangeTime Frame:
    After approximately 36 months
  • Time to progression (TTP)
    date_rangeTime Frame:
    After approximately 36 months
  • Overall survival (OS)
    date_rangeTime Frame:
    After approximately 36 months
  • Overall response rate (ORR)
    date_rangeTime Frame:
    After approximately 36 months
  • Disease control rate (DCR)
    date_rangeTime Frame:
    After approximately 36 months
  • Duration of response (DOR)
    date_rangeTime Frame:
    After approximately 36 months
  • Duration of stable disease
    date_rangeTime Frame:
    After approximately 36 months

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
2