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Brief Title: RP3 in Combination With 1L or 2L Therapy in Patients With Locally Advanced Unresectable or Metastatic HCC
Official Title: A Phase 2, Open-label, Multicenter Study Investigating RP3 Oncolytic Immunotherapy in Combination With First- or Second-line Therapy in Patients With Locally Advanced Unresectable or Metastatic Hepatocellular Carcinoma
Study ID: NCT05733598
Brief Summary: This is a Phase 2, open-label, 2-cohort clinical study evaluating RP3 in combination with atezolizumab plus bevacizumab as First- or Second-line Systemic Therapy in patients with locoregionally advanced and/or metastatic Hepatocellular Carcinoma not amenable to surgical resection or standard locoregionally directed therapies.
Detailed Description: RP3 is a genetically modified herpes simplex type 1 virus (HSV-1) that expresses exogenous genes (anti-CTLA-4 antibody, CD40 ligand and h4-1BBL) designed to directly kill tumor cells and generate a systemic anti-tumor immune response
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California San Diego, UCSD, La Jolla, California, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
University of Cincinnati, Cincinnati, Ohio, United States
University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
West Cancer Center, Germantown, Tennessee, United States
University of Washington Fred Hutchinson Cancer Center, Seattle, Washington, United States
Hôpital BEAUJON, Clichy, , France
Université Claude Bernard Lyon 1, Centre Hospitalier Lyon Sud, Lyon, , France
CHU Bordeaux, Pessac, , France
Centre Eugène MARQUIS, Rennes, , France
Service d'Ocologie Digestive et Medicale Hopital Paul Brousse, Villejuif, , France
Institute Gustave Roussy Paris, Villejuif, , France
Krankenhaus Nordwest, Frankfurt, , Germany
Uniklinikum Heidelberg National Center for Tumors Heidelberg (NCT), Heidelberg, , Germany
University Hospital Leipzig Clinic and Polyclinic for Oncology, Gastroenterology, Hepatology, Pneumatology, Infectiology, Leipzig, , Germany
Universitätsklinikum Mainz Hautklinik und Poliklinik, Mainz, , Germany
"Hippocration" General Hospital of Athens, B' Department of Internal Medicine, Hepatogastroenterology Unit, Athens, , Greece
University General Hospital of Herakleion, Heraklion, , Greece
Leeds Teaching Hospital NHS Trust / St James's University Hospital, Leeds, , United Kingdom
Clatterbridge Cancer Center NHS Foundation Trust, Liverpool, , United Kingdom
Royal Free London NHS Foundation Trust, London, , United Kingdom
King's College Hospital, London, , United Kingdom
Oxford University Hospitals NHS Foundation Trust, Oxford, , United Kingdom
Name: Jaroslaw Jac, MD
Affiliation: Replimune Inc.
Role: STUDY_CHAIR