127
Participants
Start Date
February 5, 2016
Primary Completion Date
February 14, 2022
Study Completion Date
July 11, 2023
Talimogene Laherparepvec
Talimogene laherparepvec (T-VEC) administered by intralesional injection into liver tumors, with ultrasound/computed tomography (US/CT) guidance. Part 1: initial dose of T-VEC is 10\^6 plaque forming unit (PFU)/mL up to 4mL in Cohorts 1 \& 2, up to 8mL in Cohorts 3 \& 4 of the Group A \& Group B. The 1st cycle of T-VEC will be 21 (+3) days (from the 1st dose at 10\^6 PFU/mL to the 2nd dose at 10\^7 or 10\^8 PFU/mL). Subsequent cycles of T-VEC will be 21 (±3) days. Max. volume of T-VEC administered at any dose is 4mL (Cohorts 1, 2, 5, and 6) or 8mL (Cohorts 3 \& 4) for any individual lesion or for all lesions combined. Part 2: Initial dose of T-VEC is 10\^6 PFU/mL followed by subsequent T-VEC doses at a concentration of 10\^8 PFU/mL. T-VEC volume is up to 8mL based on the size of the inejected lesions. NOTE: as of Protocol Amendment 6 \[dated 26 October 2021\], intrahepatic injections of talimogene laherparepvec and liver biopsies are no longer performed in this study.
Pembrolizumab
Pembrolizumab is a non-Amgen Investigational product that is manufactured by Merck. Pembrolizumab will be labeled, packaged, and distributed by Amgen (or designee) using Amgen (or designee) clinical study drug distribution procedures. Pembrolizumab is supplied as pembrolizumab 100 mg/4 mL vials (25 mg/mL) solution for IV infusion. The trial treatment will consist of a total dose of 200mg administered intravenously every 3 weeks (day 1 of each cycle) for up to 35 cycles.
Centre Hospitalier Universitaire Vaudois, Lausanne
Universite Catholique de Louvain Cliniques Universitaires Saint Luc, Brussels
Hopitaux Universitaires de Geneve, Geneva
Melanoma Institute Australia, North Sydney
Liverpool Hospital, Liverpool
Universitair Ziekenhuis Antwerpen, Edegem
Tasman Oncology Research, Southport
Landeskrankenhaus Salzburg, Salzburg
Universitaetsspital Zuerich, Zurich
Kantonsspital Winterthur, Winterthur
Universitair Ziekenhuis Gent, Ghent
Memorial Sloan Kettering Cancer Center, New York
Charite Universitätsmedizin Berlin, Charité Campus Virchow-Klinikum, Berlin
University of Pittsburgh, Pittsburgh
Georgetown-Howard University Center for Clinical Translational Science, Washington D.C.
Hospital General Universitario Gregorio Marañon, Madrid
Hospital Universitario Madrid Sanchinarro, Madrid
University of Louisville James Graham Brown Cancer Center, Louisville
Universitätsklinikum Bonn, Bonn
Washington University School of Medicine, Center for Advanced Medicine, St Louis
Universitätsklinikum Tübingen, Tübingen
Kreiskliniken Reutlingen - Klinikum am Steinenberg, Reutlingen
University of Texas MD Anderson Cancer Center, Houston
HonorHealth Research Institute, Scottsdale
University of California Los Angeles, Santa Monica
Rutgers Cancer Institute of New Jersey, New Brunswick
Uniwersyteckie Centrum Kliniczne, Gdansk
Cha Bundang Medical Center, Cha University, Seongnam-si, Gyeonggi-do
Seoul National University Hospital, Seoul
Severance Hospital Yonsei University Health System, Seoul
Hospital Universitari Vall d Hebron, Barcelona
Hospital Clinic i Provincial de Barcelona, Barcelona
Lead Sponsor
Merck Sharp & Dohme LLC
INDUSTRY
Amgen
INDUSTRY