Spots Global Cancer Trial Database for Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).
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Trial Identification
Brief Title: Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).
Official Title: Phase 2 Study of Talimogene Laherparepvec in Combination With Pembrolizumab in Subjects With Unresectable/Metastatic Stage IIIB-IVM1d Melanoma Who Have Progressed on Prior Anti PD-1 Based Therapy
Study ID: NCT04068181
Conditions
Study Description
Brief Summary: This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior anti-programmed cell death protein (anti-PD-1) therapy in unresectable/metastatic melanoma (stage IIIB-IVM1d) or prior anti-PD-1 therapy in the adjuvant setting. Subjects will be treated with talimogene laherparepvec and pembrolizumab until confirmed complete response, disappearance of all injectable lesions, documented confirmed disease progression per modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST), intolerance of study treatment, or 102 weeks from the first dose of talimogene laherparepvec and/or pembrolizumab, whichever occurs first.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sansum Clinic, Santa Barbara, California, United States
Medical Oncology Hematology Consultants Helen F Graham Cancer Center, Newark, Delaware, United States
University of Florida Health Cancer Center at Orlando Health, Orlando, Florida, United States
University of Louisville James Graham Brown Cancer Center, Louisville, Kentucky, United States
Allina Health Systems dba Virginia Piper Cancer Institute, Fridley, Minnesota, United States
New York Oncology Hematology, PC, Albany, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
Texas Oncology Austin Central, Austin, Texas, United States
Baylor Scott and White Research Institute, Dallas, Texas, United States
United States Oncology Regulatory Affairs Corporate Office, The Woodlands, Texas, United States
Melanoma Institute Australia, North Sydney, New South Wales, Australia
Tasman Oncology Research, Southport, Queensland, Australia
The Queen Elizabeth Hospital, Woodville South, South Australia, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
CHU de Quebec-Universite Laval, Quebec, , Canada
Centre Hospitalier Universitaire de Bordeaux - Hôpital Saint André, Bordeaux, , France
Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon, Grenoble Cedex 9, , France
Centre Hospitalier Universitaire de Nantes, Hôpital Hôtel Dieu, Nantes Cedex 1, , France
Hopital Saint Louis, Paris, , France
Centre Hospitalier Lyon Sud, Pierre Benite Cedex, , France
Gustave Roussy, Villejuif, , France
Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden, Dresden, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitätsklinikum Regensburg, Regensburg, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
General Hospital of Athens Laiko, Athens, , Greece
University Hospital of Ioannina, Ioannina, , Greece
Bioclinic of Thessaloniki, Thessaloniki, , Greece
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, , Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola FC, , Italy
IRCCS Istituto Europeo di Oncologia, Milano, , Italy
Nederlands Kanker Instituut, Antoni van Leeuwenhoekziekenhuis, Amsterdam, , Netherlands
Erasmus Medisch Centrum, Rotterdam, , Netherlands
Uniwersyteckie Centrum Kliniczne Centrum Medycyny Nieinwazyjnej, Gdansk, , Poland
Szpital Kliniczny im Heliodora Swiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Pozn, Poznan, , Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€" Panstwowy Instytut Badawczy, Warszawa, , Poland
Hospital Clinico Universitario Virgen de la Victoria, Malaga, AndalucÃ-a, Spain
Onkologikoa, San Sebastian, PaÃ-s Vasco, Spain
Hospital Universitari Vall d Hebron, Barcelona, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Madrid Sanchinarro, Madrid, , Spain
Guys Hospital, London, , United Kingdom
Royal Marsden Hospital, London, , United Kingdom
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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