Spots Global Cancer Trial Database for Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma
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Trial Identification
Brief Title: Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma
Official Title: A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable Stage IIIB to IVM1c Melanoma (MASTERKEY-265)
Study ID: NCT02263508
Conditions
Study Description
Brief Summary: The primary objectives of the Phase 1b part of the study are to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in adults with previously untreated, unresectable, stage IIIB to IVM1c melanoma. The primary objective of Phase 3 are to evaluate the efficacy of talimogene laherparepvec with pembrolizumab versus placebo with pembrolizumab, as assessed by progression-free survival (PFS) (response evaluation by blinded independent central review using modified Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) and overall survival (OS).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Birmingham, Alabama, United States
Research Site, Mobile, Alabama, United States
Research Site, Beverly Hills, California, United States
Research Site, Duarte, California, United States
Research Site, Encinitas, California, United States
Research Site, La Jolla, California, United States
Research Site, Los Angeles, California, United States
Research Site, Los Angeles, California, United States
Research Site, Riverside, California, United States
Research Site, San Francisco, California, United States
Research Site, San Francisco, California, United States
Research Site, Santa Monica, California, United States
Research Site, Miami Beach, Florida, United States
Research Site, Miami, Florida, United States
Research Site, Orlando, Florida, United States
Research Site, Atlanta, Georgia, United States
Research Site, Chicago, Illinois, United States
Research Site, Chicago, Illinois, United States
Research Site, Louisville, Kentucky, United States
Research Site, Baltimore, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, Detroit, Michigan, United States
Research Site, Fridley, Minnesota, United States
Research Site, Saint Louis, Missouri, United States
Research Site, Hackensack, New Jersey, United States
Research Site, Buffalo, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, Cincinnati, Ohio, United States
Research Site, Cleveland, Ohio, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Germantown, Tennessee, United States
Research Site, Knoxville, Tennessee, United States
Research Site, Nashville, Tennessee, United States
Research Site, Dallas, Texas, United States
Research Site, Murray, Utah, United States
Research Site, Salt Lake City, Utah, United States
Research Site, Seattle, Washington, United States
Research Site, North Sydney, New South Wales, Australia
Research Site, Waratah, New South Wales, Australia
Research Site, Wollongong, New South Wales, Australia
Research Site, Southport, Queensland, Australia
Research Site, Woolloongabba, Queensland, Australia
Research Site, Woodville South, South Australia, Australia
Research Site, Geelong, Victoria, Australia
Research Site, Heidelberg, Victoria, Australia
Research Site, Melbourne, Victoria, Australia
Research Site, Prahran, Victoria, Australia
Research Site, Murdoch, Western Australia, Australia
Research Site, Graz, , Austria
Research Site, Innsbruck, , Austria
Research Site, Salzburg, , Austria
Research Site, Wien, , Austria
Research Site, Bruxelles, , Belgium
Research Site, Liege, , Belgium
Research Site, Edmonton, Alberta, Canada
Research Site, Kingston, Ontario, Canada
Research Site, London, Ontario, Canada
Research Site, Ottawa, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Quebec, , Canada
Research Site, Brno, , Czechia
Research Site, Olomouc, , Czechia
Research Site, Ostrava-Poruba, , Czechia
Research Site, Praha 10, , Czechia
Research Site, Praha 2, , Czechia
Research Site, Praha 8, , Czechia
Research Site, Helsinki, , Finland
Research Site, Bordeaux Cedex, , France
Research Site, Grenoble Cedex 9, , France
Research Site, Lille, , France
Research Site, Lyon cedex 08, , France
Research Site, Marseille cedex 05, , France
Research Site, Nantes Cedex 1, , France
Research Site, Paris, , France
Research Site, Pierre Benite Cedex, , France
Research Site, Toulouse cedex 9, , France
Research Site, Vandoeuvre les Nancy, , France
Research Site, Berlin, , Germany
Research Site, Dresden, , Germany
Research Site, Erlangen, , Germany
Research Site, Essen, , Germany
Research Site, Hannover, , Germany
Research Site, Heidelberg, , Germany
Research Site, Kiel, , Germany
Research Site, Leipzig, , Germany
Research Site, Mainz, , Germany
Research Site, Mannheim, , Germany
Research Site, München, , Germany
Research Site, Regensburg, , Germany
Research Site, Tübingen, , Germany
Research Site, Würzburg, , Germany
Research Site, Athens, , Greece
Research Site, Athens, , Greece
Research Site, Heraklion - Crete, , Greece
Research Site, Ioannina, , Greece
Research Site, Thessaloniki, , Greece
Research Site, Budapest, , Hungary
Research Site, Pecs, , Hungary
Research Site, Szeged, , Hungary
Research Site, Bergamo, , Italy
Research Site, Brescia, , Italy
Research Site, Meldola FC, , Italy
Research Site, Milano, , Italy
Research Site, Milano, , Italy
Research Site, Siena, , Italy
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Amsterdam, , Netherlands
Research Site, Amsterdam, , Netherlands
Research Site, Groningen, , Netherlands
Research Site, Nijmegen, , Netherlands
Research Site, Bielsko-Biala, , Poland
Research Site, Bydgoszcz, , Poland
Research Site, Gdansk, , Poland
Research Site, Konin, , Poland
Research Site, Krakow, , Poland
Research Site, Poznan, , Poland
Research Site, Poznan, , Poland
Research Site, Szczecin, , Poland
Research Site, Warszawa, , Poland
Research Site, Wroclaw, , Poland
Research Site, Almada, , Portugal
Research Site, Lisboa, , Portugal
Research Site, Lisboa, , Portugal
Research Site, Porto, , Portugal
Research Site, Moscow, , Russian Federation
Research Site, Saint-Petersburg, , Russian Federation
Research Site, Groenkloof, Gauteng, South Africa
Research Site, Johannesburg, Gauteng, South Africa
Research Site, Parktown, Gauteng, South Africa
Research Site, Kraaifontein, , South Africa
Research Site, Pretoria, , South Africa
Research Site, Pretoria, , South Africa
Research Site, Badalona, Cataluña, Spain
Research Site, Barcelona, Cataluña, Spain
Research Site, Valencia, Comunidad Valenciana, Spain
Research Site, Pamplona, Navarra, Spain
Research Site, San Sebastian, País Vasco, Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Bellinzona, , Switzerland
Research Site, Bern, , Switzerland
Research Site, Geneva 14, , Switzerland
Research Site, Lausanne, , Switzerland
Research Site, Zürich, , Switzerland
Research Site, Birmingham, , United Kingdom
Research Site, Guildford, , United Kingdom
Research Site, Leeds, , United Kingdom
Research Site, Leicester, , United Kingdom
Research Site, London, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Oxford, , United Kingdom
Research Site, Preston, , United Kingdom
Research Site, Southampton, , United Kingdom
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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