Spots Global Cancer Trial Database for Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma
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Trial Identification
Brief Title: Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma
Official Title: A Phase 2, Multicenter, Open-label, Single-arm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma Treated With Talimogene Laherparepvec
Study ID: NCT02366195
Conditions
Interventions
Study Description
Brief Summary: The study is a phase 2, multi centered, single arm study designed to evaluate the correlation between cluster of differentiation 8-positive (CD8+) cell density and objective response rate in adults with unresected stage IIIB to IVM1c melanoma. This study will also evaluate the safety and tolerability profile of talimogene laherparepvec.
Detailed Description: The study will explore the hypothesis that intratumoral CD8+ cell density at baseline correlates with objective response rate in adults with unresected stage IIIB to IVMIc melanoma treated with talimogene laherparepvec.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Salt Lake City, Utah, United States
Research Site, Salzburg, , Austria
Research Site, Wien, , Austria
Research Site, Bruxelles, , Belgium
Research Site, Bruxelles, , Belgium
Research Site, Liege, , Belgium
Research Site, Boulogne Billancourt, , France
Research Site, Marseille cedex 05, , France
Research Site, Nantes Cedex 1, , France
Research Site, Paris, , France
Research Site, Poitiers Cedex, , France
Research Site, Essen, , Germany
Research Site, Frankfurt am Main, , Germany
Research Site, Hannover, , Germany
Research Site, Heidelberg, , Germany
Research Site, Athens, , Greece
Research Site, Athens, , Greece
Research Site, Heraklion - Crete, , Greece
Research Site, Patra, , Greece
Research Site, Thessaloniki, , Greece
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Debrecen, , Hungary
Research Site, Pecs, , Hungary
Research Site, Szeged, , Hungary
Research Site, Bergamo, , Italy
Research Site, Milano, , Italy
Research Site, Siena, , Italy
Research Site, Amsterdam, , Netherlands
Research Site, Groningen, , Netherlands
Research Site, Konin, , Poland
Research Site, Warszawa, , Poland
Research Site, Moscow, , Russian Federation
Research Site, Saint-Petersburg, , Russian Federation
Research Site, Badalona, Cataluña, Spain
Research Site, Barcelona, Cataluña, Spain
Research Site, Valencia, Comunidad Valenciana, Spain
Research Site, San Sebastian, País Vasco, Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, London, , United Kingdom
Research Site, Wirral, , United Kingdom
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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