Spots Global Cancer Trial Database for Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913)
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Trial Identification
Brief Title: Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913)
Official Title: A Phase 3 Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) as First Line Therapy in Participants With Advanced Merkel Cell Carcinoma (KEYNOTE-913)
Study ID: NCT03783078
Conditions
Interventions
Study Description
Brief Summary: This is a single-arm, open-label, multicenter, efficacy, and safety study of pembrolizumab in adult and pediatric participants with previously untreated advanced Merkel Cell Carcinoma (MCC). The primary objective of the trial is to assess the objective response rate, as assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, following administration of pembrolizumab.
Detailed Description:
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0006), New York, New York, United States
Icahn School of Medicine at Mount Sinai ( Site 0004), New York, New York, United States
Melanoma Institute Australia ( Site 0400), North Sydney, New South Wales, Australia
Calvary Mater Newcastle ( Site 0402), Waratah, New South Wales, Australia
Moncton Hospital - Horizon Health Network ( Site 0055), Moncton, New Brunswick, Canada
Princess Margaret Cancer Centre ( Site 0051), Toronto, Ontario, Canada
Hopital de la Cote de Nacre - Caen ( Site 0204), Caen, Calvados, France
CHU de Bordeaux- Hopital Saint Andre ( Site 0203), Bordeaux, Gironde, France
Hopital Ambroise Pare Boulogne ( Site 0201), Boulogne-Billancourt, Hauts-de-Seine, France
C.H.R.U. de Tours. Hopital Trousseau ( Site 0202), Chambray Les Tours, Indre-et-Loire, France
CHRU Lille - Hopital Claude Huriez ( Site 0200), Lille, Nord, France
Azienda Ospedaliera Universitaria Senese ( Site 0224), Siena, Toscana, Italy
IEO Istituto Europeo di Oncologia ( Site 0223), Milano, , Italy
Istituto Nazionale Tumori Fondazione Pascale ( Site 0222), Napoli, , Italy
Istituto Oncologico Veneto ( Site 0221), Padova, , Italy
Auckland City Hospital ( Site 0427), Auckland, , New Zealand
Hospital General Universitario de Valencia ( Site 0262), Valencia, Valenciana, Comunitat, Spain
Hospital Universitari Vall d Hebron ( Site 0264), Barcelona, , Spain
Hospital Clinic de Barcelona ( Site 0261), Barcelona, , Spain
Hospital Universitario La Paz ( Site 0263), Madrid, , Spain
Karolinska Universitetssjukhuset Solna ( Site 0281), Solna, Stockholms Lan, Sweden
Sahlgrenska Universitetssjukhuset ( Site 0282), Goeteborg, Vastra Gotalands Lan, Sweden
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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