Spots Global Cancer Trial Database for Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
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Trial Identification
Brief Title: Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
Official Title: A Randomized, Controlled, Open-Label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination With RP1 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Study ID: NCT04050436
Study Description
Brief Summary: To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) and complete response rate (CRR) according to blinded independent review.
Detailed Description: RP1 is a selectively replication competent herpes simplex virus type 1(HSV-1). This is a Phase 1/2, open-label, multicenter repeat-dosing study of RP1 alone and in combination with nivolumab in patients with advanced malignancies, and contains both single agent dose escalation, dose expansion to include nivolumab, and the combination in multiple Phase 2 cohorts in individual tumor types.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California San Diego, La Jolla, California, United States
University of California Los Angeles, Los Angeles, California, United States
Stanford University, Stanford, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
University of Miami Health System, Miami, Florida, United States
Orlando Health UF Health Cancer Center, Orlando, Florida, United States
Moffitt McKinley Outpatient Center, Tampa, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
John Theurer Cancer Center at Hackensack Univeristy Medical Center, Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University Of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Prisma Health Cancer Institute, Greenville, South Carolina, United States
MD Anderson Cancer Center, Houston, Texas, United States
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
Cancer Care Wollongong Pty Limited, Wollongong, New South Wales, Australia
Tasman Oncology Research Ltd, Southport, Queensland, Australia
Monash Medical Centre, Clayton, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Multiprofile Hospital for Active Treatment - Uni Hospital" OOD Department of Medical Oncology, Panagyurishte, , Bulgaria
"Complex Oncology Center - Plovdiv" EOOD Department of Medical Oncology and Cutaneous Cancer Diseases ", Plovdiv, , Bulgaria
Sunnybrook Health Science Centre, Toronto, Ontario, Canada
CHU Besancon - Hopital Jean Minjoz, Besancon, , France
CHU Dijon Hopital F. Mitterrand Service de Dermatologie - UMAC, Dijon, , France
CHU de Grenoble - Hopital A Michallon, La Tronche, , France
CHRU de Lille, Lille, , France
Centre Léon Bérard, Lyon, , France
Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone, Marseille, , France
CHU Nice - Hopital de l'Archet 2, Nice, , France
Hospital Saint Louis, Paris, , France
Hospices Civils de Lyon, Pierre-Bénite, , France
Institut Gustave Roussy, Villejuif, , France
Charite Universitatsmedizin Berlin, Berlin, , Germany
Universitatsklinikum Essen, Essen, , Germany
Universitätsklinikum Eppendorf, Hamburg, , Germany
Universitatsklinikum Heidelberg: National Centre for Tumour Diseases (NCT), Heidelberg, , Germany
University Hospital Munchen (LMU), München, , Germany
Universitatsklinikum Tubingen Zentrum fur Dermatoonkologie, Tübingen, , Germany
Hippocratio General Hospital of Athens, Athens, , Greece
Attiko University Hospital, Athens, , Greece
Andreas Syggros Hospital, Athens, , Greece
General Hospital of Athens "Laiko", 1st Department of Medicine, University of Athens Medical School, Athens, , Greece
Istituto Tumori "Giovanni Paolo II" IRCCS, Bari, , Italy
Uniwersyteckie Centrum Kliniczne; Centrum Leczenia Czerniaka w Gdańsku, Gdańsk, , Poland
Narodowy Instytut Onkologii; Panstwowy Instytut Badawczy Oddzial w Krakowie, Kraków, , Poland
Narodowy Instytut Onkologii; Panstwowy Instytut Badawczy, Warsaw, , Poland
Klinika Dermatologii, Wenerologii i Alergologii, USK im J. Mikulicza-Radeckiego we Wroclawiu, Wrocław, , Poland
Hospital Clinic Barcelona, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario Virgen de la Arrixaca, Murcia, , Spain
Clinica Universitaria de Navarra, Pamplona, , Spain
Hospital General Universitario De Valencia, Valencia, , Spain
Contact Details
Name: Sumera Raoof, MD
Affiliation: Lead Medical Monitor
Role: STUDY_DIRECTOR
Name: Jeannie Hou, MD
Affiliation: Secondary Medical Monitor
Role: STUDY_DIRECTOR
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