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Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
Sponsor: Replimune Inc.
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
231
Start Date
2019-10-08
Completion Date
2025-09
Last Updated
2025-01-27
Healthy Volunteers
No
Conditions
Interventions
Cemiplimab
Cemiplimab administered intravenously
RP1
RP1 administered intratumorally
Locations (56)
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
Besançon, 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
Gdansk, Poland
Narodowy Instytut Onkologii; Panstwowy Instytut Badawczy Oddzial w Krakowie
Krakow, Poland
Narodowy Instytut Onkologii; Panstwowy Instytut Badawczy
Warsaw, Poland
Klinika Dermatologii, Wenerologii i Alergologii, USK im J. Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 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