Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
NCT ID: NCT04050436
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
231 participants
INTERVENTIONAL
2019-10-08
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cemiplimab in combination with RP1
Cemiplimab administered intravenously every 3 weeks in combination with RP1 administered as an intratumoral injection every 3 weeks
Cemiplimab
Cemiplimab administered intravenously
RP1
RP1 administered intratumorally
Cemiplimab
Cemiplimab administered intravenously as a single therapy every 3 weeks
Cemiplimab
Cemiplimab administered intravenously
Interventions
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Cemiplimab
Cemiplimab administered intravenously
RP1
RP1 administered intratumorally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with locally advanced disease who are not suitable candidates for surgical or radiological treatment of lesions or have refused those treatments
* At least 1 lesion that is measurable and injectable by study criteria
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG PS 2 at baseline may be allowed to enroll if PS 2 status is only related to the CSCC disease under study
* Anticipated life expectancy \>12 weeks
* All patients must consent to provide archived or newly obtained tumor material for central pathology review for confirmation of diagnosis of CSCC.
Exclusion Criteria
* Patients with active significant herpetic infections or prior complications of HSV-1 infection (e.g. herpetic keratitis or encephalitis)
* Patients who require intermittent or chronic use of systemic (oral or intravenous) anti-virals with known anti-herpetic activity (e.g. acyclovir)
* Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
* Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
* Prior treatment with other immune modulating agents other than as adjuvant or neoadjuvant therapy within 3 years.
* Untreated brain metastasis(es) that may be considered active.
* Acute or chronic active hepatitis B or known history of hepatitis B or hepatitis C or human immunodeficiency virus (HIV) infection
* History of ILD/pneumonitis within the last 5 years or a history of ILD/pneumonitis requiring treatment with systemic steroids.
* Any major or surgical procedure ≤ 28 days before randomization
* Administration of live vaccines ≤ 28 days before randomization
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Replimune Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Moran Mishal, MD
Role: STUDY_DIRECTOR
Lead Medical Monitor
Jeannie Hou, MD
Role: STUDY_DIRECTOR
Secondary Medical Monitor
Locations
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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
Countries
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Other Identifiers
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RPL-002-18
Identifier Type: -
Identifier Source: org_study_id
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