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Brief Title: PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
Official Title: A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1, in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
Study ID: NCT03132636
Brief Summary: The primary objective is to estimate the objective response rate (ORR) for metastatic Basal Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when treated with cemiplimab as a monotherapy
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The University of Arizona Cancer Centre at Dignity Health, Phoenix, Arizona, United States
Mayo Clinic Arizona - Mayo Clinic Hospital, Phoenix, Arizona, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine, Redwood City, California, United States
UCSF Helen Dillion Family Cancer Care Center, San Francisco, California, United States
University of Colorado Hospital, Anschutz Outpatient Pavilion, Denver, Colorado, United States
Mount Sinai Comprehensive Cancer Center, Miami, Florida, United States
H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Northwestern Medical Faculty Foundation, Chicago, Illinois, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute (DFCI), Boston, Massachusetts, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Atlantic Health System / Morristown Medical Center, Morristown, New Jersey, United States
Overlook Medical Center, Summit, New Jersey, United States
New York University School Of Medicine, Kaplan Comprehensive Cancer Center, New York, New York, United States
Mount Sinai Hospital, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
James Cancer Hospital and Solove Research Institute, Columbus, Ohio, United States
Penn State Hershey Medical Center, Hershey, Pennsylvania, United States
Clinical Research Center of the Carolinas, Charleston, South Carolina, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
LKH - Universitaetsklinikum Graz, Graz, Steiermark, Austria
Medizinische Universitaet Innsbruck, Universitaetsklinik fuer Dermatologie, Venerologie und Allergologie, Innsbruck, , Austria
Cliniques Universitaires Saint-Luc, Bruxelles, , Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, , Belgium
Cross Cancer Institute, Edmonton, Alberta, Canada
Odette Cancer Center-Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
University Health Network, Toronto, Ontario, Canada
London Regional Cancer Program, London Hsc, Toronto, Ontario, Canada
CHU de Dijon - Hopital du Bocage, Dijon, Cedex, France
Hopital Saint Louis, Paris, Europe, France
Centre Hospitalier Lyon-Sud -Hospices Civils de Lyon Groupement Hospitalier Sud, Pierre Benite Cedex, Paris, France
Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-André - Hôpital Saint-André, Bordeaux, , France
Hopital Ambroise Pare, Boulogne Billancourt, , France
Centre Hospitalier Universitaire de Grenoble, La Tronche, , France
Hopital Huriez - CHRU de Lille, Lille Cedex, , France
Centre Leon-Berard (CLB), Lyon, , France
CHU Hotel Dieu, Nantes, , France
Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle, Rouen cedex, , France
Institut Claudius Regaud, Toulouse Cedex, , France
Institut Gustave Roussy, Villejuif Cedex, , France
University Hospital Frankfurt, Frankfurt, Hessen/Germany, Germany
Hauttumorcentrum der Charite (HTCC)-Charite Universitatsmedizin Berlin, Berlin, , Germany
Elbekliniken Buxtehude, Buxtehude, , Germany
University Hospital Dresden, Dresden, , Germany
Universitaetsklinik Essen, Essen, , Germany
SRH Wald-Kliniken Gera GmbH, Gera, , Germany
Hannover Medical School, Hannover, , Germany
NCT Dermatoonkologie, Heidelberg, , Germany
University of Kiel, Kiel, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz, , Germany
Klinik Fur Dermatologie Und Allergollogie, Quedlinburg, , Germany
University Hospital Tubingen, Tübingen, , Germany
National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine, Athens, , Greece
National and Kapodistrian University of Athens - School of Health Sciences, Athens, , Greece
Andreas Sygros Hosptial-University of Athen, Athens, , Greece
University General Hospital of Ioannina - Dermatology and Venereology Department, Ioánnina, , Greece
Policlinico S.Orsola-Malpighi U.O. Dermatologia - University of Bologna, Bologna, Bo, Italy
Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia, Brescia, Province Of Brescia, Italy
U.O.Dermatologia Azienda Sanitaria Firenze Universita' Firenze, Firenze, , Italy
University L'Aquila, L'Aquila, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
U.O.S.C Di Oncologia Medica E Terapie Innovative, Napoli, , Italy
Catholic University of the S.Heart, Roma, , Italy
Catalan Institute of Oncology Badalona, Badalona, , Spain
Hospital Clinic I Provincialde Barcelona, Barcelona, , Spain
Hospital Universitario de Torrejon, Madrid, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
University Hospital Zurich Usz, Zürich, , Switzerland
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR