Phase 2 open-label, multicenter, single-arm study of cemiplimab in patients with locally advanced basal cell carcinoma after hedgehog inhibitor therapy: Extended follow-up - 11/01/24
Doi : 10.1016/j.jaad.2023.08.111
Alexander J. Stratigos, MD, PhD a, ⁎ 
, Aleksandar Sekulic, MD b, Ketty Peris, MD c, Oliver Bechter, MD d, Sorilla Prey, MD e, Karl D. Lewis, MD f, Nicole Basset-Seguin, PhD g, Anne Lynn S. Chang, MD h, Stéphane Dalle, MD i, Almudena Fernández Orland, MD j, Lisa Licitra, MD k, Caroline Robert, PhD l, Claas Ulrich, MD m, Axel Hauschild, MD n, Michael R. Migden, MD o, Reinhard Dummer, MD p, Suk-Young Yoo, PhD q, Emmanuel Okoye, MBBS, MPH q, Ioannis Bassukas, MD r, Carmen Loquai, MD s, Vincenzo De Giorgi, MD t, Zeynep Eroglu, MD u, Ralf Gutzmer, MD v, Jens Ulrich, MD w, Susana Puig, MD x, Timothy J. Inocencio, PharmD, PhD q, Chieh-I Chen, MPH q, Patrick R. LaFontaine, PharmD y, Frank Seebach, MD q, Israel Lowy, MD, PhD q, Matthew G. Fury, MD, PhD q
, Aleksandar Sekulic, MD b, Ketty Peris, MD c, Oliver Bechter, MD d, Sorilla Prey, MD e, Karl D. Lewis, MD f, Nicole Basset-Seguin, PhD g, Anne Lynn S. Chang, MD h, Stéphane Dalle, MD i, Almudena Fernández Orland, MD j, Lisa Licitra, MD k, Caroline Robert, PhD l, Claas Ulrich, MD m, Axel Hauschild, MD n, Michael R. Migden, MD o, Reinhard Dummer, MD p, Suk-Young Yoo, PhD q, Emmanuel Okoye, MBBS, MPH q, Ioannis Bassukas, MD r, Carmen Loquai, MD s, Vincenzo De Giorgi, MD t, Zeynep Eroglu, MD u, Ralf Gutzmer, MD v, Jens Ulrich, MD w, Susana Puig, MD x, Timothy J. Inocencio, PharmD, PhD q, Chieh-I Chen, MPH q, Patrick R. LaFontaine, PharmD y, Frank Seebach, MD q, Israel Lowy, MD, PhD q, Matthew G. Fury, MD, PhD q a Department of Dermatology-Venereology, Andreas Sygros Hospital-National and Kapodistrian University of Athens, Athens, Greece
b Department of Dermatology, Arizona Mayo Clinic, Scottsdale, Arizona
c Dipartimento di Scienze Mediche e Chirurgiche, UOC di Dermatologia, Fondazione Policlinico Universitario A. Gemelli - IRCCS, Rome, Italy
d Department of General Medical Oncology, University Hospitals, Leuven, Belgium
e Department of Dermatology, Bordeaux University Hospital, Bordeaux, France
f School of Medicine, University of Colorado, Aurora, Colorado
g Department of Dermatology, Hôpital Saint-Louis, Paris, France
h Department of Dermatology, Stanford University School of Medicine, Stanford, California
i Department of Dermatology, Centre Hospitalier Lyon-Sud, Lyon, France
j Department of Dermatology, Hospital Universitario Virgen Macarena, Seville, Spain
k Medical Oncology Head and Neck Cancer Department, Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, Milan, Italy
l Dermatology Unit, Gustave Roussy Cancer Center and Paris-Saclay University, Villejuif, France
m Skin Cancer Centre, Charite-Universitätsmedizin Berlin, Berlin, Germany
n Department of Dermatology, University of Kiel, Kiel, Germany
o Departments of Dermatology and Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston, Texas
p Department of Dermatology, University Hospital Zurich, Zurich, Switzerland
q Regeneron Pharmaceuticals, Inc, Tarrytown, New York
r Faculty of Medicine, Department of Skin and Venereal Diseases, School of Health Sciences, University of Ioannina, Ioannina, Greece
s Department of Dermatology, University Medical Center Mainz, Mainz, Germany
t Departments of Dermatology, Human Pathology, and Oncology, University of Florence, Florence, Italy
u Department of Cutaneous Oncology, Moffitt Cancer Center, Tampa, Florida
v Johannes Wesling Medical Center, Ruhr University Bochum, Minden, Germany
w Academic Teaching Hospital of the University Otto von Guericke Magdeburg, Quedlinburg, Germany
x Dermatology Department, Hospital Clinic of Barcelona, University of Barcelona, Barcelona, Spain
y Sanofi, Cambridge, Massachusetts
∗Correspondence to: Alexander J. Stratigos, MD, PhD, Department of Dermatology-Venereology, Andreas Sygros Hospital-National and Kapodistrian University of Athens, 5 Ionos Dragoumi St, Athens, 16121, GreeceDepartment of Dermatology-VenereologyAndreas Sygros Hospital-National and Kapodistrian University of Athens5 Ionos Dragoumi StAthens16121Greece
Key words : cemiplimab, clinical trial, hedgehog inhibitor, immune checkpoint inhibitor, locally advanced basal cell carcinoma, phase 2, quality of life
| Funding sources: This study was funded by Regeneron Pharmaceuticals, Inc, and Sanofi. |
|
| Patient consent: All patients provided written informed consent. |
|
| IRB approval status: The study protocol and all amendments were approved by the institutional review board/ethics committee at each participating study site. |
© 2023
American Academy of Dermatology, Inc.. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
Vol 90 - N° 2
P. 414-418 - febbraio 2024 Ritorno al numero
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