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
NCT ID: NCT03132636
Last Updated: 2025-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
138 participants
INTERVENTIONAL
2017-06-29
2023-04-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1- metastatic BCC
Administration of cemiplimab in accordance with protocol dosing regimen
cemiplimab
Regimen as per protocol
Group 2 - unresectable locally advanced BCC
Administration of cemiplimab in accordance with protocol dosing regimen
cemiplimab
Regimen as per protocol
Interventions
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cemiplimab
Regimen as per protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Progression of disease on hedgehog inhibitor (HHI) therapy or intolerance of prior HHI therapy
* At least 1 measurable lesion
* ≥18 years of age
* Hepatic function, renal function, bone marrow function in defined lab-value-ranges
* Anticipated life expectancy \>12 weeks
* Consent to provide archived tumor biopsy material (all patients)
* Group 2: consent to undergo research biopsies
* Group 2: must not be a candidate for radiation therapy or surgery
* Comply with study procedures and site visits
* Sign Subject Information Sheet and Informed Consent Form
Exclusion Criteria
* Prior treatment with specific pathway-blockers (PD-1/PD-L1)
* Prior treatment with immune-modulating agents within 28 days before cemiplimab
* Untreated brain metastasis that may be considered active
* Immunosuppressive corticosteroid doses (\>10mg prednisone) within 28 days prior to treatment with cemiplimab
* Active infections requiring therapy, including HIV, hepatitis
* Pneumonitis within the last 5 years
* Cancer treatment other than radiation therapy, including investigational or standard of care, within 30 days prior to treatment with cemiplimab
* Documented allergic reactions or similar to antibody treatments
* Concurrent malignancies other than BCC, other than those with negligible risk of metastases or death
* Any acute or chronic psychiatric problems
* Having received a solid organ transplantation
* Inability to undergo contrast radiological assessments
* Breastfeeding, pregnant, women of childbearing potential not using contraception
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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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
St 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, Styria, Austria
Medizinische Universitaet Innsbruck, Universitaetsklinik fuer Dermatologie, Venerologie und Allergologie
Innsbruck, , Austria
Cliniques Universitaires Saint-Luc
Brussels, , 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-Bénite, 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, , France
Centre Leon-Berard (CLB)
Lyon, , France
CHU Hotel Dieu
Nantes, , France
Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
Rouen, , France
Institut Claudius Regaud
Toulouse, , France
Institut Gustave Roussy
Villejuif, , 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
Hanover, , 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
Ioannina, , 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
Florence, , Italy
University L'Aquila
L’Aquila, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , 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
Seville, , Spain
University Hospital Zurich Usz
Zurich, , Switzerland
Countries
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References
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Stratigos AJ, Chen CI, Ivanescu C, Lewis KD, Peris K, Bechter O, Harnett J, Mastey V, Reaney M, Daskalopoulou C, LaFontaine PR, Konidaris G, Bury D, Yoo SY, Mohan K, Coates E, Bowler T, Fury MG, Sekulic A. Quality of life in cemiplimab-treated patients with locally advanced basal cell carcinoma in a Phase II clinical trial. Future Oncol. 2024;20(30):2249-2258. doi: 10.1080/14796694.2024.2358670. Epub 2024 Jul 29.
Lewis KD, Peris K, Sekulic A, Stratigos AJ, Dunn L, Eroglu Z, Chang ALS, Migden MR, Yoo SY, Mohan K, Coates E, Okoye E, Bowler T, Baurain JF, Bechter O, Hauschild A, Butler MO, Hernandez-Aya L, Licitra L, Neves RI, Ruiz ES, Seebach F, Lowy I, Goncalves P, Fury MG. Final analysis of phase II results with cemiplimab in metastatic basal cell carcinoma after hedgehog pathway inhibitors. Ann Oncol. 2024 Feb;35(2):221-228. doi: 10.1016/j.annonc.2023.10.123. Epub 2023 Dec 9.
Stratigos AJ, Sekulic A, Peris K, Bechter O, Prey S, Lewis KD, Basset-Seguin N, Chang ALS, Dalle S, Fernandez Orland A, Licitra L, Robert C, Ulrich C, Hauschild A, Migden MR, Dummer R, Yoo SY, Okoye E, Bassukas I, Loquai C, De Giorgi V, Eroglu Z, Gutzmer R, Ulrich J, Puig S, Inocencio TJ, Chen CI, LaFontaine PR, Seebach F, Lowy I, Fury MG. 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. J Am Acad Dermatol. 2024 Feb;90(2):414-418. doi: 10.1016/j.jaad.2023.08.111. Epub 2023 Oct 14. No abstract available.
Stratigos AJ, Sekulic A, Peris K, Bechter O, Prey S, Kaatz M, Lewis KD, Basset-Seguin N, Chang ALS, Dalle S, Orland AF, Licitra L, Robert C, Ulrich C, Hauschild A, Migden MR, Dummer R, Li S, Yoo SY, Mohan K, Coates E, Jankovic V, Fiaschi N, Okoye E, Bassukas ID, Loquai C, De Giorgi V, Eroglu Z, Gutzmer R, Ulrich J, Puig S, Seebach F, Thurston G, Weinreich DM, Yancopoulos GD, Lowy I, Bowler T, Fury MG. Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multi-centre, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):848-857. doi: 10.1016/S1470-2045(21)00126-1. Epub 2021 May 14.
Li R, Lee G, Huang M, El-Sherief A. Rare basal cell metastasis of a basal-squamous skin collision tumour to the lung and axillary lymph node. BMJ Case Rep. 2019 Oct 3;12(10):e231487. doi: 10.1136/bcr-2019-231487.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Summary is available on TrialSummaries.com
Other Identifiers
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2016-003122-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R2810-ONC-1620
Identifier Type: -
Identifier Source: org_study_id
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