Clinical trial • Phase III • Oncology
CEMIPLIMAB for Cutaneous squamous cell carcinoma
Phase III trial of CEMIPLIMAB for Cutaneous squamous cell carcinoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Cutaneous squamous cell carcinoma
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 21-05-2024
- First CTIS Authorization Date
- 26-06-2024
Trial design
Randomised, libtayo (cemiplimab) 350 mg concentrate for solution for infusion; matching placebo with r2810 — dosing schedule not specified in the provided data.-controlled Phase III trial across 43 sites in France, Italy, Germany and others.
- Randomised
- Yes
- Comparator
- LIBTAYO (cemiplimab) 350 mg concentrate for solution for infusion; matching Placebo with R2810 — dosing schedule not specified in the provided data.
- Target Sample Size
- 279
Eligibility
Recruits 279 Vulnerable population selected (isVulnerablePopulationSelected = true). Country-specific subject information and informed consent forms are listed in the trial documents (multiple L1_SIS-ICF documents for different countries/languages). No explicit text about assent or specific consent-by-proxy procedures for vulnerable subgroups is available in the provided CTIS JSON..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Country-specific subject information and informed consent forms are listed in the trial documents (multiple L1_SIS-ICF documents for different countries/languages). No explicit text about assent or specific consent-by-proxy procedures for vulnerable subgroups is available in the provided CTIS JSON.
Inclusion criteria
- {"criterion_text":"- Patient with resection of pathologically confirmed CSCC (primary CSCC lesion only, or primary CSCC with nodal involvement, or CSCC nodal metastasis with known primary CSCC lesion previously treated within the draining lymph node echelon), with macroscopic gross resection of all disease"}
- {"criterion_text":"- High risk CSCC"}
- {"criterion_text":"- Completion of curative intent post-operative radiation therapy (RT) within 2 to 10 weeks of randomization"}
- {"criterion_text":"- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1"}
- {"criterion_text":"- Adequate hepatic, renal, and bone marrow function as defined in the protocol"}
Exclusion criteria
- {"criterion_text":"- Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol Concurrent malignancy other than localized CSCC and/or history of malignancy other than localized CSCC within 3 years of date of randomization as defined in the protocol"}
- {"criterion_text":"- Patients with hematologic malignancies (note: patients with chronic lymphocytic leukemia (CLL) are not excluded if they have not required systemic therapy for CLL within 6 months of enrollment)"}
- {"criterion_text":"- Patients with history of distantly metastatic CSCC (visceral or distant nodal), unless the disease-free interval is at least 3 years (regional nodal involvement of disease in draining lymph node basin that was resected and radiated prior to enrollment will not be exclusionary)"}
- {"criterion_text":"- Ongoing or recent (within 5 years of randomization date) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment."}
- {"criterion_text":"- Has had prior systemic anti-cancer immunotherapy for CSCC"}
- {"criterion_text":"- Note: Other protocol defined Inclusion/Exclusion criteria apply"}
Endpoints
Primary endpoints
- {"endpoint_text":"- DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause.","definition_or_measurement_approach":"Defined as time from randomization to the first documented disease recurrence (local, regional and/or distant) or death from any cause (time-to-event)."}
Secondary endpoints
- {"endpoint_text":"- Overall survival (OS), defined as time from randomization to the date of death.","definition_or_measurement_approach":"Defined as time from randomization to date of death (time-to-event)."}
- {"endpoint_text":"- FFLRR defined as time from randomization to the date of first locoregional recurrence (LRR).","definition_or_measurement_approach":"Defined as time from randomization to date of first locoregional recurrence (time-to-event)."}
- {"endpoint_text":"- Freedom from distant recurrence (FFDR), defined as time from randomization to the date of first distant recurrence (DR). Patients who died without a preceding DR will be censored on the date of death.","definition_or_measurement_approach":"Defined as time from randomization to date of first distant recurrence; patients who die without prior distant recurrence are censored at death (time-to-event with censoring rules specified)."}
- {"endpoint_text":"- Cumulative occurrence of second primary cutaneous squamous cell carcinoma tumor (SPTs) for each patient from randomization to occurrence of first primary endpoint event or end of study.","definition_or_measurement_approach":"Cumulative incidence of second primary CSCC from randomization until the first primary endpoint event or end of study."}
- {"endpoint_text":"- Safety, as measured by the incidence and severity of treatment-emergent adverse events (TEAE), deaths, and laboratory abnormalities.","definition_or_measurement_approach":"Safety assessed by incidence and severity of TEAEs, deaths, and laboratory abnormalities (standard safety reporting)."}
- {"endpoint_text":"- Cemiplimab concentrations in serum and immunogenicity as measured in ADA in serum","definition_or_measurement_approach":"Pharmacokinetic assessment of cemiplimab serum concentrations and immunogenicity measured by anti-drug antibodies (ADA) in serum."}
Recruitment
- Planned Sample Size
- 279
- Recruitment Window Months
- 117
- Consent Approach
- Informed consent is obtained using country-specific subject information and informed consent form documents (multiple L1_SIS-ICF documents listed for France, Italy, Germany, Poland, Spain, Greece, Belgium, Ireland etc.). Documents include main ICF parts, pregnant partner information forms and specific local-language versions. The CTIS JSON lists functional contact 'Clinical Trial Information' and country-specific ICF document files but the provided data does not contain verbatim consent/assent process text or explicit age-specific assent procedures.
Geography
- Total Number Of Sites
- 43
- Total Number Of Participants
- 279
France
- Earliest CTIS Part Ii Submission Date
- 04-06-2024
- Latest Decision Or Authorization Date
- 26-06-2024
- Processing Time Days
- 22
- Number Of Sites
- 10
- Number Of Participants
- 16
Sites
- Site Name
- Hopital Ambroise Pare
- Department Name
- Dermatology and Oncology
- Contact Person Name
- Philippe Saiag
- Contact Person Email
- philippe.saiag@uvsq.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Dermato-oncology
- Contact Person Name
- Marie Beylot-Barry
- Contact Person Email
- marie.beylot-barry@chu-bordeaux.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Contact Person Name
- Eve-Marie Neidhardt
- Contact Person Email
- eve-marie.neidhardt@lyon.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Dermatology
- Contact Person Name
- Anne Bendicte Duval Modeste
- Contact Person Email
- ab.duval-modeste@chu-rouen.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Dermatology
- Contact Person Name
- Henri Montaudie
- Contact Person Email
- montaudie.h@chu-nice.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Dermatology
- Contact Person Name
- Stephane Dalle
- Contact Person Email
- stephane.dalle@chu-lyon.fr
- Site Name
- Hospital Hotel Dieu
- Department Name
- Dermatology
- Contact Person Name
- Gaelle Quereux
- Contact Person Email
- gaelle.quereux@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Dermatology
- Contact Person Name
- Marie Enquebecq
- Contact Person Email
- menquebecq@chu-grenoble.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Dermatology
- Contact Person Name
- Geraldine Jeudy
- Contact Person Email
- geraldine.jeudy@chu-dijon.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Dermatology
- Contact Person Name
- Laurent Mortier
- Contact Person Email
- laurent.mortier@chru-lille.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 04-06-2024
- Latest Decision Or Authorization Date
- 01-07-2024
- Processing Time Days
- 27
- Number Of Sites
- 8
- Number Of Participants
- 21
Sites
- Site Name
- Azienda USL Toscana Centro
- Department Name
- Medical Oncology
- Contact Person Name
- Vincenzo De Giorgi
- Contact Person Email
- vincenzo.degiorgi@unifi.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Dermatology
- Contact Person Name
- Ketty Peris
- Contact Person Email
- ketty.peris@unicatt.it
- Site Name
- Universita Degli Studi Di Brescia
- Department Name
- Oncology
- Contact Person Name
- Valeria Tovazzi
- Contact Person Email
- valeria.tovazzi@gmail.com
- Site Name
- Alma Mater Studiorum Universita Di Bologna
- Department Name
- Dermatology
- Contact Person Name
- Emi Dika
- Contact Person Email
- emi.dika3@unibo.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Oncology Melanoma, Sarcoma and Rare Tumors
- Contact Person Name
- Carolina Cimminiello
- Contact Person Email
- carolina.cimminiello@ieo.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Medical Oncology
- Contact Person Name
- Paolo Bossi
- Contact Person Email
- paolo.bossi@hunimed.eu
- Site Name
- Istituto Nazionale Dei Tumori
- Department Name
- Oncology
- Contact Person Name
- Paolo Antonio Ascierto
- Contact Person Email
- paolo.ascierto@gmail.com
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Dermatology
- Contact Person Name
- Pietro Quaglino
- Contact Person Email
- pietro.quaglino@unito.it
Germany
- Earliest CTIS Part Ii Submission Date
- 04-06-2024
- Latest Decision Or Authorization Date
- 27-06-2024
- Processing Time Days
- 23
- Number Of Sites
- 9
- Number Of Participants
- 18
Sites
- Site Name
- SLK-Kliniken Heilbronn GmbH
- Department Name
- Hematology/Oncology
- Contact Person Name
- Uwe Martens
- Contact Person Email
- uwe.martens@slk-kliniken.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Dermatology
- Contact Person Name
- Nicole Kreuzberg
- Contact Person Email
- nicole.kreuzberg@uk-koeln.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Dermato-oncology
- Contact Person Name
- Lucie Heinzerling
- Contact Person Email
- lucie.heinzerling@med.uni-muenchen.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Dermatology
- Contact Person Name
- Lukas Flatz
- Contact Person Email
- lukas.flatz@med.uni-tuebingen.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Dermato-oncology
- Contact Person Name
- Axel Hauschild
- Contact Person Email
- ahauschild@dermatology.uni-kiel.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Dermato-oncology
- Contact Person Name
- Jessica Cecile Hassel
- Contact Person Email
- jessica.hassel@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden
- Department Name
- Dermatology
- Contact Person Name
- Friedegund Meier
- Contact Person Email
- friedegund.meier@uniklinikum-dresden.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Dermatology
- Contact Person Name
- Dirk Schadendorf
- Contact Person Email
- dirk.schadendorf@uk-essen.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Dermatology
- Contact Person Name
- Stephan Grabbe
- Contact Person Email
- stephan.grabbe@unimedizin-mainz.de
Poland
- Earliest CTIS Part Ii Submission Date
- 04-06-2024
- Latest Decision Or Authorization Date
- 23-07-2024
- Processing Time Days
- 49
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Nowotwór Tkanek Miękkich, Kości i Czerniaków
- Contact Person Name
- Piotr Rutkowski
- Contact Person Email
- rutkowskip@coi.waw.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 04-06-2024
- Latest Decision Or Authorization Date
- 26-06-2024
- Processing Time Days
- 22
- Number Of Sites
- 9
- Number Of Participants
- 11
Sites
- Site Name
- Instituto De Investigacion En Ciencias De La Salud Germans Trias I Pujol
- Department Name
- Oncology
- Contact Person Name
- Cristina Buges Sanchez
- Contact Person Email
- cbuges@iconcologia.net
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Clinical Oncology
- Contact Person Name
- Eduardo Castanon Alvarez
- Contact Person Email
- ecastanon@unav.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Medical Oncology
- Contact Person Name
- Ivan Marquez Rodas
- Contact Person Email
- ivanpantic@hotmail.com
- Site Name
- Genesis Care Hospital San Francisco de Asis
- Department Name
- Medical Oncology
- Contact Person Name
- Jose Angel Garcia Cuesta
- Contact Person Email
- jose.garcia@genesiscare.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Medical Oncology
- Contact Person Name
- Roberto Pedro Diaz Beveridge
- Contact Person Email
- diaz_rob@gva.es
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Dermatology
- Contact Person Name
- Lucia Turrion Merino
- Contact Person Email
- luciaturrion@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Dermatology
- Contact Person Name
- Susana Puig Sarda
- Contact Person Email
- susipuig@gmail.com
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Medical Oncology
- Contact Person Name
- Hector Augusto Aguilar Andino
- Contact Person Email
- haguilar@fivo.org
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Dermatology
- Contact Person Name
- Javier Canueto Alvarez
- Contact Person Email
- jcanueto@usal.es
Greece
- Earliest CTIS Part Ii Submission Date
- 04-06-2024
- Latest Decision Or Authorization Date
- 19-07-2024
- Processing Time Days
- 45
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Andreas Syngros Hospital Of Venereal And Dermatological Diseases
- Department Name
- University Dermatology and Venereology Clinic
- Contact Person Name
- Alexander Stratigos
- Contact Person Email
- msm@syggros.gr
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- 1st Department of Dermatology Clinic AUTH
- Contact Person Name
- Aimilios Lallas
- Contact Person Email
- aimilios.lallas@dermoscopy-ids.org
Belgium
- Earliest CTIS Part Ii Submission Date
- 04-06-2024
- Latest Decision Or Authorization Date
- 26-06-2024
- Processing Time Days
- 22
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- UZ Leuven
- Department Name
- Oncology
- Contact Person Name
- Oliver Bechter
- Contact Person Email
- oliver.bechter@uzleuven.be
Ireland
- Earliest CTIS Part Ii Submission Date
- 04-06-2024
- Latest Decision Or Authorization Date
- 26-06-2024
- Processing Time Days
- 22
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- University Hospital Galway
- Department Name
- Medical Oncology
- Contact Person Name
- Paul Donnellan
- Contact Person Email
- paul.donnellan@hse.ie
- Site Name
- Cork University Maternity Hospital
- Department Name
- Medical Oncology
- Contact Person Name
- Derek Power
- Contact Person Email
- derek.power1@hse.ie
- Site Name
- St Vincent's University Hospital
- Department Name
- Medical Oncology
- Contact Person Name
- John Crown
- Contact Person Email
- john.crown@ccrt.ie
Sponsor
Primary sponsor
- Full Name
- Regeneron Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- CRO, Clinical database Management and Independent Data Monitoring Committee
- Name
- Icon Public Limited Company
- Responsibilities
- Reading Centers - Reading CT Scans and MRIs
- Name
- Excelya Greece CRO Single Member S.A.
- Responsibilities
- Start-up, RA and EC submissions, site contracting and site payments management
Third parties
- {"country":"Slovakia","full_name":"SanaClis s.r.o.","duties_or_roles":"Investigational Product Distribution to Sites, Return, and Destruction","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"Speciality laboratory - PDL1 IHC Testing","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Public Limited Company","duties_or_roles":"Reading Centers - Reading CT Scans and MRIs","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"Investigational Product Packaging","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"Central Laboratory - sample analysis and storage","organisation_type":"Industry"}
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"Interactive Voice Response System/ Interactive Web Response System","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Icon Clinical Research (U.K.) Limited","duties_or_roles":"Pharmacovigilience Services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"Specialty Lab (MRD ctDNA analysis)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Andersonbrecon Inc.","duties_or_roles":"Investigational Product Distribution to Sites, Return, and Destruction","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"Central Laboratory - sample analysis and storage","organisation_type":"Industry"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"CRO, Clinical database Management and Independent Data Monitoring Committee","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"Start-up, RA and EC submissions, site contracting and site payments management","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"University Of Wisconsin","duties_or_roles":"Independent Statistics Vendor","organisation_type":"Educational Institution"}
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"eCOA","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Acumen Medical Communications LLC","duties_or_roles":"Patient Safety narratives","organisation_type":"Pharmaceutical company"}
- {"country":"Australia","full_name":"Trans Tasman Radiation Oncology Group Limited","duties_or_roles":"RT Plan data collection and review","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"Pharmaceutical Research Associates Greece A.E (Affiliated company of ICON Clinical Research Limited) - Site visits and monitoring activities","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- LIBTAYO 350 mg concentrate for solution for infusion.
- Active Substance
- CEMIPLIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- Authorised (marketing authorisation present: EU/1/19/1376/001)
- Maximum Dose
- 700 mg (maxDailyDoseAmount indicated in product data)
- Investigational Product Name
- matching Placebo with R2810
- Modality
- Other
- Authorisation Status
- Not authorised / N/A
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