Clinical trial • Phase III • Oncology
pembrolizumab for Melanoma|Malignant melanoma stage II|Malignant melanoma stage III
Phase III trial of pembrolizumab for Melanoma|Malignant melanoma stage II|Malignant melanoma stage III.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Melanoma|Malignant melanoma stage II|Malignant melanoma stage III
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 30-11-2023
- First CTIS Authorization Date
- 09-04-2024
Trial design
GME751 (proposed pembrolizumab biosimilar) vs Keytruda (pembrolizumab, US-licensed and EU-approved); dose and schedule not specified-controlled Phase III trial across 25 sites in Romania, Germany, Italy and others.
- Comparator
- GME751 (proposed pembrolizumab biosimilar) vs Keytruda (pembrolizumab, US-licensed and EU-approved); dose and schedule not specified
- Target Sample Size
- 281
- Trial Duration For Participant
- 654
Recruitment
- Planned Sample Size
- 281
- Recruitment Window Months
- 21
Geography
- Total Number Of Sites
- 25
- Total Number Of Participants
- 136
Romania
- Earliest CTIS Part Ii Submission Date
- 12-01-2024
- Latest Decision Or Authorization Date
- 10-07-2025
- Processing Time Days
- 545
- Number Of Sites
- 2
- Number Of Participants
- 25
Sites
- Site Name
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
- Department Name
- Medical Oncology II Department, Radiotherapy I Department
- Contact Person Name
- Laurentia Nicoleta Gales
- Contact Person Email
- laurentia.gales.ext@arensia-em.com
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Radiotherapy Department
- Contact Person Name
- Tudor Ciuleanu
- Contact Person Email
- tudor.ciuleanu.ext@arensi-em.com
Germany
- Earliest CTIS Part Ii Submission Date
- 29-03-2024
- Latest Decision Or Authorization Date
- 10-11-2025
- Processing Time Days
- 591
- Number Of Sites
- 3
- Number Of Participants
- 14
Sites
- 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
- Site Name
- Eberhard Karls Universitaet Tuebingen
- Department Name
- Dermatology
- Contact Person Name
- Ulrike Leiter Stoeppke
- Contact Person Email
- Ulrike.leiter@med.uni-tuebingen.de
- Site Name
- Fachklinik Hornheide e.V.
- Department Name
- Oncology
- Contact Person Name
- Michael Fluck
- Contact Person Email
- michael.fluck@fachklinik-hornheide.de
Italy
- Earliest CTIS Part Ii Submission Date
- 20-03-2024
- Latest Decision Or Authorization Date
- 11-02-2025
- Processing Time Days
- 328
- Number Of Sites
- 4
- Number Of Participants
- 20
Sites
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- San Matteo Phase I Clinical Trial Unit and Experimental Therapy
- Contact Person Name
- Silvia Chiellino
- Contact Person Email
- s.chiellino@smatteo.pv.it
- Site Name
- Humanitas Research Hospital
- Department Name
- Unità di Fase I - Istituto Clinico Humanitas
- Contact Person Name
- Agnese Losurdo
- Contact Person Email
- agnese.losurdo@cancercenter.humanitas.it
- Site Name
- Azienda Ospedaliera Universitaria Mater Domini
- Department Name
- Centro di Sperimentazioni di Fase I in Oncologia Medica e Oncoematologia-UOC Oncologia Medica Trasla
- Contact Person Name
- Pierosandro Tagliaferri
- Contact Person Email
- tagliaferri@unicz.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- SC Oncologia Clinica Sperimentale del Melanoma, Immunoterapia e Terapie Innovative
- Contact Person Name
- Ester Simeone
- Contact Person Email
- ester.simeone@gmail.com
Lithuania
- Earliest CTIS Part Ii Submission Date
- 09-02-2024
- Latest Decision Or Authorization Date
- 13-03-2025
- Processing Time Days
- 398
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Klaipedos universiteto ligonine VšĮ
- Department Name
- 2600: Chemotherapy
- Contact Person Name
- Alvydas Cesas
- Contact Person Email
- cesasalvydas@gmail.com
- Site Name
- Nacionalinis vezio institutas
- Department Name
- Conservative Tumour Therapy
- Contact Person Name
- Vincas Urbonas
- Contact Person Email
- vincas.urbonas@nvi.lt
France
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 19-02-2025
- Processing Time Days
- 342
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Besancon University Hospital Center
- Department Name
- Oncologie médicale
- Contact Person Name
- Charlee Nardin
- Contact Person Email
- cnardin@chu-besancon.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Dermatologie
- Contact Person Name
- Gaelle Quereux
- Contact Person Email
- gaelle.quereux@chu-nantes.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 17-03-2024
- Latest Decision Or Authorization Date
- 12-02-2025
- Processing Time Days
- 332
- Number Of Sites
- 12
- Number Of Participants
- 59
Sites
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Oncología
- Contact Person Name
- Pablo Cerezuela Fuentes
- Contact Person Email
- pcerezuelaf@seom.org
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncología Médica
- Contact Person Name
- María Julia Lostes Bardaji
- Contact Person Email
- jlostes@vhio.net
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncología Médica
- Contact Person Name
- Manuel Pedregal
- Contact Person Email
- Manuel.pedregal@startmadrid.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncología Médica
- Contact Person Name
- José Manzano Mozo
- Contact Person Email
- jmanzano@iconcologia.net
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncología Médica
- Contact Person Name
- Margarita Majem Tarruella
- Contact Person Email
- mmajem@santpau.cat
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Oncología Médica
- Contact Person Name
- Luis de la Cruz Merino
- Contact Person Email
- luis.cruz.sspa@juntadeandalucia.es
- Site Name
- Hospital Unviersitario Miguel Servet
- Department Name
- Oncología
- Contact Person Name
- Teresa Puertolas Hernandez
- Contact Person Email
- tjpuertolas@gmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncología
- Contact Person Name
- Alejandro Falcón González
- Contact Person Email
- alejandro.falcon.sspa@juntadeandalucia.es
- Site Name
- Hospital San Pedro De Alcantara
- Department Name
- Oncología
- Contact Person Name
- Pablo Ayala
- Contact Person Email
- pablo.ayala@salud-juntaex.es
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Oncología
- Contact Person Name
- Maria José Juan Fita
- Contact Person Email
- mjjuan@fivo.org
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Oncología Médica
- Contact Person Name
- Teresa Curiel
- Contact Person Email
- teresa.curiel.garcia@sergas.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Onco-Hematologia Pediatrica
- Contact Person Name
- Roberto Diaz Beveridge
- Contact Person Email
- diaz_rob@gva.es
Sponsor
Primary sponsor
- Full Name
- H e x a l AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- GME751 (proposed pembrolizumab biosimilar)
- Active Substance
- pembrolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous
- Authorisation Status
- Investigational (biosimilar candidate)
- Investigational Product Name
- Keytruda (pembrolizumab, US-licensed and EU-approved)
- Active Substance
- pembrolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous
- Authorisation Status
- Authorized (US-licensed and EU-approved)
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