Clinical trial • Phase I • Oncology
pembrolizumab for Cutaneous melanoma (completely resected, Stage IIB–III)
Phase I trial of pembrolizumab for Cutaneous melanoma (completely resected, Stage IIB–III).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Cutaneous melanoma (completely resected, Stage IIB–III)
- Trial Stage
- Phase I
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 17-05-2024
- First CTIS Authorization Date
- 23-08-2024
Trial design
Randomised, active comparator arms: eu-approved keytruda (pembrolizumab) and us-licensed keytruda (pembrolizumab); investigational formulation ct-p51 (pembrolizumab). dose and schedule not specified in the record.-controlled Phase I trial across 16 sites in Croatia, Italy, Slovenia and others.
- Randomised
- Yes
- Comparator
- Active comparator arms: EU-approved Keytruda (pembrolizumab) and US-licensed Keytruda (pembrolizumab); investigational formulation CT-P51 (pembrolizumab). Dose and schedule not specified in the record.
- Target Sample Size
- 97
Eligibility
Recruits 97 Vulnerable populations not selected; no consent or assent details provided in the record..
- Vulnerable Population
- Vulnerable populations not selected; no consent or assent details provided in the record.
Recruitment
- Planned Sample Size
- 97
- Recruitment Window Months
- 30
Geography
- Total Number Of Sites
- 16
- Total Number Of Participants
- 83
Croatia
- Earliest CTIS Part Ii Submission Date
- 29-08-2024
- Latest Decision Or Authorization Date
- 05-09-2024
- Processing Time Days
- 7
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Specijalna Bolnica Medico
- Department Name
- oncology
- Contact Person Name
- Davor Kust
- Contact Person Email
- Davor.kust@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 05-06-2024
- Latest Decision Or Authorization Date
- 27-08-2024
- Processing Time Days
- 83
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Azienda Ospedaliera Universitaria Senese
- Department Name
- UOC Immonoterapia Oncologica
- Contact Person Name
- Michele Maio
- Contact Person Email
- mmaiocro@gmail.com
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Oncology Department
- Contact Person Name
- Laura Ridolfi
- Contact Person Email
- Laura.ridolfi@irst.emr.it
Slovenia
- Earliest CTIS Part Ii Submission Date
- 05-06-2024
- Latest Decision Or Authorization Date
- 23-08-2024
- Processing Time Days
- 79
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- Institute Of Oncology Ljubljana
- Department Name
- Department of Surgical Oncology
- Contact Person Name
- Barbara Peric
- Contact Person Email
- bperic@onko-i.si
Poland
- Earliest CTIS Part Ii Submission Date
- 05-06-2024
- Latest Decision Or Authorization Date
- 27-08-2024
- Processing Time Days
- 83
- Number Of Sites
- 1
- Number Of Participants
- 11
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Centrum Wsparcia Badan Klinicznych UCK Osrodek Badan Klinicznych Wczesnych Faz
- Contact Person Name
- Anna Kowalczyk
- Contact Person Email
- akow@gumed.edu.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 05-06-2024
- Latest Decision Or Authorization Date
- 23-08-2024
- Processing Time Days
- 79
- Number Of Sites
- 8
- Number Of Participants
- 30
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Contact Person Name
- Sofia Espana Fernandez
- Contact Person Email
- sofia.ef@iconcologia.net
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- UOC Immonoterapia Oncologica
- Contact Person Name
- Michele Maio
- Contact Person Email
- mmaiocro@gmail.com
- Site Name
- Hospital San Pedro De Alcantara
- Department Name
- Medical Oncology
- Contact Person Name
- Pablo Ayala de Miguel
- Contact Person Email
- pablo.ayala@salud-juntaex.es
- Site Name
- Hospital Universitari Dexeus Grupo Quironsalud
- Department Name
- Medical Oncology
- Contact Person Name
- Maria Gonzalez Cao
- Contact Person Email
- mgonzalezcao@oncorosell.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Medical Oncology
- Contact Person Name
- Manuel Zalabardo Aguilar
- Contact Person Email
- manuel.zalabardo@ibima.eu
- Site Name
- Hospital Universitario De Torrejon
- Department Name
- Oncology
- Contact Person Name
- Luis Cabezon Gutierrez
- Contact Person Email
- lcabezon@torrejonsalud.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Oncology
- Contact Person Name
- Guillermo Antonio De Velasco Oria de Rueda
- Contact Person Email
- gdvelasco.gdv@gmail.com
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Oncology
- Contact Person Name
- Luis Fernandez Morales
- Contact Person Email
- LFernandez@tauli.cat
Romania
- Earliest CTIS Part Ii Submission Date
- 12-08-2024
- Latest Decision Or Authorization Date
- 06-09-2024
- Processing Time Days
- 25
- Number Of Sites
- 3
- Number Of Participants
- 21
Sites
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Medical Oncology
- Contact Person Name
- Tudor Eliade Ciuleanu
- Contact Person Email
- tudor.ciuleanu.ext@arensia-em.com
- Site Name
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
- Department Name
- Medical Oncology
- Contact Person Name
- Laurentia Nicoleta Gales
- Contact Person Email
- laurentia.gales@arensia-em.com
- Site Name
- Centrul De Oncologie SF Nectarie S.R.L.
- Department Name
- Oncology
- Contact Person Name
- Michael Schenker
- Contact Person Email
- mike_schenker@yahoo.com
Sponsor
Primary sponsor
- Full Name
- Celltrion Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Korea, Republic of
Investigational products
- Investigational Product Name
- CT-P51
- Active Substance
- pembrolizumab
- Modality
- Monoclonal antibody
- Authorisation Status
- Investigational (CT-P51)
- Investigational Product Name
- Keytruda (EU-approved)
- Active Substance
- pembrolizumab
- Modality
- Monoclonal antibody
- Authorisation Status
- EU-approved
- Investigational Product Name
- Keytruda (US-licensed)
- Active Substance
- pembrolizumab
- Modality
- Monoclonal antibody
- Authorisation Status
- US-licensed
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