Clinical trial • Phase II • Oncology|Dermatology
pembrolizumab for Melanoma (resected, Stage IIB–III)
Phase II trial of pembrolizumab for Melanoma (resected, Stage IIB–III).
Overview
- Trial Therapeutic Area
- Oncology|Dermatology
- Trial Disease
- Melanoma (resected, Stage IIB–III)
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 03-05-2024
- First CTIS Authorization Date
- 28-08-2024
Trial design
Keytruda (pembrolizumab) — comparator mentioned; dose/schedule not specified-controlled Phase II trial across 10 sites in Estonia, Lithuania, Poland and others.
- Comparator
- Keytruda (pembrolizumab) — comparator mentioned; dose/schedule not specified
- Target Sample Size
- 48
Recruitment
- Planned Sample Size
- 48
- Recruitment Window Months
- 24
Geography
- Total Number Of Sites
- 10
- Total Number Of Participants
- 116
Estonia
- Earliest CTIS Part Ii Submission Date
- 29-10-2024
- Latest Decision Or Authorization Date
- 19-11-2024
- Processing Time Days
- 21
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Tartu University Hospital
- Principal Investigator Name
- Kertu Kuldsaar
- Principal Investigator Email
- kertu.kuldsaar@kliinikum.ee
- Contact Person Name
- Kertu Kuldsaar
- Contact Person Email
- kertu.kuldsaar@kliinikum.ee
Lithuania
- Earliest CTIS Part Ii Submission Date
- 09-08-2024
- Latest Decision Or Authorization Date
- 28-08-2024
- Processing Time Days
- 19
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
- Principal Investigator Name
- Domas Vaitiekus
- Principal Investigator Email
- domas.vaitiekus@kaunoklinikos.lt
- Contact Person Name
- Domas Vaitiekus
- Contact Person Email
- domas.vaitiekus@kaunoklinikos.lt
Poland
- Earliest CTIS Part Ii Submission Date
- 06-08-2024
- Latest Decision Or Authorization Date
- 30-08-2024
- Processing Time Days
- 24
- Number Of Sites
- 2
- Number Of Participants
- 17
Sites
- Site Name
- Ip Clinic Sp. z o.o.
- Principal Investigator Name
- Małgorzata Ułańska
- Principal Investigator Email
- malgorzata.ulanska@ipclinil.pl
- Contact Person Name
- Małgorzata Ułańska
- Contact Person Email
- malgorzata.ulanska@ipclinil.pl
- Site Name
- Krakowskie Centrum Medyczne Sp. z o.o.
- Principal Investigator Name
- Michał Parkitny
- Principal Investigator Email
- feasibility@futuremeds.com
- Contact Person Name
- Michał Parkitny
- Contact Person Email
- feasibility@futuremeds.com
Romania
- Earliest CTIS Part Ii Submission Date
- 27-05-2024
- Latest Decision Or Authorization Date
- 02-09-2024
- Processing Time Days
- 98
- Number Of Sites
- 4
- Number Of Participants
- 51
Sites
- Site Name
- Arensia Exploratory Medicine S.R.L.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Tudor Eliade Ciuleanu
- Principal Investigator Email
- Tudor.ciuleanu.ext@arensia-em.com
- Contact Person Name
- Tudor Eliade Ciuleanu
- Contact Person Email
- Tudor.ciuleanu.ext@arensia-em.com
- Site Name
- Arensia Clinics S.R.L.
- Department Name
- Oncology
- Principal Investigator Name
- Laura Ciurea
- Principal Investigator Email
- laura.ciurea.ext@arensia-em.com
- Contact Person Name
- Laura Ciurea
- Contact Person Email
- laura.ciurea.ext@arensia-em.com
- Site Name
- Arensia Exploratory Medicine S.R.L.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Laurentia Nicoleta Gales
- Principal Investigator Email
- Laurentia.gales@arensia-em.com
- 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
- Principal Investigator Name
- Michael Schenker
- Principal Investigator Email
- Mike_schenker@yahoo.com
- Contact Person Name
- Michael Schenker
- Contact Person Email
- Mike_schenker@yahoo.com
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 19-08-2024
- Latest Decision Or Authorization Date
- 02-09-2024
- Processing Time Days
- 14
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
- Department Name
- Medical Oncology Clinic
- Principal Investigator Name
- Petranka Troyanova
- Principal Investigator Email
- prof.petranka.troyanova@gmail.com
- Contact Person Name
- Petranka Troyanova
- Contact Person Email
- prof.petranka.troyanova@gmail.com
- Site Name
- Multiprofile Hospital for Active Treatment Sveta Sofia
- Department Name
- Department of Medical Oncology
- Principal Investigator Name
- Marchela Koleva
- Principal Investigator Email
- marchela.koleva.ext@arensia-em.com
- Contact Person Name
- Marchela Koleva
- Contact Person Email
- marchela.koleva.ext@arensia-em.com
Sponsor
Primary sponsor
- Full Name
- Formycon AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- FYB206
- Modality
- Monoclonal antibody
- Investigational Product Name
- Keytruda
- Active Substance
- pembrolizumab
- Modality
- Monoclonal antibody
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