Clinical trial • Phase I/II • Oncology|Dermatology
Ipilimumab for Stage II melanoma
Phase I/II trial of Ipilimumab for Stage II melanoma. None/Not specified-controlled. 90 participants.
Overview
- Trial Therapeutic Area
- Oncology|Dermatology
- Trial Disease
- Stage II melanoma
- Trial Stage
- Phase I/II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 18-07-2023
- First CTIS Authorization Date
- 05-02-2024
Trial design
None/Not specified-controlled Phase I/II trial across 8 sites in Netherlands, Germany, Sweden.
- Comparator
- None/Not specified
- Target Sample Size
- 90
Eligibility
Recruits 90 Vulnerable population not selected; no specific consent/assent handling described..
- Vulnerable Population
- Vulnerable population not selected; no specific consent/assent handling described.
Recruitment
- Planned Sample Size
- 90
- Recruitment Window Months
- 101
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 90
Netherlands
- Earliest CTIS Part Ii Submission Date
- 09-01-2024
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 832
- Number Of Sites
- 6
- Number Of Participants
- 80
Sites
- Site Name
- Academisch Ziekenhuis Leiden
- Department Name
- Medical Oncology
- Principal Investigator Name
- H. B Flintstone
- Principal Investigator Email
- anonymous@lumc.nl
- Contact Person Name
- H. B Flintstone
- Contact Person Email
- anonymous@lumc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Medical Oncology
- Principal Investigator Name
- F. Flintstone
- Principal Investigator Email
- anonymous@umcu.nl
- Contact Person Name
- F. Flintstone
- Contact Person Email
- anonymous@umcu.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Medical Oncology
- Principal Investigator Name
- D. Flintstone
- Principal Investigator Email
- anonymous@umcg.nl
- Contact Person Name
- D. Flintstone
- Contact Person Email
- anonymous@umcg.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Medical Oncology
- Principal Investigator Name
- C Flintstone
- Principal Investigator Email
- anonymous@nki.nl
- Contact Person Name
- C Flintstone
- Contact Person Email
- anonymous@nki.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Medical Oncology
- Principal Investigator Name
- E B Flintstone
- Principal Investigator Email
- anonymous@emc.nl
- Contact Person Name
- E B Flintstone
- Contact Person Email
- anonymous@emc.nl
- Site Name
- Amsterdam UMC
- Department Name
- Medical Oncology
- Principal Investigator Name
- A. B Flintstone
- Principal Investigator Email
- anonymous@amsterdamumc.nl
- Contact Person Name
- A. B Flintstone
- Contact Person Email
- anonymous@amsterdamumc.nl
Germany
- Earliest CTIS Part Ii Submission Date
- 11-06-2025
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 317
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Department of Dermatology
- Principal Investigator Name
- Teresa Amaral
- Principal Investigator Email
- Teresa.Amaral@med.uni-tuebingen.de
- Contact Person Name
- Teresa Amaral
- Contact Person Email
- Teresa.Amaral@med.uni-tuebingen.de
Sweden
- Earliest CTIS Part Ii Submission Date
- 28-05-2025
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 328
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Department of Oncology
- Principal Investigator Name
- Axel Nelson
- Principal Investigator Email
- axel.nelson@vgregion.se
- Contact Person Name
- Axel Nelson
- Contact Person Email
- axel.nelson@vgregion.se
Sponsor
Primary sponsor
- Full Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- Ipilimumab
- Active Substance
- Ipilimumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intradermal
- Route
- Intradermal
- Investigational Product Name
- Nivolumab
- Active Substance
- Nivolumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intradermal
- Route
- Intradermal
- Combination Treatment
- Yes
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