Clinical trial • Phase IV • Oncology
Pembrolizumab for Metastatic uveal melanoma
Phase IV trial of Pembrolizumab for Metastatic uveal melanoma. open-label, none/not specified-controlled. 54 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic uveal melanoma
- Trial Stage
- Phase IV
- Drug Modality
- Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 21-06-2024
- First CTIS Authorization Date
- 25-07-2024
Trial design
open-label, none/not specified-controlled Phase IV trial across 1 site in France.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 54
Eligibility
Recruits 54 Vulnerable population not selected; no special consent/assent handling described..
- Vulnerable Population
- Vulnerable population not selected; no special consent/assent handling described.
Recruitment
- Planned Sample Size
- 54
- Recruitment Window Months
- 54
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 54
France
- Earliest CTIS Part Ii Submission Date
- 23-07-2024
- Latest Decision Or Authorization Date
- 25-07-2024
- Processing Time Days
- 2
- Number Of Sites
- 1
- Number Of Participants
- 54
Sites
- Site Name
- Institut Curie
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Manuel RODRIGUES
- Principal Investigator Email
- drci.promotion@curie.fr
- Contact Person Name
- Manuel RODRIGUES
- Contact Person Email
- drci.promotion@curie.fr
Sponsor
Primary sponsor
- Full Name
- Institut Curie
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- Pembrolizumab
- Active Substance
- Pembrolizumab
- Modality
- Monoclonal antibody
- Investigational Product Name
- Lenvatinib
- Active Substance
- Lenvatinib
- Modality
- Small molecule
- Combination Treatment
- Yes
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