Clinical trial • Phase I • Oncology
pembrolizumab for Thymic carcinoma|Nasopharyngeal cancer|Anal cancer|Head and neck squamous cell carcinoma|Epithelial ovarian cancer|Cutaneous melanoma|Mesothelioma|Non-small cell lung cancer|Esophagogastric cancer|Triple-negative breast cancer|Microsatellite instability-high colorectal cancer|Clear cell renal cell carcinoma
Phase I trial of pembrolizumab for Thymic carcinoma|Nasopharyngeal cancer|Anal cancer|Head and neck squamous cell carcinoma|Epithelial ovarian cancer|Cuta…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Thymic carcinoma|Nasopharyngeal cancer|Anal cancer|Head and neck squamous cell carcinoma|Epithelial ovarian cancer|Cutaneous melanoma|Mesothelioma|Non-small cell lung cancer|Esophagogastric cancer|Triple-negative breast cancer|Microsatellite instability-high colorectal cancer|Clear cell renal cell carcinoma
- Trial Stage
- Phase I
- Drug Modality
- Other|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 22-09-2023
- First CTIS Authorization Date
- 25-01-2024
Trial design
open-label, none/not specified-controlled Phase I trial across 7 sites in Germany, Spain, Italy and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 123
Eligibility
Recruits 123 Vulnerable population selected: true. No further information on consent or assent handling available..
- Vulnerable Population
- Vulnerable population selected: true. No further information on consent or assent handling available.
Recruitment
- Planned Sample Size
- 123
- Recruitment Window Months
- 35
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 97
Germany
- Earliest CTIS Part Ii Submission Date
- 13-10-2023
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 886
- Number Of Sites
- 2
- Number Of Participants
- 33
Sites
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- #1500: Innere Klinik (Tumorforschunt)
- Contact Person Name
- Martin Schuler
- Contact Person Email
- Martin.schuler@uk-essen.de
- Site Name
- Technische Universitat Dresden
- Department Name
- #1501: Medizinische Klinik und Poliklinik I
- Contact Person Name
- Martin Wermke
- Contact Person Email
- Martin.Wermke@uniklinikum-dresden.de
Spain
- Earliest CTIS Part Ii Submission Date
- 13-11-2023
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 855
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- #2500:Servicio ONCO UITM
- Contact Person Name
- Elena Garralda Cabanas
- Contact Person Email
- egarralda@vhio.net
Italy
- Earliest CTIS Part Ii Submission Date
- 13-10-2023
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 885
- Number Of Sites
- 2
- Number Of Participants
- 22
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- 2000:S.C. Oncologia Medica 1
- Contact Person Name
- Filippo de Braud
- Contact Person Email
- debraud_studiclinici@istitutotumori.mi.it
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- 2001:Oncology and Hematology
- Contact Person Name
- Annalisa Fontana
- Contact Person Email
- fontana.annalisa@aou.mo.it
France
- Earliest CTIS Part Ii Submission Date
- 23-11-2023
- Latest Decision Or Authorization Date
- 12-03-2026
- Processing Time Days
- 841
- Number Of Sites
- 2
- Number Of Participants
- 30
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- #1000:Oncology
- Contact Person Name
- Caroline EVEN
- Contact Person Email
- Caroline.even@gustaveroussy.fr
- Site Name
- Centre Leon Berard
- Department Name
- #1001:Oncology
- Contact Person Name
- Phillippe CASSIER
- Contact Person Email
- phillippe.cassier@lyon.unicancer.fr
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- KFA115
- Modality
- Other
- Investigational Product Name
- pembrolizumab
- Active Substance
- pembrolizumab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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