Clinical trial • Phase I • Oncology
pembrolizumab for Advanced solid tumors
Phase I trial of pembrolizumab for Advanced solid tumors. 215 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors
- Trial Stage
- Phase I
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 06-12-2023
- First CTIS Authorization Date
- 22-02-2024
Trial design
Phase I trial across 9 sites in France, Belgium, Spain and others.
- Target Sample Size
- 215
Eligibility
Recruits 215 Vulnerable population selected; no details on consent or assent handling available in the record..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling available in the record.
Recruitment
- Planned Sample Size
- 215
- Recruitment Window Months
- 39
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 80
France
- Earliest CTIS Part Ii Submission Date
- 19-12-2023
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 785
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Medical Oncology - DITEP
- Contact Person Name
- Antoine HOLLEBECQUE
- Contact Person Email
- antoine.hollebecque@gustaveroussy.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Contact Person Name
- Philippe CASSIER
- Contact Person Email
- philippe.cassier@lyon.unicancer.fr
Belgium
- Earliest CTIS Part Ii Submission Date
- 19-12-2023
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 776
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- UZ Leuven
- Department Name
- General Medical Oncology
- Contact Person Name
- Oliver Bechter
- Contact Person Email
- oliver.bechter@uzleuven.be
Spain
- Earliest CTIS Part Ii Submission Date
- 19-12-2023
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 785
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de Oncología
- Contact Person Name
- Elena Elez Fernández
- Contact Person Email
- meelez@vhio.net
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Servicio de Oncología
- Contact Person Name
- Emiliano Calvo Aller
- Contact Person Email
- emiliano.calvo@startmadrid.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Servicio de Oncología
- Contact Person Name
- Ignacio Matos Garcia
- Contact Person Email
- imatos@unav.es
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Servicio de Oncología
- Contact Person Name
- Andrés Cervantes Ruipérez
- Contact Person Email
- andres.cervantes@uv.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Servicio de Oncología
- Contact Person Name
- Ignacio Matos Garcia
- Contact Person Email
- imatos@unav.es
Denmark
- Earliest CTIS Part Ii Submission Date
- 19-12-2023
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 780
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Rigshospitalet
- Department Name
- Rigshospitalet; Fase 1 Enhed - Onkologi
- Contact Person Name
- Kristoffer Rohrberg
- Contact Person Email
- kristoffer.staal.rohrberg@regionh.dk
Sponsor
Primary sponsor
- Full Name
- Vividion Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- VVD-133214
- Investigational Product Name
- Pembrolizumab
- Active Substance
- pembrolizumab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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