Clinical trial • Phase III • Oncology
cetrelimab for Metastatic prostate cancer | Prostate cancer metastatic
Phase III trial of cetrelimab for Metastatic prostate cancer | Prostate cancer metastatic. 190 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic prostate cancer | Prostate cancer metastatic
- Trial Stage
- Phase III
- Drug Modality
- Bispecific antibody | Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 26-11-2024
- First CTIS Authorization Date
- 10-03-2025
Trial design
Phase III trial across 4 sites in Spain.
- Target Sample Size
- 190
- Trial Duration For Participant
- 990
Eligibility
Recruits 190 No vulnerable population selected (isVulnerablePopulationSelected: false).
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected: false)
Recruitment
- Planned Sample Size
- 190
- Recruitment Window Months
- 33
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 190
Spain
- Earliest CTIS Part Ii Submission Date
- 24-02-2025
- Latest Decision Or Authorization Date
- 20-10-2025
- Processing Time Days
- 238
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology Service
- Contact Person Name
- Emiliano Calvo Aller
- Contact Person Email
- emiliano.calvo@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology Service
- Contact Person Name
- Joaquín Mateo
- Contact Person Email
- jmateo@vhio.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology Service
- Contact Person Name
- David Olmos
- Contact Person Email
- davidolmos1977@gmail.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology Service
- Contact Person Name
- Bernard Doger de Speville
- Contact Person Email
- bernard.doger@startmadrid.com
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- JNJ-78278343
- Modality
- Bispecific antibody
- Investigational Product Name
- JNJ-63723283 (cetrelimab)
- Active Substance
- cetrelimab
- Modality
- Monoclonal antibody
- Investigational Product Name
- Taxane Chemotherapy
- Active Substance
- Taxane
- Modality
- Small molecule
- Investigational Product Name
- Androgen Receptor Pathway Inhibitors
- Active Substance
- Androgen receptor pathway inhibitors
- Modality
- Small molecule
- Combination Treatment
- Yes
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