Clinical trial • Phase I • Oncology
pembrolizumab for Sarcoma | Melanoma | Triple-negative breast cancer | Colorectal cancer | Non-small cell lung cancer
Phase I trial of pembrolizumab for Sarcoma | Melanoma | Triple-negative breast cancer | Colorectal cancer | Non-small cell lung cancer. open-label.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Sarcoma | Melanoma | Triple-negative breast cancer | Colorectal cancer | Non-small cell lung cancer
- Trial Stage
- Phase I
- Drug Modality
- Other | Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 16-10-2024
- First CTIS Authorization Date
- 08-11-2024
Trial design
open-label Phase I trial in Germany, Italy.
- Open Label
- Yes
- Target Sample Size
- 23
- Trial Duration For Participant
- 999
Recruitment
- Planned Sample Size
- 23
- Recruitment Window Months
- 32
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 23
Germany
- Earliest CTIS Part Ii Submission Date
- 25-10-2024
- Latest Decision Or Authorization Date
- 08-11-2024
- Processing Time Days
- 14
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Charité Campus Benjamin Franklin (CBF), Comprehensive Cancer Center
- Principal Investigator Name
- Sebastian Ochsenreither
- Principal Investigator Email
- sebastian.Ochsenreither@charite.de
- Contact Person Name
- Sebastian Ochsenreither
- Contact Person Email
- sebastian.Ochsenreither@charite.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
- Principal Investigator Name
- Guy Ungerechts
- Principal Investigator Email
- guy.ungerechts@nct-heidelberg.de
- Contact Person Name
- Guy Ungerechts
- Contact Person Email
- guy.ungerechts@nct-heidelberg.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Klinik für Dermatologie, Venerologie und Allergologie
- Principal Investigator Name
- Kai-Martin Thoms
- Principal Investigator Email
- kai.thoms@med.uni-goettingen.de
- Contact Person Name
- Kai-Martin Thoms
- Contact Person Email
- kai.thoms@med.uni-goettingen.de
- Site Name
- Universitätsklinikum Tübingen
- Department Name
- Phase I Klinik, NET Zentrum; Abteilung Innere Medizin VIII
- Principal Investigator Name
- Ulrich Lauer
- Principal Investigator Email
- Ulrich.Lauer@med.uni-tuebingen.de
- Contact Person Name
- Ulrich Lauer
- Contact Person Email
- Ulrich.Lauer@med.uni-tuebingen.de
- Site Name
- Krankenhaus Nordwest GmbH
- Department Name
- Klinik für Hämatologie und Onkologie
- Principal Investigator Name
- Elke Jäger
- Principal Investigator Email
- jaeger.elke@khnw.de
- Contact Person Name
- Elke Jäger
- Contact Person Email
- jaeger.elke@khnw.de
Italy
- Earliest CTIS Part Ii Submission Date
- 08-10-2025
- Latest Decision Or Authorization Date
- 24-10-2025
- Processing Time Days
- 16
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- Clinical Medicine and Surgery
- Principal Investigator Name
- Roberto Bianco
- Principal Investigator Email
- robianco@unina.it
- Contact Person Name
- Roberto Bianco
- Contact Person Email
- robianco@unina.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Gianluca Del Conte
- Principal Investigator Email
- delconte.gianluca@hsr.it
- Contact Person Name
- Gianluca Del Conte
- Contact Person Email
- delconte.gianluca@hsr.it
- Site Name
- Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Vanesa Gregorc
- Principal Investigator Email
- vanesa.gregorc@ircc.it
- Contact Person Name
- Vanesa Gregorc
- Contact Person Email
- vanesa.gregorc@ircc.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Department of Medical Oncology and Hematology
- Principal Investigator Name
- Matteo Simonelli
- Principal Investigator Email
- matteo.simonelli@hunimed.eu
- Contact Person Name
- Matteo Simonelli
- Contact Person Email
- matteo.simonelli@hunimed.eu
Sponsor
Primary sponsor
- Full Name
- Valo Therapeutics Oy
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Finland
Investigational products
- Investigational Product Name
- PeptiCRAd-1
- Modality
- Other
- Investigational Product Name
- pembrolizumab
- Active Substance
- pembrolizumab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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