Clinical trial • Phase I • Oncology
Pembrolizumab for Non-small cell lung cancer | Colorectal cancer | Gastric cancer | Melanoma
Phase I trial of Pembrolizumab for Non-small cell lung cancer | Colorectal cancer | Gastric cancer | Melanoma. adaptive. 400 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer | Colorectal cancer | Gastric cancer | Melanoma
- Trial Stage
- Phase I
- Drug Modality
- Other | Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 31-01-2024
- First CTIS Authorization Date
- 16-05-2024
Trial design
adaptive Phase I trial in Spain, France, Netherlands and others.
- Adaptive
- True, adaptive elements include dose escalation, dose confirmation and dose expansion cohorts (dose escalation study design described in trial details).
- Biomarker Stratified
- True, biomarker: Tertiary Lymphoid Structure (TLS) positivity with expansion cohorts in TLS+ CRC, GC, and NSCLC
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 400
Eligibility
Recruits 400 Vulnerable population selected (isVulnerablePopulationSelected = true). No details provided in the available documents on consent or assent handling for vulnerable participants..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). No details provided in the available documents on consent or assent handling for vulnerable participants.
Recruitment
- Planned Sample Size
- 400
- Recruitment Window Months
- 73
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 135
Spain
- Earliest CTIS Part Ii Submission Date
- 26-03-2024
- Latest Decision Or Authorization Date
- 16-05-2024
- Processing Time Days
- 51
- Number Of Sites
- 3
- Number Of Participants
- 35
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Elena Garralda Cabanas
- Principal Investigator Email
- egarralda@vhio.net
- Contact Person Name
- Elena Garralda Cabanas
- Contact Person Email
- egarralda@vhio.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Servicio de Oncologia Medica
- Principal Investigator Name
- Ivan Manuel Victoria Ruiz
- Principal Investigator Email
- ivictori@recerca.clinic.cat
- Contact Person Name
- Ivan Manuel Victoria Ruiz
- Contact Person Email
- ivictori@recerca.clinic.cat
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Pilar Garrido Lopez
- Principal Investigator Email
- pilargarridol@gmail.com
- Contact Person Name
- Pilar Garrido Lopez
- Contact Person Email
- pilargarridol@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 05-04-2024
- Latest Decision Or Authorization Date
- 22-05-2024
- Processing Time Days
- 47
- Number Of Sites
- 2
- Number Of Participants
- 35
Sites
- Site Name
- Institut Bergonie
- Department Name
- Oncologie medicale
- Principal Investigator Name
- Antoine Italiano
- Principal Investigator Email
- a.italiano@bordeaux.unicancer.fr
- Contact Person Name
- Antoine Italiano
- Contact Person Email
- a.italiano@bordeaux.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Departement de Medecine oncologique
- Principal Investigator Name
- Antoine Hollebecque
- Principal Investigator Email
- antoine.hollebecque@gustaveroussy.fr
- Contact Person Name
- Antoine Hollebecque
- Contact Person Email
- antoine.hollebecque@gustaveroussy.fr
Netherlands
- Earliest CTIS Part Ii Submission Date
- 03-05-2024
- Latest Decision Or Authorization Date
- 07-06-2024
- Processing Time Days
- 35
- Number Of Sites
- 2
- Number Of Participants
- 40
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Department of Medical Oncology
- Principal Investigator Name
- Fredericus Eskens
- Principal Investigator Email
- f.eskens@erasmusmc.nl
- Contact Person Name
- Fredericus Eskens
- Contact Person Email
- f.eskens@erasmusmc.nl
- Site Name
- Stichting Radboud University Medical Center
- Department Name
- Department of Medical Oncology
- Principal Investigator Name
- Ingrid Desar
- Principal Investigator Email
- Ingrid.Desar@radboudumc.nl
- Contact Person Name
- Ingrid Desar
- Contact Person Email
- Ingrid.Desar@radboudumc.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 06-05-2024
- Latest Decision Or Authorization Date
- 20-05-2024
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 25
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Oncology
- Principal Investigator Name
- Iwona Ługowska
- Principal Investigator Email
- obwf@nio.gov.pl
- Contact Person Name
- Iwona Ługowska
- Contact Person Email
- obwf@nio.gov.pl
Sponsor
Primary sponsor
- Full Name
- Amgen Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- AMG 355
- Modality
- Other
- First In Human
- Yes
- Investigational Product Name
- Pembrolizumab
- Active Substance
- Pembrolizumab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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