Clinical trial • Phase I • Oncology
Clinical trial in Advanced PRAME-positive cancers|Malignant melanoma|Synovial sarcoma|Non-small cell lung cancer|Cholangiocarcinoma|Small cell lung cancer|Adenoid cystic carcinoma|Endometrial cancer|Clear cell endometrial carcinoma|Papillary serous endometrial carcinoma|Ovarian cancer|Uterine cancer
Phase I trial for Advanced PRAME-positive cancers|Malignant melanoma|Synovial sarcoma|Non-small cell lung cancer|Cholangiocarcinoma|Small cell lung cancer…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced PRAME-positive cancers|Malignant melanoma|Synovial sarcoma|Non-small cell lung cancer|Cholangiocarcinoma|Small cell lung cancer|Adenoid cystic carcinoma|Endometrial cancer|Clear cell endometrial carcinoma|Papillary serous endometrial carcinoma|Ovarian cancer|Uterine cancer
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 31-05-2024
- First CTIS Authorization Date
- 12-09-2024
Trial design
Phase I trial across 19 sites in France, Italy, Spain.
- Biomarker Stratified
- True, biomarker: PRAME-positive
- Target Sample Size
- 330
Eligibility
Recruits 330 Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on consent/assent handling provided in the available documents..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on consent/assent handling provided in the available documents.
Recruitment
- Planned Sample Size
- 520
- Recruitment Window Months
- 54
Geography
- Total Number Of Sites
- 19
- Total Number Of Participants
- 520
France
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 20-02-2026
- Processing Time Days
- 616
- Number Of Sites
- 7
- Number Of Participants
- 160
Sites
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Department Name
- Unité de Recherche Clinique
- Contact Person Name
- Iphigénie KORAKIS
- Contact Person Email
- korakis.iphigenie@iuct-oncopole.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Drug Development Department (DITEP)
- Contact Person Name
- Kaïssa OUALI
- Contact Person Email
- Kaissa.ouali@gustaveroussy.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Contact Person Name
- Isabelle RAY-COQUARD
- Contact Person Email
- isabelle.ray-coquard@lyon.unicancer.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medical Oncology
- Contact Person Name
- Dominique Berton
- Contact Person Email
- dominique.berton@ico.unicancer.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- Oncology
- Contact Person Name
- Melanie Dos-Santos
- Contact Person Email
- m.dossantos@baclesse.unicancer.fr
- Site Name
- Centre Antoine Lacassagne
- Department Name
- Oncology
- Contact Person Name
- Philippe Follana
- Contact Person Email
- philippe.follana@nice.unicancer.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Dermatology
- Contact Person Name
- Celeste Lebbe
- Contact Person Email
- celeste.lebbe@php.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 08-08-2024
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 573
- Number Of Sites
- 4
- Number Of Participants
- 160
Sites
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Melanoma, Cancer Immunotherapy and Development Therapeutics Unit
- Contact Person Name
- Paolo, Antonio Ascierto
- Contact Person Email
- p.ascierto@istitutotumori.na.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Divisione di sviluppo nuovi farmaci per Terapie Innovative
- Contact Person Name
- Dario Trapani
- Contact Person Email
- dario.trapani@ieo.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Medical Oncology and Hematology
- Contact Person Name
- Massimo Di Nicola
- Contact Person Email
- massimo.dinicola@istitutotumori.mi.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Dipartimento Scienze della Salute della Donna, del Bambino e di Sanita' Pubblica
- Contact Person Name
- Vanda Salutari
- Contact Person Email
- vanda.salutari@policlinicogemelli.it
Spain
- Earliest CTIS Part Ii Submission Date
- 06-09-2024
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 563
- Number Of Sites
- 8
- Number Of Participants
- 200
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Roberta Mazzeo
- Contact Person Email
- robertamazzeo@vhio.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Contact Person Name
- Javier Torres Jimenez
- Contact Person Email
- javiertorresjimenez92@gmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncology
- Contact Person Name
- Ana Santaballa Bertran
- Contact Person Email
- santaballa_ana@gva.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Contact Person Name
- Victor Moreno
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Clinica Universidad De Navarra (Madrid)
- Department Name
- Oncology
- Contact Person Name
- Eduardo Castanon Alvarez
- Contact Person Email
- ecastanon@unav.es
- Site Name
- Clinica Universidad De Navarra (Pamplona)
- Department Name
- Oncology
- Contact Person Name
- Eduardo Castanon Alvarez
- Contact Person Email
- ecastanon@unav.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Contact Person Name
- Marta Gil Martin
- Contact Person Email
- mgilmartin@iconcologia.net
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Contact Person Name
- Pablo Gajate Borau
- Contact Person Email
- pgajateborau@gmail.com
Sponsor
Primary sponsor
- Full Name
- Immunocore Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
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