Clinical trial • Phase I • Oncology
Nivolumab for Cutaneous melanoma | Resectable high-risk cutaneous melanoma
Phase I trial of Nivolumab for Cutaneous melanoma | Resectable high-risk cutaneous melanoma. Randomised. 80 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Cutaneous melanoma | Resectable high-risk cutaneous melanoma
- Trial Stage
- Phase I
- Drug Modality
- Monoclonal antibody | Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 21-05-2025
- First CTIS Authorization Date
- 15-09-2025
Trial design
Randomised Phase I trial across 8 sites in Italy.
- Randomised
- Yes
- Target Sample Size
- 80
Eligibility
Recruits 80 Vulnerable populations selected (isVulnerablePopulationSelected=true); no details on consent or assent handling provided in the record.
- Vulnerable Population
- Vulnerable populations selected (isVulnerablePopulationSelected=true); no details on consent or assent handling provided in the record
Recruitment
- Planned Sample Size
- 80
- Recruitment Window Months
- 72
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 80
Italy
- Earliest CTIS Part Ii Submission Date
- 21-07-2025
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 273
- Number Of Sites
- 8
- Number Of Participants
- 80
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- SS Oncologia Medica Melanomi
- Principal Investigator Name
- Michele Del Vecchio
- Principal Investigator Email
- MICHELE.DELVECCHIO@istitutotumori.mi.it
- Contact Person Name
- Michele Del Vecchio
- Contact Person Email
- MICHELE.DELVECCHIO@istitutotumori.mi.it
- Site Name
- Hospital Santa Maria Della Misericordia
- Department Name
- SC Oncologia Medica
- Principal Investigator Name
- Mario Mandalà
- Principal Investigator Email
- mario.mandala@unipg.it
- Contact Person Name
- Mario Mandalà
- Contact Person Email
- mario.mandala@unipg.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- UOC Oncologia 2
- Principal Investigator Name
- Jacopo Pigozzo
- Principal Investigator Email
- jacopo.pigozzo@iov.veneto.it
- Contact Person Name
- Jacopo Pigozzo
- Contact Person Email
- jacopo.pigozzo@iov.veneto.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- UOSD Sarcomi e Tumori Rari
- Principal Investigator Name
- Virginia Ferraresi
- Principal Investigator Email
- VIRGINIA.FERRARESI@ifo.it
- Contact Person Name
- Virginia Ferraresi
- Contact Person Email
- VIRGINIA.FERRARESI@ifo.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Divisione Sviluppo Nuovi Farmaci per Terapie Innovative
- Principal Investigator Name
- Giuseppe Curigliano
- Principal Investigator Email
- giuseppe.curigliano@ieo.it
- Contact Person Name
- Giuseppe Curigliano
- Contact Person Email
- giuseppe.curigliano@ieo.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Melanoma. Cancer Immunotherapy and Development Therapeutics Unit
- Principal Investigator Name
- Paolo Antonio Ascierto
- Principal Investigator Email
- paolo.ascierto@gmail.com
- Contact Person Name
- Paolo Antonio Ascierto
- Contact Person Email
- paolo.ascierto@gmail.com
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- SSD di Immunoterapia
- Principal Investigator Name
- Laura Ridolfi
- Principal Investigator Email
- laura.ridolfi@irst.emr.it
- Contact Person Name
- Laura Ridolfi
- Contact Person Email
- laura.ridolfi@irst.emr.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- UOC Oncoematologia
- Principal Investigator Name
- Teresa Troiani
- Principal Investigator Email
- teresa.troiani@unicampania.it
- Contact Person Name
- Teresa Troiani
- Contact Person Email
- teresa.troiani@unicampania.it
Sponsor
Primary sponsor
- Full Name
- Fondazione Melanoma Onlus
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Italy
Investigational products
- Investigational Product Name
- Nivolumab
- Active Substance
- Nivolumab
- Modality
- Monoclonal antibody
- Investigational Product Name
- Ipilimumab
- Active Substance
- Ipilimumab
- Modality
- Monoclonal antibody
- Investigational Product Name
- MDNA11 (IL-2 Superkine)
- Active Substance
- MDNA11 (engineered IL-2)
- Modality
- Peptide/protein/enzyme
- Investigational Product Name
- Tocilizumab
- Active Substance
- Tocilizumab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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