Clinical trial • Phase II • Oncology
Xdivane for Melanoma
Phase II trial of Xdivane for Melanoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Melanoma
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 11-08-2025
- First CTIS Authorization Date
- 08-12-2025
Trial design
Xdivane versus Opdivo®; comparator arm includes Opdivo® (dose and schedule not specified in the record).-controlled Phase II trial across 10 sites in Romania, Spain.
- Comparator
- Xdivane versus Opdivo®; comparator arm includes Opdivo® (dose and schedule not specified in the record).
- Target Sample Size
- 306
- Trial Duration For Participant
- 319
Eligibility
Recruits 306 Vulnerable population selected (isVulnerablePopulationSelected: true); no further details on vulnerable population, consent or assent handling provided in the record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true); no further details on vulnerable population, consent or assent handling provided in the record.
Recruitment
- Planned Sample Size
- 306
- Recruitment Window Months
- 10
- Consent Approach
- No informed consent or assent process details provided in the record.
Geography
- Total Number Of Sites
- 10
- Total Number Of Participants
- 34
Romania
- Earliest CTIS Part Ii Submission Date
- 30-09-2025
- Latest Decision Or Authorization Date
- 08-12-2025
- Processing Time Days
- 69
- Number Of Sites
- 3
- Number Of Participants
- 19
Sites
- Site Name
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
- Department Name
- Oncology
- Contact Person Name
- Laurentia Gales
- Contact Person Email
- laurentia.gales@arensia-em.com
- Site Name
- Centrul De Oncologie SF Nectarie S.R.L.
- Department Name
- Oncology
- Contact Person Name
- Michael Schenker
- Contact Person Email
- mike_schenker@yahoo.com
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Oncology
- Contact Person Name
- Tudor Ciuleanu
- Contact Person Email
- office@iocn.ro
Spain
- Earliest CTIS Part Ii Submission Date
- 13-10-2025
- Latest Decision Or Authorization Date
- 13-02-2026
- Processing Time Days
- 123
- Number Of Sites
- 7
- Number Of Participants
- 15
Sites
- Site Name
- Hospital San Pedro De Alcantara
- Department Name
- Medical Oncology
- Contact Person Name
- Pablo Ayala de Miguel
- Contact Person Email
- pabloayala2003@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Contact Person Name
- Guillermo Antonio de Velasco Oria de Rueda
- Contact Person Email
- gdvelasco.gdv@gmail.com
- Site Name
- Hospital Quironsalud Malaga
- Department Name
- Medical Oncology
- Contact Person Name
- Jose Miguel Jurado García
- Contact Person Email
- jmjurado88@gmail.com
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Oncology
- Contact Person Name
- Miguel Angel Berciano Guerrero
- Contact Person Email
- migueberci@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Contact Person Name
- Ana Arance
- Contact Person Email
- amarance@clinic.cat
- Site Name
- Hospital Universitario De Badajoz
- Department Name
- Medical Oncology
- Contact Person Name
- Marta González Cordero
- Contact Person Email
- martagcordero@gmail.com
- Site Name
- Hospital Quironsalud Malaga (duplicate entry not specified)
- Department Name
- Medical Oncology
Sponsor
Primary sponsor
- Full Name
- Intas Pharmaceuticals Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- India
Investigational products
- Investigational Product Name
- Xdivane
- Investigational Product Name
- Opdivo®
- Modality
- Monoclonal antibody
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