Clinical trial • Phase III • Oncology|Ophthalmology

Nivolumab for Uveal melanoma

Phase III trial of Nivolumab for Uveal melanoma. 15 participants.

Overview

Trial Therapeutic Area
Oncology|Ophthalmology
Trial Disease
Uveal melanoma
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
17-12-2025
First CTIS Authorization Date
04-02-2026

Trial design

Phase III trial across 1 site in Denmark.

Target Sample Size
15

Recruitment

Planned Sample Size
15
Recruitment Window Months
36

Geography

Total Number Of Sites
1
Total Number Of Participants
15

Denmark

Earliest CTIS Part Ii Submission Date
03-02-2026
Latest Decision Or Authorization Date
04-02-2026
Processing Time Days
1
Number Of Sites
1
Number Of Participants
15

Sites

Site Name
Herlev Hospital
Department Name
Department of Oncology, Herlev Hospital, Denmark
Principal Investigator Name
Inge Marie Svane
Principal Investigator Email
inge.marie.svane@regionh.dk
Contact Person Name
Inge Marie Svane
Contact Person Email
inge.marie.svane@regionh.dk
Number Of Participants
15

Sponsor

Primary sponsor

Full Name
Region Hovedstaden
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Investigational products

Investigational Product Name
Nivolumab
Active Substance
Nivolumab
Modality
Monoclonal antibody
Investigational Product Name
Ipilimumab
Active Substance
Ipilimumab
Modality
Monoclonal antibody
Combination Treatment
Yes

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