Neoadjuvant Immunotherapy for Patients With High-risk Eye Melanoma

Sponsor
Inge Marie Svane
Study ID
NCT07501117
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Uveal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The goal of this clinical trial is to investigate the safety and feasibility of neoadjuvant immunotherapy for patients with high-risk uveal melanoma. The main question is: \- Is neoadjuvant treatment with nivolumab and ipilimumab safe and feasible for patientt with high-riks uveal melanoma? In addition pathological response, distant metastases-free survival, overall survival and immunological changes in the tumor microenviroenment after therapy will be assesed.

Key Dates

First listed
Mar 30, 2026
Start date
Jun 29, 2026
Status verified
Mar 2026
Primary completion
Jun 1, 2029
Completion
Jun 1, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant nivolumab + ipilimumab
    Neoadjuvant nivolumab + ipilimumab

Primary Outcome Measure

Number of patients experiencing CTCAE grade ≥ 3 AEs and the occurrence of any treatment related adverse event (AEs) [ Time Frame: Until 6 months post treatment ]

Central Contacts

Related Studies