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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Nivolumab 3 mg/kg Ipilimumab 1 mg/kg
National Center for Cancer Immune Therapy, Department of Oncology, Herlev Hospital
Herlev, Herlev, Denmark
RECRUITINGNumber of patients experiencing CTCAE grade ≥ 3 AEs and the occurrence of any treatment related adverse event (AEs)
Safety is evaluated by the Common Terminology Criteria (CTCAE) for Adverse Events version 6.0 and include the number of patients experiencing CTCAE grade ≥ 3 AEs and the occurrence of any treatment related adverse event (AEs) until 6 months post treatment.
Time frame: Until 6 months post treatment
Proportion of patients who complete the treatment regimen
Feasibility is evaluated as the proportion of patients who complete the treatment regimen defined as receiving at least one dose of both nivolumab and ipilimumab, followed by enucleation
Time frame: Until 6 months post treatment
Pathological response rate
The fraction of pathological responses according to standard evaluation criteria
Time frame: through study completion, an average of 3 years
Objective response
Size and extend of the tumor at baseline and after the second dose of nivolumab and ipilimumab.
Time frame: through study completion, an average of 3 years
Distant metastases free survival (DMFS)
DMFS will be evaluated as the time from treatment initiation to the development of any distant metastasis or death.
Time frame: Until 6 months post treatment
Overall survival (OS)
OS will be evaluated as the time from treatment initiation to death from any cause
Time frame: Until 6 months post treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.