eye melanoma ocular melanoma
Conditions
Interventions
The patients will undergo radiofrequency ablation on a liver metastasis, and a
biopsy will be taken from a liver metastasis. After that the patients will
receive 4 courses of ipilimumab. Also biopsi
Sponsors
Nederlands Kanker Instituut
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adults at least 18 years of age 2. World Health Organization (WHO) Performance Status 0 or I 3. Histologically or cytologically confirmed unresectable metastatic uveal melanoma 4. Subjects must have at least two liver metastases (one irRC measurable) 5. No prior systemic treatment (including chemotherapy, vaccine therapy, monoclonal Ab-treatment, IL-2) 6. Local pretreatment of uveal melanoma metastases is allowed, except for chemotherapy containing procedures (e.g. chemoembolisation), and as long patients have progresses with at least two measurable lesions now 7. Women of child bearing potential must agree to use a reliable form of contraceptive during the study treatment period and for at least 70 days following the last dose of study drug 8. LDH
Exclusion criteria
Exclusion criteria: 1. Cerebral or meningeal metastasized uveal melanoma 2. Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy; 3. Active infection requiring therapy, positive serology for hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA) 4. History of or current immunodeficiency disease, splenectomy or splenic irradiation; Prior allogeneic stem cell transplantation; 5. Pregnancy or nursing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine safety and tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) and recommended phase two dose (RPTD) of the combination of ipilimumab with RFA in patients with unresectable, pathologically confirmed hepatic metastases of uveal melanoma in the phase Ib part of the study. To determine efficacy and safety in the phase II extension cohort. | — |
Secondary
| Measure | Time frame |
|---|---|
| * OS * irPFS * Clinical response benefit (RECIST 1.1) * Duration of response * Response according to MHC expression on the melanoma cells | — |
Countries
Netherlands
Outcome results
None listed