Phase Ib/II study exploring safety and efficacy of the combination of ipilimumab with radiofrequency ablation (RFA) in patients with unresectable uveal melanoma liver metastasis (SECIRA-UM) - RFA combined with ipilimumab in uveal melanoma/SECIRA-UM

ederlands Kanker Instituut0 个研究点目标入组 38 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•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 <= 2x ULN

•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.

发起方

ederlands Kanker Instituut