Phase 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) - SECIRA-UM trial

KI-AV0 个研究点开始时间: 2011年12月5日最近更新: 2012年4月3日

试验速览

暂无简介。

•1.Adults at least 18 years of age
•2.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) – at least one feasible for RFA
•5.No prior systemic or local treatment
•6.No immunosuppressive medications
•8.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
•9.Men must agree to the use of male contraception during the study treatment period and for at least 180 days after the last dose of study drug.
•10. Absence of additional severe and/or uncontrolled concurrent disease
•11. No prior, or ongoing other malignancy, except adequately treated basal cell or squamous cell skin cancer, cervical cancer in situ or adequately treated other cancer with eradicative intent for which the patient has been continuously disease-free for > 2 years.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 38
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 0

•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.Prior immunotherapy
•4.Known history of infection with HIV
•5.Active infection requiring therapy, positive serology for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA)
•6.Underlying medical conditions that, in the Investigator's opinion, will make the administration of study treatment hazardous or obscure the interpretation of toxicity determination or adverse events;
•7.Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids;
•8. History of or current immunodeficiency disease, splenectomy or splenic irradiation; prior allogeneic stem cell transplantation;
•9.Use of other investigational drugs before study drug administration for systemic malignancy
•10.Pregnancy or nursing.

发起方

KI-AV