A study to find out whether treating patients who have liver metastases from eye melanoma with radiofrequency ablation combined with ipilimumab, will kill the tumor without them having too many adverse events.

• Conditions: nresectable uveal melanoma liver metastasis; MedDRA version: 14.0Level: HLTClassification code 10030052Term: Ocular melanomasSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004200-38-NL
• Lead Sponsor: KI-AV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-05
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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.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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified