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)

Recruiting

Conditions: eye melanoma
ocular melanoma
10030054

Registration Number: NL-OMON41385

Lead Sponsor: ederlands Kanker Instituut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 38

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 <= 2x ULN

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine safety and tolerability, dose limiting toxicities (DLTs), maximum<br /><br>tolerated dose (MTD) and recommended phase two dose (RPTD) of the combination<br /><br>of ipilimumab with RFA in patients with unresectable, pathologically confirmed<br /><br>hepatic metastases of uveal melanoma in the phase Ib part of the study.<br /><br>To determine efficacy and safety in the phase II extension cohort.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* OS<br /><br>* irPFS<br /><br>* Clinical response benefit (RECIST 1.1)<br /><br>* Duration of response<br /><br>* Response according to MHC expression on the melanoma cells</p><br>