THE IPI - Trial in Advanced Melanoma: Melanoma Patients With Advanced Disease

Sponsor
Prof. Dr. med. Dirk Schadendorf
Study ID
NCT01355120
Phase
PHASE2
Status
Completed

Conditions

  • Ocular Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    Ipilimumab monotherapy 3mg/kg by four infusion every 3 weeks

Study Details

This is an open-label, multi-center, single-arm clinical phase II study to further characterize the efficacy and safety of ipilimumab in patients with or without systemic pretreatment metastatic ocular melanoma. The DeCOG-MM-PAL11-Trial will be continued only for patients with ocular melanoma because sufficient numbers of cutaneous and mucosal melanoma patients have already been recruited. In order to allow the separate subgroup analysis as planned in the protocol for ocular melanoma it is mandatory to focus the recruitment to this patient population. Only this will guarantee a valid evaluation of all cohorts. Ocular melanoma is defined as melanomas originated from uvea, the choroid, the ciliary body and conjunctiva. (see McCartney ACE "Pathology of ocular melanomas" British Medical Bulltta, 1995, Vol 51, No 3 pp 678-693) The same criteria and treatment procedure as those used before will be applied for the patients with advanced ocular melanoma. Since no treatment standard in those patients does exist, also patients without prior systemic treatment can be included in this study. Therefore, the 5th inclusion criterion has been adapted in order to enrol the eligible patients.

Key Dates

Start date
Oct 31, 2011
Status verified
Jun 2014
Primary completion
Sep 30, 2012
Completion
Sep 30, 2013

Study Design

Enrollment
171 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: a human immunoglobulin
    Four infusions (i.v.) of 3mg/kg Ipilimumab in week 1, week 4, week 7 and week 10

Primary Outcome Measure

Overall survival [ Time Frame: alive 12 months after date from the first study drug adminstration ]

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