THE IPI - Trial in Advanced Melanoma: Melanoma Patients With Advanced Disease
Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
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.