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

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.

Timeline

Start

2011-10

Primary completion

2012-09

Completion

2013-09

Publications

• Zimmer L, Eigentler TK, Kiecker F, Simon J, Utikal J, Mohr P, Berking C, Kampgen E, Dippel E, Stadler R, Hauschild A, Fluck M, Terheyden P, Rompel R, Loquai C, Assi Z, Garbe C, Schadendorf D. Open-label, multicenter, single-arm phase II DeCOG-study of ipilimumab in pretreated patients with different subtypes of metastatic melanoma. J Transl Med. 2015 Nov 6;13:351. doi: 10.1186/s12967-015-0716-5.
• Zimmer L, Vaubel J, Mohr P, Hauschild A, Utikal J, Simon J, Garbe C, Herbst R, Enk A, Kampgen E, Livingstone E, Bluhm L, Rompel R, Griewank KG, Fluck M, Schilling B, Schadendorf D. Phase II DeCOG-study of ipilimumab in pretreated and treatment-naive patients with metastatic uveal melanoma. PLoS One. 2015 Mar 11;10(3):e0118564. doi: 10.1371/journal.pone.0118564. eCollection 2015.

Drugs

Indications