1133P - Efficacy and safety of ipilimumab in patients with pretreated, ocular melanoma: experience from Italian clinics participating in the European Expand...

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Immunotherapy
Skin cancers
Presenter Michele Maio
Authors M. Maio1, V. Chairion Sileni2, L. Pilla3, S.V.L. Nicoletti4, L. Di Guardo5, P. Queirolo6, F. De Galitiis7, M. Mandala8, M. Guida9, P.A. Ascierto10
  • 1Division Of Medical Oncology And Immunotherapy, University Hospital of Siena, 53100 - Siena/IT
  • 2Department Of Oncology, Oncology Institute of Veneto, 35128 - Padova/IT
  • 3Department Of Oncology, San Raffaele Hospital, 20132 - Milan/IT
  • 4Department Of Medical Oncology, Scientific Institute of Romagna for the Study and Treatment of Cancer (IRST), Meldola/IT
  • 5Department Of Medical Oncology, National Cancer Institute, Milan/IT
  • 6National Institute For Cancer Research, San Martino Hospital, Genoa/IT
  • 7Oncology, IDI-IRCCS, 00167 - Rome/IT
  • 8Oncology And Haematology, Ospedali Riuniti di Bergamo, 24100 - Bergamo/IT
  • 9Medical Oncology, National Institute of Cancer, 70124 - Bari/IT
  • 10Unit Of Medical Oncology And Innovative Therapy, Istituto Nazionale Tumori Fondazione G. Pascale, Napoli/IT



Ocular melanoma is a rare malignancy with an incidence of 5.3–10.9 cases per million per year (Papastefanou and Cohen; J Skin Cancer 2011). Currently, the treatment of metastatic ocular melanoma is limited by the lack of an effective systemic therapy. The EAP provided an opportunity to assess the activity and safety of ipilimumab in patients with ocular melanoma outside of a controlled clinical trial in patients from the EAP in Italy.


Ipilimumab was available upon physician request for patients aged ≥16 years with stage III (unresectable) or stage IV skin, ocular or mucosal melanoma, who had failed or did not tolerate previous treatments and for whom no therapeutic option was available. Patients were treated with ipilimumab 3 mg/kg every 3 weeks for 4 doses. Tumour assessments were conducted at baseline and after completion of induction therapy using immune-related response criteria. Patients were monitored for adverse events (AEs), including immune-related AEs, within 3 to 4 days of each scheduled visit using Common Terminology Criteria for Adverse Events v.3.0.


Of 848 Italian patients participating in the EAP, 83 (9.8%) had ocular melanoma. Of these 83 patients, 55 have data available. With a median follow-up of 3 months, the disease control rate among 46 evaluable patients was 34.8%, including 3 patients with a partial response and 13 with stable disease. As of April 2012, median progression-free survival and overall survival among patients with ocular melanoma were 2.9 months and 5.9 months, respectively. In total, 63.6% patients reported an AE of any grade, most of which were drug-related (47.3%). Grade 3/4 AEs, which were reported by 20.0% patients, were only considered drug-related in 5.4%. AEs were generally manageable and most resolved with treatment as per protocol-specific guidelines.


Safety and early efficacy results are similar to experience in other melanoma populations, thus suggesting that treatment of ocular melanoma with ipilimumab warrants further investigation in prospective clinical trials.


M. Maio: Michele Maio has acted as an advisor for Bristol-Myers Squibb and Roche.

V. Chairion Sileni: Vanna Chiaron Sileni has acted as an advisor for Bristol-Myers Squibb, Roche, GlaxoSmithKline, Merck Sharp & Dohme and Schering-Plough.

P. Queirolo: Paola Queirolo has acted as an advisor for Roche, GlaxoSmithKline, Bristol-Myers Squibb and Schering-Plough and received honoraria from Bristol-Myers Squibb and Roche.

P.A. Ascierto: PA has served as a consultant/advisor for Merck Sharp & Dohme, and as an advisor to Bristol-Myers Squibb (BMS), Roche, GlaxoSmithKline, Amgen, Celgene, Medimmune and Novartis. He has received honoraria from BMS, Merck Sharp & Dohme and Roche.

All other authors have declared no conflicts of interest.