Phase II trial of nilotinib in the treatment of patients with c-KIT mutated advanced acral and mucosal melanoma.
Disease site: Melanoma
Treatment modality: Systemic therapy
NICAM is a phase II, open label, single arm, multicentre trial to evaluate the efficacy of nilotinib in advanced c-KIT mutated advanced acral and mucosal melanoma. The trial will also correlate c-KIT mutation, gene amplification and over expression with response to treatment and survival.
NICAM closed to recruitment in August 2014. 219 patients were registered for screening from 16 UK sites over 5 years. 29 of these patients were eligible for trial entry and received nilotinib 400 mg, twice daily, for as long as they gained clinical benefit. Participants will be followed up until objective disease progression; after this they will be followed up for life.
Chief Investigator: Dr James Larkin, The Royal Marsden NHS Foundation Trust
ICR-CTSU Scientific Lead: Professor Judith Bliss
Trial management contact: [email protected]
Sponsors: The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research
Funding: Cancer Research UK (CRUK/09/028) and Novartis
Further information including recruitment progress is available from the following link:
UK Clinical Trials Gateway
Patient friendly information is available from the following link:
Publications and presentations
Larkin JMG, Turajlic S, Nathan PD, Lorigan P, Stamp G, Gonzalez de Castro D, Martin N, Griffiths J, Edmonds K, Sarker S, James MG, A'Hern R, Coombes G, Snowdon C, Bliss JM, Gore ME, Marais R. A Phase II trial of nilotinib in the treatment of patients with KIT mutated advanced acral and mucosal melanoma (NICAM). J Clin Oncol. 2011; 29(15 Suppl): TPS229.