I have a long-standing interest in the field of clinical and translational cancer research and I have been involved in several (more than 50) clinical trials as principal or sub-investigator. Since 2009 I focused my activity in early-phase clinical development of anticancer new drugs (molecular targeted agents; immunotherapeutics agents) inside the clinical Pharmacology Unit, being responsible for the clinical management of the all the phase I studies conducted at the Humanitas Cancer Center.
Since 2014 I became Head of Neuroncology at the Humanitas Cancer Center, being part of the Multidisciplinary Neurongologic Team and conducting clinical trials with new immunotherapeutic agents. I’m principal investigator of several translational projects in the field of Neuroncology and Immuno-Neuroncology aimed to find prognostic or predictive biomarkers for the clinical management of patients with brain tumors.
My principle fields of research interest are
- Development of anticancer new drugs
- Immuno-oncology
- Neuro-oncology
- Translational Oncology
Other fields of interest
- Rare Thoracic Malignancies (Mesothelioma, Thymoma)
- Germ-cell tumors
- High-dose Chemotherapy, Autologous Transplantations
I’m author or co-author of about 40 articles in peer-reviewed journals and ad hoc-reviewer for several international scientific journals. I presented as presenting author (oral presentations) the results of many significant works at the most important International Oncology Meetings, as ASCO (American Society of Clinical Oncology), ESMO (European Association of Medical Oncology), SNO (Society of Neuroncology).
- Ott PA, Piha-Paul SA, Munster P, Pishvaian MJ, van Brummelen EM, Cohen RB, Gomez-Roca C, Ejadi S, Stein M, Chan E, Simonelli M, Morosky A, Saraf S, Emancipator K, Koshiji M, Bennouna J. – Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with recurrent carcinoma of the anal canal. Ann Oncol. 2017 May 1;28(5):1036-1041.
- Simonelli M, Zucali P, Santoro A, Thomas MB, De Braud FG, Borghaei H, Berlin J, Denlinger CS, Noberasco C, Rimassa L, Kim TY, English PA, Abbattista A, Gallo Stampino C, Carpentieri M, Williams JA. – Phase I study of PF-03446962, a fully human monoclonal antibody against activin receptor–like kinase 1 in patients with hepatocellular carcinoma. Ann Oncol. 2016 Sep;27(9):1782-7.
- Santoro A, Simonelli M, Rodriguez-Lope C, Zucali P, Camacho LH, Granito A, Senzer N, Rimassa L, Abbadessa G, Schwartz B, Lamar M, Savage RE, Bruix J. A – Phase-1b study of tivantinib (ARQ 197) in adult patients with hepatocellular carcinoma and cirrhosis. Br J Cancer. 2013 Jan 15;108(1):21-4.
- Simonelli M, Zucali PA, Lorenzi E, Rubino L, De Vincenzo F, De Sanctis R, Perrino M, Mancini L, Di Tommaso L, Rimassa L, Masci G, Zuradelli M, Suter MB, Bertossi M, Fattuzzo G, Giordano L, Roncalli MG, Santoro A. – Phase I pharmacokinetic and pharmacodynamic study of lapatinib in combination with sorafenib in patients with advanced refractory solid tumors. Eur J Cancer. 2013 Mar;49(5):989-98.
- Simonelli M, Rosti G, Banna GL, Pedrazzoli P; on behalf of the Italian Germ cell cancer Group (IGG) and Gruppo Italiano Trapianto Midollo Osseo, Cellule Staminali Emopoietiche e Terapia Cellulare (GITMO). – Intensified chemotherapy with stem-cell rescue in germ-cell tumors. Ann Oncol. 2012 Apr;23(4):815-22.