Last updated on February 2018

A Study of Fotemustine(FTM) Vs FTM and Ipilimumab (IPI) or IPI and Nivolumab in Melanoma Brain Metastasis


Brief description of study

This Phase 3, open-label, triple arm study aims to evaluate the overall survival (OS) of fotemustine versus the combination of ipilimumab and fotemustine or the combination of Ipilimumab and nivolumab in patients with metastatic melanoma with brain metastasis.

Detailed Study Description

Metastatic melanoma is an aggressive tumor associated with very poor prognosis. Brain metastases develop in nearly half of MM pts and in 30 to 40% of these subjects, the brain is the first site of relapse. The limited activity of available agents, along with relative resistance to radiotherapy and poor CNS penetration of most chemotherapeutic agents, make this one of the most daunting problems in oncology. There is no optimal systemic or local therapy for melanoma metastatic to the brain. Though MM pts with brain metastases have been excluded from most phase II-III trials with ipilimumab, initial evidences suggest that the anti-CTLA-4 monoclonal antibody ipilimumab might be active as single-agent also in this clinical setting. Preliminary results from the NIBIT-M1 phase II trial suggest for the safety and efficacy of the combination of fotemustine plus ipilimumab in MM pts with or w/o brain metastases.Recent data from a phase I study in MM pts w/o brain metastases have shown that concurrent administration of ipilimumab (3 mg/kg) plus the anti-PD1 mAb nivolumab (1 mg/kg) induced objective responses in 53% of pts, with a tumor reduction of 80% in 41% of pts, with an 82% 1-year OS, and with an acceptable safety profile.Based on the long-term follow-up of the NIBIT-M1 study, and on the activity of the concurrent administration of ipilimumab and nivolumabthe NIBIT-M2 study will explore the efficacy of the combination of ipilimumab and fotemustine or ipilimumab and nivolumab versus fotemustine alone in pts with melanoma metastatic to the brain.

Clinical Study Identifier: NCT02460068

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Michele Guida, PhD,MD

Medical Oncology, Cancer Institute "Giovanni Paolo II"
Bari, Italy
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Mario Mandalà, PhD, MD

Medical Oncology, Pope Giovanni XXIII Hospital
Bergamo, Italy
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Paola Queirolo, PhD,MD

National Institute for Cancer Research
Genoa, Italy
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Massimo Guidoboni, PhD, MD

Immunotherapy and Somatic Cell Therapy Unit, Scientific Institute of Romagna
Meldola, Italy
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Michele Del Vecchio, PhD, MD

Surgical Oncology, National Cancer Institute
Milan, Italy
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Anna Maria Di Giacomo, PhD,MD

European Institute of Oncology
Milan, Italy
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Anna Maria Di Giacomo, PhD,MD

Medical Oncology and Innovative Therapy, National Cancer Institute
Naples, Italy
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Vanna Chiaron Sileni

esophageal and melanoma oncology, Istituto Oncologico Veneto
Padua, Italy
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Anna Maria Di Giacomo, PhD,MD

Medical Oncology, National Cancer Institute "Regina Elena"
Rome, Italy
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Anna Maria Di Giacomo, PhD,MD

Medical Oncology and Immunotherapy Unit, University Hospital of Siena
Siena, Italy
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Pietro Quaglino, PhD, MD

S C Dermatology, A.O.U. City of Health and Science of Turin
Turin, Italy
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Recruitment Status: Open


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