168
Participants
Start Date
December 31, 2012
Primary Completion Date
January 31, 2018
Study Completion Date
January 31, 2020
Fotemustine
Fotemustine: fotemustine at 100 mg/mq intravenously (i.v.) over 60 minutes once every week for 3 doses, and once every 3 weeks from week 9 for 6 doses.
Fotemustine and Ipilimumab
Fotemustine and ipilimumab:fotemustine 100 mg/m2 i.v. over 60 minutes once every week for 3 weeks (Weeks 1, 2, 3) plus ipilimumab at 10 mg/kg i.v. over 90 minutes every 3 weeks for 4 cycles (Weeks 1, 4, 7, 10); fotemustine 100 mg/m2 i.v. over 60 minutes once every 3 weeks from week 9 for 6 doses plus ipilimumab at 10 mg/kg i.v. over 90 minutes every 12 weeks from week 24.
Ipilimumab and nivolumab
ipilimumab and nivolumab: ipilimumab 3 mg/kg i.v over 90 minutes combined with nivolumab 1 mg/kg i.v over 60 minutes every three weeks for 4 doses, then nivolumab 3 mg/kg IV over 60 minutes every two weeks.
NOT_YET_RECRUITING
S C Dermatology, A.O.U. City of Health and Science of Turin, Turin
NOT_YET_RECRUITING
National Institute for Cancer Research, Genoa
RECRUITING
Surgical Oncology, National Cancer Institute, Milan
ACTIVE_NOT_RECRUITING
European Institute of Oncology, Milan
RECRUITING
Medical Oncology, Pope Giovanni XXIII Hospital, Bergamo
NOT_YET_RECRUITING
esophageal and melanoma oncology, Istituto Oncologico Veneto, Padua
RECRUITING
Immunotherapy and Somatic Cell Therapy Unit, Scientific Institute of Romagna, Meldola
RECRUITING
Medical Oncology and Immunotherapy Unit, University Hospital of Siena, Siena
NOT_YET_RECRUITING
"Medical Oncology, Cancer Institute Giovanni Paolo II", Bari
ACTIVE_NOT_RECRUITING
Medical Oncology and Innovative Therapy, National Cancer Institute, Naples
ACTIVE_NOT_RECRUITING
"Medical Oncology, National Cancer Institute Regina Elena", Rome
Collaborators (1)
Bristol-Myers Squibb
INDUSTRY
Italian Network for Tumor Biotherapy Foundation
OTHER