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

Sponsor
Italian Network for Tumor Biotherapy Foundation
Study ID
NCT02460068
Phase
PHASE3
Status
Unknown

Conditions

  • Brain Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fotemustine — DRUG
    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 — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 31, 2012
Status verified
May 2015
Primary completion
Jan 31, 2018
Completion
Jan 31, 2020

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: fotemustine
    fotemustine alone
  • Experimental: fotemustine and ipilimumab
    fotemustine in combination with ipilimumab
  • Experimental: ipilimumab and nivolumab
    ipilimumab in combination with nivolumab

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: 2 years ]

Central Contacts

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