CA209-511 Nivolumab with Ipilimumab in Subjects with Melanoma
Research type
Research Study
Full title
Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination with Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination with Ipilimumab 3 mg/kg in Subjects with Previously Untreated, Unresectable or Metastatic Melanoma
IRAS ID
198815
Contact name
Mark Middleton
Contact email
Sponsor organisation
Bristol-Myers Squibb
Eudract number
2015-004920-67
Duration of Study in the UK
5 years, 9 months, 24 days
Research summary
This is a multicentre, phase 3 study involving a combination of 2 investigational drugs nivolumab and Ipilimumab in treatment naïve metastatic melanoma subjects (≥ 18 years).
The purpose of this study is to compare the rate of drug-related Grade 3 - 5 Adverse Events resulting from the treatment with nivolumab 3 mg/kg/ipilimumab 1 mg/kg (ARM A) versus nivolumab 1 mg/kg/ipilimumab 3 mg/kg (ARM B).
Published data in advanced melanoma using the combination of nivolumab 1 mg/kg/ipilimumab 3 mg/kg reported improved efficacy compared to either monotherapy. However, the combination doses tested showed increased toxicity compared to either single agent. This study will test if changing the doses of the combination will reduce the rate of drug related Grade 3-5 Adverse Events and have similar efficacy.
Approximately 460 patients will take part globally with approximately 345 patients treated (at least 25 subjects coming from the UK). The study is sponsored by Bristol Myers Squibb.
After screening, eligible patients will receive 4 doses of either the ARM A or ARM B combination of nivolumab and ipilimumab, followed by a 480mg flat dose of nivolumab every 4 weeks.
This is a double blind study, so subjects and doctors will not know which treatment arm subjects have been assigned to. All medications are given through a vein.
Patients will undergo the following study procedures:
CT/MRI scans,
Physical exams,
Vital signs,
Blood sampling for routine safety and study specific testing.
Pregnancy testing
Participants will complete questionnaires at regular intervals throughout the study.
The subjects will be treated until unacceptable toxicity, disease progression or subject withdraws consent. The expected duration of the study from start of randomization to primary analysis is approximately 12 months. Additional survival follow-up may continue for up to 5 years from the primary analysis. The study will end once survival follow-up has concluded.REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0137
Date of REC Opinion
6 May 2016
REC opinion
Further Information Favourable Opinion