MK-3475 compared to Ipilimumab in Patients with Advanced Melanoma
Research type
Research Study
Full title
A Multicenter, Randomized, Controlled, Three-Arm, Phase III Study to Evaluate the Safety and Efficacy of Two Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Patients with Advanced Melanoma
IRAS ID
122809
Contact name
James Larkin
Sponsor organisation
Merck Sharp & Dohme Ltd
Eudract number
2012-004907-10
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Malignant Melanoma is the 5th most common cancer in the UK (2010). In 2010, 12,818 people were diagnosed with 2,203 deaths from malignant melanoma.Ipilimumab (IPI) is regarded as standard of care in patients with unresectable or advanced melanoma treated with other therapies (second line indication).Not all patients respond to current therapies and there is a need for new treatments.This is a randomised, controlled, open-label, two-arm pivotal study of MK-3475 versus IPI in patients with unresectable or metastatic melanoma who have not received prior IPI treatment. Patients will be randomised to MK-3475 or IPI in a 1:1 ratio.Patients randomised to the MK-3475 arm will receive MK-3475 as an IV infusion at 10mg/kg once every 3 weeks until disease progression, intolerable toxicity, or withdrawal of consent. Patient randomised to IPI arm will receive IPI at 3mg/kg as an IV infusion once every 3 weeks for a total of 4 doses (per the current label). After the baseline tumour evaluation, tumour assessments during the study will be performed by radiological scans at Weeks 12, 18, 24 and every 12 weeks thereafter for patients who have not progressed. The primary endpoint is overall survival. The study will enrol approximately 480 patients of which 45 are expected to be enrolled from the UKs 7 potential study sites.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
13/SC/0096
Date of REC Opinion
1 Mar 2013
REC opinion
Favourable Opinion