CheckMate 915
Research type
Research Study
Full title
A Phase 3, Randomized Study of Adjuvant Immunotherapy with Nivolumab Combined with Ipilimumab Versus Nivolumab Monotherapy after Complete Resection of Stage IIIb/c/d or Stage IV Melanoma.
IRAS ID
222659
Contact name
Paul Lorigan
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2016-003729-41
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
This is a multicentre, phase 3 study involving investigational drugs called nivolumab and ipilimumab, in patients at least 15 years old following complete resection of Stage III or Stage IV melanoma. Approximately 1125 patients will take part globally, 47 of these will be in the UK. The study is sponsored by Bristol Myers Squibb. \n \nTreatment for melanoma includes removal of the tumour and sometimes lymph nodes. Systemic therapy may be given in cases where the melanoma has been fully resected but is at high risk of returning, this is called adjuvant treatment. The purpose of this study is to find out if treatment with the combination of nivolumab and ipilimumab will improve outcomes for patients when compared to either nivolumab or ipilimumab alone when given as adjuvant therapy for melanoma. \n\nFollowing a screening period, eligible patients will be randomly assigned to receive either nivolumab or ipilimumab or both. This is a double blind study, so subjects and doctors will not know what treatment is assigned and placebos will be used to maintain the blind. All medications are given intravenously (through a vein). Patients will be treated for up to one year or until disease recurrence or unacceptable toxicity. Throughout the study, patients will undergo the following procedures: CT, MRI and or PET scans, physical exams and vital signs, blood sampling and pregnancy testing. They will also be asked to complete questionnaires at regular intervals. Follow-up visits will continue after completion of study treatment.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
17/SW/0078
Date of REC Opinion
30 May 2017
REC opinion
Further Information Favourable Opinion