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Background: Clinical trials have shon that nivolumab and the combination of nivolumab and ipilimumab improve response rates and progression-free survival PFS compared ith ipilimumab in pts ith metastatic melanoma, hoever pts ith active brain metastases ere excluded. We sought to determine the antitumour activity and safety of nivolumab and nivolumab combined ith ipilimumab in pts ith active melanoma brain metastases NCT02374242 . Methods: This open-label, multisite ph 2 study consists of 3 cohorts. Cohorts 1 n = 30 and 3 n = 30 include pts ith active melanoma brain metastases ith no prior local therapy to the brain and are asymptomatic from the brain metastases. Eligible pts are randomised to either cohort 1: nivolumab only 3mgkg Q2W or cohort 3: nivolumab 1mgkg Q3W x 4, then 3mgkg Q2W combined ith ipilimumab 3mgkg Q3W x 4 . Cohort 2 n = 16 includes pts ith brain metastases ho have either 1 failed local therapy ith evidence of intracranial progression ne +- progressed in previously treated lesions , 2 neurological symptoms related to brain metastases or 3 leptomeningeal disease. Pts ith prior treatment ith anti-PD1PDL1PDL2CTLA4 therapies are excluded. Pts must have 1 brain metastasis that measure 5mm and x2264; 40mm as per RECIST 1.1 by MRI + gadolinium. FET-PET is performed at baseline, k 6 and k 12. MRI brain and extracranial CT scans are performed at baseline, 6 kly until k 24, and 12 kly thereafter. The primary endpoint is the best intracranial response k 12. Secondary endpoints include best extracranial response, best overall response, intracranial PFS, extracranial PFS, overall PFS and overall survival, as ell as safety and tolerability. Cohort 2 completed enrolment in May 2015. 18 and 15 pts have been enrolled in cohort 1 and 3 respectively as of Jan 2015. The data, safety and monitoring board revieed the study in Dec 2015 and recommended the trial continue as planned. Recruitment is expected to be complete by Oct 2016. Thereafter, an additional to cohorts of nivolumab combined ith stereotactic radiosurgery x2264; 4 brain metastases or hole brain radiotherapy 5 brain metastases ill be recruited. Clinical trial information: lta href=http:clinicaltrials.govshoNCT02374242 NCT02374242,J Clin Oncol 34, 2016 suppl; abstr TPS9591 ,NCT02374242,00:00.0,MelanomaSkin Cancers
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