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A Phase II Study of Nivolumab and Nivolumab Combined With Ipilimumab in Patients With Melanoma Brain Metastases
Australia and New Zealand Melanoma Trials Group (ANZMTG)
Initially, this study will recruit patients with melanoma brain metastases who have received no prior local treatment for their intracranial metastatic disease and who are asymptomatic (Cohort 1) and in parallel, patients who have been previously treated for their brain metastases, have symptoms, or have concurrent leptomeningeal disease (Cohort 2) will be enrolled to receive nivolumab monotherapy (3mg/kg).
A third group of patients with brain metastases who have received no prior treatment for their metastatic disease and who are asymptomatic to receive combined nivolumab 1 mg/kg and ipilimumab 3mg/kg (Cohort 3) every 3 weeks for 4 doses, then continuing on nivolumab monotherapy per cohorts 1 and 2.
Recruitment to cohort 3 will commence once the first 6 patients from cohort 1 have received at least 6 doses of study treatment (equivalent to 12 weeks) and have a satisfactory adverse event record. After this safety assessment, patients will continue to be recruited to this cohort. To minimise bias, treatment allocation to cohort 3 and the remainder of cohort 1 will be assigned by unequal randomisation ratio to achieve an overall balance of 30 patients receiving nivolumab 3 mg/kg (including the 6 patients from cohort 1) and 30 patients receiving the combination treatment.
Allocation concealment for Cohort 1 and 3 will be performed through central randomisation.