A phase II, open label, randomized controlled trial of nivolumab plus ipilimumab with stereotactic radiotherapy versus ipilimumab plus nivolumab alone in patients with melanoma brain metastases (ABC -X Trial).
Maria Gonzalez, Angela M Hong, Matteo S Carlino, Victoria Atkinson, Wei Wang, Serigne Lo, Michael Paul Brown, Matthew C Foote, Mark B Pinkham, Hien Le, Daniel E Roos, Monica Osorio, Neda Haghighi, David Kok, Michael A Postow, Grant A McArthur, Alexander M Menzies, Georgina V Long
JOURNAL OF CLINICAL ONCOLOGY | AMER SOC CLINICAL ONCOLOGY | Published : 2019
TPS9600 Background: Nivolumab combined with ipilimumab is active in melanoma brain metastases, with intracranial response rates > 55% and durable survival in treatment naïve patients (pts) (Long GV et al Lancet Onc 2018; Tawbi H et al NEJM 2018). We seek to determine if the addition of stereotactic radiotherapy (SRS) results in improved intracranial outcomes. Methods: This is a multisite, open-label, phase 2 trial in systemic treatment-naïve pts with melanoma brain metastases. Pts must have ≥1 asymptomatic brain metastases that are ≥5mm and ≤40mm as per modified RECIST 1.1, on gadolinium-enhanced MRI, and no history of previous treatment with SRS. Eligible pts are randomly assigned to eithe..View full abstract