Discussion
HGG, tumor
ROAR, DISEASE, TUMOR, SOLID TUMOR
To our knowledge, ROAR is the first prospective study of a combination treatment approach with The ROAR study included patients with advanced disease, and all patients had received pre-treatment with standard-of-care therapies. This reduced the risk of observing an inflated ORR. In this study, we deployed an adaptive design for ORR with a Bayesian hierarchical model to increase the power to identify clinically meaningful outcomes. This helped to identify cohorts that could be further expanded and allowed for multiple interim data evaluations to determine if a histologic cohort should discontinue enrollment early due to success or futility. The ATC, BTC, HGG and HCL cohorts were stopped early for efficacy, and an expansion cohort was opened for each of these cohorts. None of the cohorts was stopped early due to futility. Additional strengths of the study design included the analysis of ORR with standard frequentist estimates for each of the cohorts and an independent radiology review for solid tumor cohorts.In line with available evidence in earlier studiesThe ROAR study supports a tumor-agnostic approach to The results of the ROAR study further corroborate those of subprotocol H (EAY131-H) of the NCI-MATCH platform trial, which included 35 patients (primary efficacy analysis in 29 patients) with The median DoR in included tumor cohorts in our study ranged from 31.2 months to NR and was higher when compared to the DoR reported in the NCI-MATCH study, which was 25.1 months (90% CI: 12.8, NR)The findings from the ROAR study are also complementary to available case reports supporting the efficacy of dabrafenib plus trametinib in various In a phase 2 trial (ClinicalTrials.gov identifier: Figure 