Genomically matched therapy in advanced solid tumors: the randomized phase 2 ROME trial.

ABSTRACT: Despite recent advancements demonstrating the potential of tumor-agnostic biomarkers to guide effective therapies, randomized evidence supporting the clinical superiority of precision oncology approaches compared to standard therapies remains limited. The ROME trial was a multicenter, randomized, open-label phase 2 study comparing tailored treatment (TT) to standard of care (SoC) in patients with advanced solid tumors progressing after one or two lines of therapy. Comprehensive genomic profiling on tissue and blood was performed to identify actionable alterations. Overall response rate (ORR) was the primary endpoint, and progression-free survival (PFS), overall survival (OS), time to treatment failure (TTF), time to next treatment (TTNT) and safety were the secondary endpoints. Between Nov

SUBMITTER: Marchetti P 

PROVIDER: S-EPMC12532583 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature