FORAGER-2: A randomized phase 3 study evaluating the efficacy and safety of vepugratinib combined with enfortumab vedotin and pembrolizumab in untreated locally advanced or metastatic urothelial carcinoma with an FGFR3 genetic alteration.
To evaluate the efficacy and safety of combining vepugratinib with enfortumab vedotin and pembrolizumab in patients with FGFR3-altered urothelial carcinoma.
Randomized, double-blind, placebo-controlled phase 3 study design.
450 patients with untreated metastatic urothelial carcinoma harboring FGFR3 mutations will be randomized.
Participants receive either enfortumab vedotin/pembrolizumab plus vepugratinib or placebo.
Evaluations include progression-free survival, overall survival, and safety.
Primary endpoint is progression-free survival assessed by independent review.
Key secondary endpoints cover overall survival and objective response rates.
Combination therapy has a favorable safety profile based on earlier studies.