Pal, SumantaSomford, Diederik M.Grivas, PetrosSridhar, Srikala S.Gupta, ShilpaBellmunt Molins, Joaquim, 1959-Sonpavde, GuruFleming, Mark T.Lerner, Seth PaulLoriot, YohannHoffman-Censits, JeanValderrama, Begoña P.Andresen, CorinaSchnabel, Marco J.Cole, SuzanneDaneshmand, Siamak2023-02-152023-02-152022Pal SK, Somford DM, Grivas P, Sridhar SS, Gupta S, Bellmunt J, et al. Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial. Future Oncol. 2022 Jul; 18(21): 2599-614. DOI: 10.2217/fon-2021-16291479-6694http://hdl.handle.net/10230/55778PROOF 302 is an ongoing randomized, double-blind, placebo-controlled, adjuvant phase III trial (NCT04197986) in approximately 218 patients from 120 centers worldwide. Eligibility criteria include post-surgical high-risk muscle-invasive upper tract urothelial cancer (85% of patients) or urothelial bladder cancer (15%), susceptible FGFR3 alterations (activating mutations, gene fusions or rearrangements), ≤120 days following radical surgery and ineligible for/or refusing cisplatin-based (neo)adjuvant chemotherapy. Patients receive either oral infigratinib 125 mg or placebo daily on days 1-21 of a 28-day cycle for up to 52 weeks or until recurrence, unacceptable toxicity or death. Primary end point: centrally determined disease-free survival (DFS); secondary end points: investigator-assessed DFS, metastasis-free survival, overall survival and safety/tolerability; exploratory end points: correlative biomarker analysis, quality-of-life and infigratinib pharmacokinetics.application/pdfengThis work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/articlehttp://dx.doi.org/10.2217/fon-2021-1629FGFR inhibitorFGFR3PROOF 302Adjuvant cisplatin-based chemotherapyAdjuvant therapyCisplatin-therapy refusalFusions or rearrangementsInfigratinibMuscle-invasive urothelial carcinomaMutationsNeoadjuvant cisplatin-based chemotherapyPhase IIIUpper tract urothelial carcinomaUrothelial bladder carcinomaUrothelial carcinomainfo:eu-repo/semantics/openAccess