Pal, Sumanta KSomford, Diederik MGrivas, PetrosSridhar, Srikala SGupta, ShilpaBellmunt, JoaquimSonpavde, GuruFleming, Mark TLerner, Seth PLoriot, YohannHoffman-Censits, JeanValderrama, Begoña PAndresen, CorinaSchnabel, Marco JCole, SuzanneDaneshmand, Siamak2023-05-032023-05-032022-05-24http://hdl.handle.net/10668/20492PROOF 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.enAttribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/FGFR inhibitorFGFR3PROOF 302adjuvant cisplatin-based chemotherapyadjuvant therapycisplatin-therapy refusalfusions or rearrangementsinfigratinibmuscle-invasive urothelial carcinomamutationsneoadjuvant cisplatin-based chemotherapyphase IIIupper tract urothelial carcinomaurothelial bladder carcinomaurothelial carcinomaAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Transitional CellChemotherapy, AdjuvantHumansPhenylurea CompoundsPyrimidinesRandomized Controlled Trials as TopicReceptor, Fibroblast Growth Factor, Type 3Urinary Bladder Neoplasmsresearch article35608106open access10.2217/fon-2021-16291744-8301https://doi.org/10.2217/fon-2021-1629