2026-04-13T12:35:35Zhttps://recercat.cat/oai/request
oai:recercat.cat:10230/557782025-12-24T08:48:14Zcom_2072_6col_2072_452952
RECERCAT author Pal, Sumanta author Somford, Diederik M. author Grivas, Petros author Sridhar, Srikala S. author Gupta, Shilpa author Bellmunt Molins, Joaquim, 1959- author Sonpavde, Guru author Fleming, Mark T. author Lerner, Seth Paul author Loriot, Yohann author Hoffman-Censits, Jean author Valderrama, Begoña P. author Andresen, Corina author Schnabel, Marco J. author Cole, Suzanne author Daneshmand, Siamak 2023-02-15T07:29:12Z2023-02-15T07:29:12Z2022 PROOF 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. This 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/ http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess FGFR inhibitor FGFR3 PROOF 302 Adjuvant cisplatin-based chemotherapy Adjuvant therapy Cisplatin-therapy refusal Fusions or rearrangements Infigratinib Muscle-invasive urothelial carcinoma Mutations Neoadjuvant cisplatin-based chemotherapy Phase III Upper tract urothelial carcinoma Urothelial bladder carcinoma Urothelial carcinoma Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion