{"commentary":{"count":7,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":7},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":false},"name":"NCT04164901","nct_id":"NCT04164901","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04164901. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Vorasidenib 40 mg, continuous daily dosing.","label":"Vorasidenib","type":"EXPERIMENTAL"},{"description":"Matching placebo 40 mg, continuous daily dosing.","label":"Matching Placebo","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2028-05","type":"ESTIMATED"},"conditions":["Grade 2 Glioma","Residual Glioma","Recurrent Glioma"],"enrollment":{"count":331,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Vorasidenib","type":"DRUG"},{"name":"Matching Placebo","type":"DRUG"}],"last_update":"2025-04-03","lead_sponsor":"Institut de Recherches Internationales Servier","official_title":"A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of AG-881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2022-09-06","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-Free Survival (PFS)","timeFrame":"Up to approximately 30 months"}],"references":[{"citation":"Mellinghoff IK, van den Bent MJ, Blumenthal DT, Touat M, Peters KB, Clarke J, Mendez J, Yust-Katz S, Welsh L, Mason WP, Ducray F, Umemura Y, Nabors B, Holdhoff M, Hottinger AF, Arakawa Y, Sepulveda JM, Wick W, Soffietti R, Perry JR, Giglio P, de la Fuente M, Maher EA, Schoenfeld S, Zhao D, Pandya SS, Steelman L, Hassan I, Wen PY, Cloughesy TF; INDIGO Trial Investigators. Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma. N Engl J Med. 2023 Aug 17;389(7):589-601. doi: 10.1056/NEJMoa2304194. Epub 2023 Jun 4.","pmid":"37272516","type":"RESULT"},{"citation":"Cloughesy TF, van den Bent MJ, Touat M, Blumenthal DT, Peters KB, Ellingson BM, Clarke JL, Mendez J, Yust-Katz S, Welsh L, Mason WP, Ducray F, Umemura Y, Nabors B, Holdhoff M, Hottinger AF, Arakawa Y, Sepulveda JM, Wick W, Soffietti R, Perry J, Giglio P, de la Fuente M, Maher E, Bottomley A, Tron AE, Yi D, Zhao D, Pandya SS, Steelman L, Hassan I, Wen PY, Mellinghoff IK; INDIGO trial investigators. Vorasidenib in IDH1-mutant or IDH2-mutant low-grade glioma (INDIGO): secondary and exploratory endpoints from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2025 Dec;26(12):1665-1675. doi: 10.1016/S1470-2045(25)00472-3. Epub 2025 Oct 29.","pmid":"41175888","type":"DERIVED"}],"start_date":{"date":"2020-01-05","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)","url":"https://clinicaltrials.gov/study/NCT04164901"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct04164901"}