{"preliminary_commentary":{"by_channel":{"x_thread":9,"youtube":4,"podcast":4},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04225117\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"name":"KEYNOTE-F21","nct_id":"NCT04225117","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-f21-nct04225117. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.\n\nHR+/HER2- = Hormone receptor-positive/ human epidermal growth factor receptor 2-negative","label":"Cohort 1: HR+/HER2- breast cancer","type":"EXPERIMENTAL"},{"description":"Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.","label":"Cohort 2: Triple negative breast cancer (TNBC)","type":"EXPERIMENTAL"},{"description":"Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.","label":"Cohort 3: Squamous non-small cell lung cancer","type":"EXPERIMENTAL"},{"description":"Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.","label":"Cohort 4: Non-squamous non-small cell lung cancer","type":"EXPERIMENTAL"},{"description":"Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.","label":"Cohort 5: Head and neck cancer","type":"EXPERIMENTAL"},{"description":"Participants enrolled into Cohort 6 will be reallocated based on disease type and histology into Cohorts 7 or 8.\n\nGEJ= gastroesophageal junction","label":"Cohort 6: Gastric or GEJ or esophageal cancer","type":"EXPERIMENTAL"},{"description":"Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.","label":"Cohort 7: Gastric and esophageal adenocarcinoma (EAC) including GEJ adenocarcinoma","type":"EXPERIMENTAL"},{"description":"Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.","label":"Cohort 8: Esophageal squamous cell carcinoma (ESCC)","type":"EXPERIMENTAL"},{"description":"Participants will receive enfortumab vedotin as an IV infusion on days 1 and 8 of each 21-day cycle. Pembrolizumab will be administered as an IV infusion on day 1 of each 21-day cycle.","label":"Cohort 9: Head and neck squamous cell carcinoma (HNSCC)","type":"EXPERIMENTAL"}],"collaborators":["Seagen Inc.","Merck Sharp & Dohme LLC"],"completion_date":{"date":"2027-03-31","type":"ESTIMATED"},"conditions":["Locally Advanced or Metastatic Malignant Solid Tumors"],"enrollment":{"count":329,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"enfortumab vedotin","otherNames":["ASG-22CE"],"type":"DRUG"},{"name":"pembrolizumab","otherNames":["KEYTRUDA®"],"type":"DRUG"}],"last_update":"2026-09-23","lead_sponsor":"Astellas Pharma Global Development, Inc.","official_title":"An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2025-02-25","type":"ACTUAL"},"primary_outcomes":[{"measure":"Cohorts 1-8: Confirmed Overall Response Rate (ORR) (Complete Response [CR] and Partial Response [PR]) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (V)1.1 Per Investigator Assessment","timeFrame":"Up to 20.04 months"},{"measure":"Cohort 9: Confirmed ORR (CR and PR) Per RECIST V1.1 Per Investigator Assessment","timeFrame":"Up to 12.85 months"}],"references":[{"citation":"Muro K, Feinstein T, Baranda J, Bonta I, Yanagitani N, Gersten T, Gandhi L, Kudo T, Fujioka N, Kaplan J, Gorla S, Liu S, Wozniak M, Poondru S, Dillon R, Meng C, Patil T. Enfortumab vedotin in patients with advanced non-small cell lung cancer after disease progression on platinum- and PD-1/PD-L1 inhibitor-containing regimens: Phase 2 international multicenter EV-202 study. Eur J Cancer. 2025 Sep 9;227:115603. doi: 10.1016/j.ejca.2025.115603. Epub 2025 Jul 9.","pmid":"40819431","type":"RESULT"},{"citation":"Swiecicki PL, Yilmaz E, Rosenberg AJ, Fujisawa T, Bruce JY, Meng C, Wozniak M, Zhao Y, Mihm M, Kaplan J, Gorla S, Geiger JL. Phase II Trial of Enfortumab Vedotin in Patients With Previously Treated Advanced Head and Neck Cancer. J Clin Oncol. 2025 Feb 10;43(5):578-588. doi: 10.1200/JCO.24.00646. Epub 2024 Oct 31.","pmid":"39481054","type":"RESULT"},{"citation":"Muro K, Chin K, Maron SB, Braiteh FS, Mitani S, Hara H, Kuboki Y, Mulcahy MF, Baranda JC, Gardner FP, Jin N, Hamauchi S, Kaplan J, Gorla S, Liu S, Wozniak M, Poondru S, Dillon R, Meng C, Kondo S. Phase II trial of enfortumab vedotin in patients with previously treated gastric and esophageal cancers. ESMO Open. 2025 Nov;10(11):105806. doi: 10.1016/j.esmoop.2025.105806. Epub 2025 Oct 23.","pmid":"41135379","type":"RESULT"}],"start_date":{"date":"2020-03-10","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)","url":"https://clinicaltrials.gov/study/NCT04225117"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/keynote-f21-nct04225117"}