Clinical trial · no report yet · Phase 3
EV-302
Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
- NCT04223856 ↗
- Active not recruiting
- Astellas Pharma Global Development, Inc.
- 853 commentary sources found
- Deep
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.
| Channel | Found | |
|---|---|---|
| X threads | 454 | |
| YouTube | 203 | |
| Podcasts | 186 | |
| X videos | 10 |
The trial
ClinicalTrials.gov- Official title
- An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
- Phase
- Phase 3
- Status
- Active not recruiting
- Conditions
- Urothelial Cancer
- Interventions
- Enfortumab vedotin; Pembrolizumab; Cisplatin; Carboplatin; Gemcitabine
- Arms
- Arm A · Experimental
- Arm B · Active comparator
- Enrollment
- 886
- Primary outcomes
- Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Blinded Independent Central Review (BICR)
- Overall Survival (OS)
- Sponsor
- Astellas Pharma Global Development, Inc. with Merck Sharp & Dohme LLC, Seagen Inc.
- Start
- Mar 30, 2020
- Primary completion
- Aug 8, 2023
- Results posted
- Yes
- Registry record
- NCT04223856 · updated May 29, 2026
Publications
linked from the registry- Gupta S, Loriot Y, Van der Heijden MS, Bedke J, Valderrama BP, Kikuchi E, Flechon A, Petrylak D, De Santis M, Galsky MD, Lee JL, Swami U, Sridhar SS, De Giorgi U, Wright P, Shih V, Lu YT, Guan X, Dillon R, Shetty A, Homet Moreno B, Beaumont JL, Purnajo I, McManus S, Powles T. How enfortumab vedotin plus pembrolizumab affects the quality of life of people with advanced urothelial cancer compared with platinum-based chemotherapy: a plain language summary of patient-reported outcomes from the EV-302 study. Future Oncol. 2026 Apr;22(9):1015-1029. doi: 10.1080/14796694.2026.2645984. Epub 2026 Apr 2. PubMed 41925239
- Kikuchi E, Van der Heijden MS, Valderrama BP, Gupta S, Bedke J, Shin SJ, Li JR, Guo J, Danchaivijitr P, Kanesvaran R, Park SH, Su WP, Kandori S, Bae WK, Wong A, Gorla S, Bavle A, Yu X, Lu YT, Powles T. Pan-Asian subgroup analysis of EV-302/KEYNOTE-A39: a phase 3 study to evaluate enfortumab vedotin and pembrolizumab in patients with untreated advanced urothelial carcinoma. Int J Clin Oncol. 2026 Mar;31(3):436-446. doi: 10.1007/s10147-025-02950-8. Epub 2026 Jan 21. PubMed 41563650
- Meng Y, Zhang S, Aout M, Babcock A, Li H, Lai Y, Brand-Wiita S, Notinger S, Bavle A, Mamtani R. Cost-effectiveness of enfortumab vedotin plus pembrolizumab as a first-line treatment of locally advanced or metastatic urothelial carcinoma in the United States. J Med Econ. 2025 Dec;28(1):1779-1797. doi: 10.1080/13696998.2025.2567190. Epub 2025 Oct 14. PubMed 41039930
- Gupta S, Loriot Y, Van der Heijden MS, Bedke J, Valderrama BP, Kikuchi E, Flechon A, Petrylak D, De Santis M, Galsky MD, Lee JL, Swami U, Sridhar SS, De Giorgi U, Wright P, Shih V, Lu YT, Guan X, Dillon R, Shetty A, Moreno BH, Beaumont JL, Purnajo I, McManus S, Powles T. Enfortumab vedotin plus pembrolizumab versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (EV-302): patient-reported outcomes from an open-label, randomised, controlled, phase 3 study. Lancet Oncol. 2025 Jun;26(6):795-805. doi: 10.1016/S1470-2045(25)00158-5. PubMed 40449498
- Benjamin DJ, Rezazadeh Kalebasty A, Prasad V. The Overall Survival Benefit in EV-302: Is Enfortumab Vedotin plus Pembrolizumab the New Frontline Standard of Care for Metastatic Urothelial Carcinoma? Eur Urol Oncol. 2024 Jun;7(3):313-315. doi: 10.1016/j.euo.2024.02.010. Epub 2024 Mar 13. PubMed 38485615
- Niegisch G. Enfortumab Vedotin and Pembrolizumab - A New Perspective on Urothelial Cancer. N Engl J Med. 2024 Mar 7;390(10):944-946. doi: 10.1056/NEJMe2400311. No abstract available. PubMed 38446680
- Powles T, Valderrama BP, Gupta S, Bedke J, Kikuchi E, Hoffman-Censits J, Iyer G, Vulsteke C, Park SH, Shin SJ, Castellano D, Fornarini G, Li JR, Gumus M, Mar N, Loriot Y, Flechon A, Duran I, Drakaki A, Narayanan S, Yu X, Gorla S, Homet Moreno B, van der Heijden MS; EV-302 Trial Investigators. Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer. N Engl J Med. 2024 Mar 7;390(10):875-888. doi: 10.1056/NEJMoa2312117. PubMed 38446675
- Hoimes CJ, Flaig TW, Milowsky MI, Friedlander TW, Bilen MA, Gupta S, Srinivas S, Merchan JR, McKay RR, Petrylak DP, Sasse C, Moreno BH, Yu Y, Carret AS, Rosenberg JE. Enfortumab Vedotin Plus Pembrolizumab in Previously Untreated Advanced Urothelial Cancer. J Clin Oncol. 2023 Jan 1;41(1):22-31. doi: 10.1200/JCO.22.01643. Epub 2022 Aug 30. PubMed 36041086