EV-301
A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
- NCT03474107 ↗
- Completed
- Astellas Pharma Global Development, Inc.
- Deep
We haven't built an HCP commentary report on EV-301 (enfortumab vedotin, vinflunine and 2 more in Ureteral Cancer) 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.
Questions raised in the commentary
Automated, Oct 29, 2026. Not an Erudio report: no source links. Not medical advice.
Discussion covers post-hoc analyses of enfortumab vedotin exposure and dose modification, including the relationship between early exposure, response, and subsequent dose reductions or holds. It considers whether starting-dose intensity and later changes in exposure may influence outcomes, and examines dose-related analyses in EV-301. Commentary also addresses health-related quality-of-life domains, including pain, appetite, and neuropathy, and raises the need for predictive biomarkers such as NECTIN4.
Indexed commentary on EV-301 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 48 | |
| Podcasts | 44 | |
| YouTube | 40 | |
| X videos | 3 | |
| Bluesky threads | 2 |
The trial
ClinicalTrials.gov- Official title
- An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
- Phase
- Phase 3
- Status
- Completed
- Conditions
- Ureteral Cancer; Urothelial Cancer; Bladder Cancer
- Interventions
- Enfortumab Vedotin; Docetaxel; Vinflunine; Paclitaxel
- Arms
- Arm A: Enfortumab Vedotin 1.25 mg/kg · Experimental
- Arm B: Chemotherapy · Active comparator
- Cross-over Extension (COE) · Experimental
- Enrollment
- 608
- Primary outcomes
- Overall Survival (OS)
- Sponsor
- Astellas Pharma Global Development, Inc. with Seagen Inc.
- Start
- Jun 27, 2018
- Primary completion
- Jul 15, 2020
- Results posted
- Yes
- Registry record
- NCT03474107 · updated Jan 9, 2026
Publications
linked from the registry- Rosenberg JE, Mamtani R, Sonpavde GP, Loriot Y, Duran I, Lee JL, Matsubara N, Vulsteke C, Castellano D, Sridhar SS, Pappot H, Gurney H, Bedke J, van der Heijden MS, Galli L, Keam B, Masumori N, Meran J, O'Donnell PH, Park SH, Grande E, Sengelov L, Uemura H, Skaltsa K, Campbell M, Matsangou M, Wu C, Hepp Z, McKay C, Powles T, Petrylak DP. Health-related Quality of Life in Patients with Previously Treated Advanced Urothelial Carcinoma from EV-301: A Phase 3 Trial of Enfortumab Vedotin Versus Chemotherapy. Eur Urol. 2024 Jun;85(6):574-585. doi: 10.1016/j.eururo.2024.01.007. Epub 2024 Feb 28. PubMed 38418343
- Powles T, Rosenberg JE, Sonpavde GP, Loriot Y, Duran I, Lee JL, Matsubara N, Vulsteke C, Castellano D, Wu C, Campbell M, Matsangou M, Petrylak DP. Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma. N Engl J Med. 2021 Mar 25;384(12):1125-1135. doi: 10.1056/NEJMoa2035807. Epub 2021 Feb 12. PubMed 33577729