Clinical trial · no report yet · Phase 2
KEYNOTE-F21
A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
- NCT04225117 ↗
- Active, not recruiting
- Astellas Pharma Global Development, Inc.
- Standard
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.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| X threads | 9 | |
| YouTube | 4 | |
| Podcasts | 4 |
The trial
ClinicalTrials.gov- 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)
- Phase
- Phase 2
- Status
- Active, not recruiting
- Conditions
- Locally Advanced or Metastatic Malignant Solid Tumors
- Interventions
- enfortumab vedotin; pembrolizumab
- Arms
- Cohort 1: HR+/HER2- breast cancer · Experimental
- Cohort 2: Triple negative breast cancer (TNBC) · Experimental
- Cohort 3: Squamous non-small cell lung cancer · Experimental
- Cohort 4: Non-squamous non-small cell lung cancer · Experimental
- Cohort 5: Head and neck cancer · Experimental
- Cohort 6: Gastric or GEJ or esophageal cancer · Experimental
- Cohort 7: Gastric and esophageal adenocarcinoma (EAC) including GEJ adenocarcinoma · Experimental
- Cohort 8: Esophageal squamous cell carcinoma (ESCC) · Experimental
- Cohort 9: Head and neck squamous cell carcinoma (HNSCC) · Experimental
- Enrollment
- 329
- Primary outcomes
- 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
- Cohort 9: Confirmed ORR (CR and PR) Per RECIST V1.1 Per Investigator Assessment
- Sponsor
- Astellas Pharma Global Development, Inc. with Seagen Inc., Merck Sharp & Dohme LLC
- Start
- Mar 10, 2020
- Primary completion
- Feb 25, 2025
- Results posted
- Yes
- Registry record
- NCT04225117 · updated Sep 23, 2026
Publications
linked from the registry- 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. PubMed 40819431
- 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. PubMed 39481054
- 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. PubMed 41135379