Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 23, 2026
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Phase 2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT04225117). This is a study registration, not published results. Lead sponsor: Astellas Pharma Global Development, Inc.. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 329 participants (ACTUAL). Conditions: Locally Advanced or Metastatic Malignant Solid Tumors. Interventions: DRUG: enfortumab vedotin; DRUG: pembrolizumab. Primary outcome measures: 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 , Up to 20.04 months; Cohort 9: Confirmed ORR (CR and PR) Per RECIST V1.1 Per Investigator Assessment , Up to 12.85 months. Brief summary: The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per RECIST v1.1. This study will also assess other measures of antitumor activity; overall survival (OS); as well as the safety and tolerability of enfortumab vedotin for cohorts 1 to 8 and enfortumab vedotin + pembrolizumab in cohort 9.