{"entity":{"id":"nct04225117","kind":"trial","name":"A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)","aka":[],"tldr":"A phase 2 trial of Enfortumab vedotin and Pembrolizumab in advanced solid tumours, run by Astellas Pharma Global Development, Inc., active and no longer recruiting.","summary":"A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202) is a phase 2 interventional study registered as NCT04225117 by Astellas Pharma Global Development, Inc., with 329 participants enrolled, started 2020-03-10 and due to reach its primary completion in 2025-02-25. Interventions recorded: enfortumab vedotin and pembrolizumab. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04225117","url":"https://clinicaltrials.gov/study/NCT04225117"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["enfortumab-vedotin","pembrolizumab"],"companies":["astellas","pfizer","merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04225117","phase":"2","setting":"An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)","sponsor":"Astellas Pharma Global Development, Inc.","started":"2020-03-10","startedType":"actual","yearReported":2026,"enrolled":329,"enrolledBasis":"registry","outcomes":[{"endpoint":"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","primary":true,"unit":"%","arms":[{"name":"Cohort 1: HR+/HER2- Breast Cancer","n":45,"value":15.6,"note":"95% CI 6.49 to 29.46; Figures from the ClinicalTrials.gov results section (first posted 2026-04-13), not from a publication"},{"name":"Cohort 2: TNBC Cancer","n":42,"value":19,"note":"95% CI 8.60 to 34.12"},{"name":"Cohort 3: Squamous NSCLC","n":23,"value":4.3,"note":"95% CI 0.11 to 21.95"},{"name":"Cohort 4: Non-squamous NSCLC","n":43,"value":16.3,"note":"95% CI 6.81 to 30.70"},{"name":"Cohort 5: Head and Neck Cancer","n":46,"value":23.9,"note":"95% CI 12.59 to 38.77"},{"name":"Cohort 7: EAC","n":42,"value":9.5,"note":"95% CI 2.66 to 22.62"},{"name":"Cohort 8: ESCC","n":44,"value":18.2,"note":"95% CI 8.19 to 32.71"}],"source":"https://clinicaltrials.gov/study/NCT04225117?tab=results"},{"endpoint":"Cohort 9: Confirmed ORR (CR and PR) Per RECIST V1.1 Per Investigator Assessment","primary":true,"unit":"%","arms":[{"name":"Cohort 9: HNSCC","n":41,"value":39,"note":"95% CI 24.20 to 55.50; Figures from the ClinicalTrials.gov results section (first posted 2026-04-13), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04225117?tab=results"}]},"route":"/trials/nct04225117/","neighbours":{"cancer":[{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"}],"drug":[{"id":"enfortumab-vedotin","kind":"drug","name":"Enfortumab vedotin","route":"/drugs/enfortumab-vedotin/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"astellas","kind":"company","name":"Astellas","route":"/companies/astellas/"},{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"},{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}]}}