{"id":"enfortumab-vedotin-ev","safety":{"commonSideEffects":[{"rate":"40-50%","effect":"Fatigue"},{"rate":"30-40%","effect":"Nausea"},{"rate":"20-30%","effect":"Diarrhea"},{"rate":"20-30%","effect":"Vomiting"},{"rate":"10-20%","effect":"Anemia"},{"rate":"10-20%","effect":"Thrombocytopenia"},{"rate":"10-20%","effect":"Neutropenia"},{"rate":"5-10%","effect":"Anorexia"},{"rate":"5-10%","effect":"Weight loss"},{"rate":"5-10%","effect":"Hypertension"}]},"_chembl":{"chemblId":"CHEMBL3301589","moleculeType":"Antibody drug conjugate"},"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"By binding to Nectin-4, enfortumab vedotin delivers a cytotoxic agent to cancer cells, leading to cell death. This targeted approach aims to minimize harm to healthy cells while maximizing the impact on cancer cells. Enfortumab vedotin has shown promise in treating certain types of cancer, including bladder and non-small cell lung cancer.","oneSentence":"Enfortumab vedotin is a monoclonal antibody-drug conjugate that targets Nectin-4, a protein highly expressed on the surface of certain cancer cells.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:10:52.785Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Locally advanced or metastatic urothelial cancer"},{"name":"Locally advanced or metastatic non-small cell lung cancer"}]},"trialDetails":[{"nctId":"NCT03288545","phase":"PHASE1, PHASE2","title":"A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer","status":"TERMINATED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2017-10-11","conditions":"Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Urologic Neoplasms","enrollment":348},{"nctId":"NCT07232602","phase":"PHASE1, PHASE2","title":"KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04)","status":"RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2026-02-09","conditions":"Bladder Cancer","enrollment":55},{"nctId":"NCT07484022","phase":"PHASE1","title":"Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer","status":"NOT_YET_RECRUITING","sponsor":"Generate Biomedicines","startDate":"2026-03","conditions":"Advanced Urothelial Cancer, Metastatic Urothelial Carcinoma","enrollment":37},{"nctId":"NCT05923190","phase":"PHASE2","title":"Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Fox Chase Cancer Center","startDate":"2023-06-14","conditions":"Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma","enrollment":60},{"nctId":"NCT07218380","phase":"PHASE3","title":"A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract","status":"RECRUITING","sponsor":"Eli Lilly and Company","startDate":"2025-12-12","conditions":"Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Neoplasm Metastasis","enrollment":450},{"nctId":"NCT07129993","phase":"PHASE2, PHASE3","title":"Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma","status":"RECRUITING","sponsor":"Daiichi Sankyo","startDate":"2025-09-26","conditions":"Urothelial Cancer, Bladder Cancer","enrollment":630},{"nctId":"NCT07217496","phase":"PHASE1","title":"N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer","status":"WITHDRAWN","sponsor":"Vadim S Koshkin","startDate":"2026-02-15","conditions":"Metastatic Urothelial Carcinoma, Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma","enrollment":""},{"nctId":"NCT03547973","phase":"PHASE2","title":"Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread","status":"RECRUITING","sponsor":"Gilead Sciences","startDate":"2018-08-13","conditions":"Metastatic Urothelial Cancer","enrollment":827},{"nctId":"NCT07468838","phase":"","title":"Feasibility Study of Urinary cfDNA Analysis as a Non-invasive Monitoring Tool in Patients With Prostate or Bladder Cancer","status":"NOT_YET_RECRUITING","sponsor":"Institut Cancerologie de l'Ouest","startDate":"2026-05","conditions":"Prostate Cancer, Bladder Cancer","enrollment":25},{"nctId":"NCT06862219","phase":"PHASE4","title":"A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer","status":"RECRUITING","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2025-06-21","conditions":"Metastatic Urothelial Carcinoma","enrollment":100},{"nctId":"NCT05239624","phase":"PHASE2","title":"Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer","status":"RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2022-06-02","conditions":"Urothelial Carcinoma","enrollment":23},{"nctId":"NCT07221942","phase":"PHASE2","title":"Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma","status":"RECRUITING","sponsor":"Fox Chase Cancer Center","startDate":"2026-01-23","conditions":"Metastatic Urothelial Carcinoma, Unresectable Urothelial Carcinoma, Advanced Urothelial Carcinoma","enrollment":97},{"nctId":"NCT07420855","phase":"","title":"International Multicentric Retrospective Study on the Use of EV+P as First-line Therapy in Patients With la/mUC","status":"NOT_YET_RECRUITING","sponsor":"Aron Research Foundation Ets","startDate":"2026-02","conditions":"Locally Advanced or Metastatic Urothelial Cancer, Urothelial Cancer","enrollment":361},{"nctId":"NCT06470282","phase":"PHASE1, PHASE2","title":"Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer","status":"RECRUITING","sponsor":"University of California, San Francisco","startDate":"2025-03-31","conditions":"Bladder Cancer, Muscle-Invasive Bladder Carcinoma, Stage II Bladder Cancer AJCC v8","enrollment":47},{"nctId":"NCT06483334","phase":"PHASE1, PHASE2","title":"A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2024-07-17","conditions":"Metastatic Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma","enrollment":38},{"nctId":"NCT06724159","phase":"","title":"Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.","status":"RECRUITING","sponsor":"Spanish Oncology Genito-Urinary Group","startDate":"2024-12-13","conditions":"Genitourinary Cancers","enrollment":500},{"nctId":"NCT04700124","phase":"PHASE3","title":"Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2021-04-21","conditions":"Bladder Cancer","enrollment":808},{"nctId":"NCT07183319","phase":"PHASE2","title":"Circulating Tumor DNA Response In Urothelial Cancer","status":"RECRUITING","sponsor":"University of Oklahoma","startDate":"2026-01-19","conditions":"Urothelial Carcinoma","enrollment":30},{"nctId":"NCT04878029","phase":"PHASE1","title":"Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer","status":"RECRUITING","sponsor":"Emory University","startDate":"2021-07-23","conditions":"Infiltrating Bladder Urothelial Carcinoma With Squamous Differentiation, Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma","enrollment":32},{"nctId":"NCT06041503","phase":"PHASE2","title":"Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE)","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2026-01-20","conditions":"Adenocarcinoma of the Bladder, Squamous Cell Carcinoma of the Bladder, Testicular Germ Cell Tumors","enrollment":68},{"nctId":"NCT03869190","phase":"PHASE1, PHASE2","title":"Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2019-06-01","conditions":"Urothelial Carcinoma, Bladder Cancer","enrollment":272},{"nctId":"NCT07139977","phase":"PHASE2","title":"Study of EV for Recurrent Endometrial Carcinoma","status":"NOT_YET_RECRUITING","sponsor":"William Bradley","startDate":"2026-04-01","conditions":"Endometrial Cancer","enrollment":12},{"nctId":"NCT07346053","phase":"PHASE3","title":"The Impact of Time-of-day Administration of EV/P on Objective Response Rate in Adults With Advanced Bladder Cancer","status":"NOT_YET_RECRUITING","sponsor":"Guliz Ozgun","startDate":"2026-05","conditions":"Advanced Bladder Cancer","enrollment":224},{"nctId":"NCT06305767","phase":"PHASE1, PHASE2","title":"A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2024-03-28","conditions":"Bladder Cancer","enrollment":230},{"nctId":"NCT03474107","phase":"PHASE3","title":"A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)","status":"COMPLETED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2018-06-27","conditions":"Ureteral Cancer, Urothelial Cancer, Bladder Cancer","enrollment":608},{"nctId":"NCT07087860","phase":"PHASE2","title":"Therapeutic Plasma Exchange With Enfortumab Vedotin and Pembrolizumab for Treatment of Bladder Cancers","status":"RECRUITING","sponsor":"Mayo Clinic","startDate":"2025-08-01","conditions":"Metastatic Bladder Urothelial Carcinoma, Metastatic Renal Pelvis and Ureter Urothelial Carcinoma, Refractory Bladder Urothelial Carcinoma","enrollment":70},{"nctId":"NCT07259226","phase":"PHASE2","title":"Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers","status":"RECRUITING","sponsor":"UNICANCER","startDate":"2025-11-14","conditions":"Advanced Breast Cancer, Advanced Gastric Cancer, Advanced Urothelial Cancer","enrollment":400},{"nctId":"NCT04724018","phase":"PHASE1, PHASE2","title":"Sacituzumab Govitecan Plus EV in Metastatic UC","status":"RECRUITING","sponsor":"Dana-Farber Cancer Institute","startDate":"2021-05-20","conditions":"Urothelial Cancer, Metastatic Urothelial Carcinoma, Metastatic Urothelial Carcinoma of the Renal Pelvis and Ureter","enrollment":106},{"nctId":"NCT06394570","phase":"PHASE1, PHASE2","title":"Enfortumab Vedotin and Stereotactic Radiation for Localized, Cisplatin Ineligible Muscle Invasive Bladder Cancer","status":"RECRUITING","sponsor":"University of Texas Southwestern Medical Center","startDate":"2024-09-10","conditions":"Bladder Cancer","enrollment":19},{"nctId":"NCT05845814","phase":"PHASE1, PHASE2","title":"A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2023-06-23","conditions":"Metastatic Urothelial Carcinoma, Urothelial Neoplasms","enrollment":390},{"nctId":"NCT06302569","phase":"PHASE2","title":"Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma","status":"RECRUITING","sponsor":"Giuseppe Procopio","startDate":"2025-05-30","conditions":"Bellini Carcinoma, Collecting Duct Carcinoma, Renal Medullary Carcinoma","enrollment":23},{"nctId":"NCT05879653","phase":"PHASE2","title":"Pembrolizumab and EV With Radiation Therapy for MIBC Patients (PEVRAD)","status":"RECRUITING","sponsor":"Kyoto University Hospital","startDate":"2023-10-01","conditions":"Bladder Cancer","enrollment":30},{"nctId":"NCT03924895","phase":"PHASE3","title":"Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2019-07-24","conditions":"Urinary Bladder Cancer, Muscle-invasive","enrollment":595},{"nctId":"NCT05756569","phase":"PHASE2","title":"Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology","status":"RECRUITING","sponsor":"Emory University","startDate":"2023-09-26","conditions":"Bladder Squamous Cell Carcinoma, Locally Advanced Bladder Carcinoma, Malignant Renal Pelvis Neoplasm","enrollment":25},{"nctId":"NCT07072637","phase":"","title":"Neurological Function in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With Enfortumab Vedotin-Based Therapy","status":"NOT_YET_RECRUITING","sponsor":"National Taiwan University Hospital","startDate":"2025-07","conditions":"Locally Advanced or Metastatic Urothelial Carcinoma","enrollment":100},{"nctId":"NCT07063758","phase":"","title":"A Biomarker Study to Predict Treatment Outcomes of Enfortumab Vedotin in Advanced Urothelial Carcinoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Taiwan University Clinical Trial Center","startDate":"2025-04-01","conditions":"Advanced Urothelial Carcinoma","enrollment":200},{"nctId":"NCT06493552","phase":"PHASE2, PHASE3","title":"Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors","status":"RECRUITING","sponsor":"Vasgene Therapeutics, Inc","startDate":"2025-03-15","conditions":"Muscle-Invasive Bladder Carcinoma, Metastatic Urothelial Carcinoma","enrollment":700},{"nctId":"NCT06682845","phase":"","title":"Association Between Drug-related Cutaneous Adverse Events and Progression Free Survival in Patients Treated with Enfortumab Vedotin","status":"COMPLETED","sponsor":"Hospices Civils de Lyon","startDate":"2024-05-02","conditions":"Cutaneous Adverse","enrollment":22},{"nctId":"NCT04136808","phase":"","title":"An Expanded Access Treatment Protocol of Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma","status":"APPROVED_FOR_MARKETING","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"","conditions":"Locally Advanced or Metastatic Urothelial Carcinoma (UC)","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["ASG-22CE","Padcev","ASG-22ME","PADCEV","Enfortumab Vedotin"],"phase":"phase_3","status":"active","brandName":"enfortumab vedotin (EV)","genericName":"enfortumab vedotin (EV)","companyName":"Astellas Pharma Global Development, Inc.","companyId":"astellas-pharma-global-development-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Enfortumab vedotin is a monoclonal antibody-drug conjugate that targets Nectin-4, a protein highly expressed on the surface of certain cancer cells. Used for Locally advanced or metastatic urothelial cancer, Locally advanced or metastatic non-small cell lung cancer.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}