Enfortumab Vedotin (Padcev)
Treatment for Bladder Cancer
Typical Dosage: 1.25 mg/kg IV on days 1, 8, and 15 of a 28-day cycle
Effectiveness
70%
Safety Score
40%
Clinical Trials
19
Participants
2K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
40
DangerousModerateSafe
Treatment Details
Dosage Range
1.25 mg/kg IV on days 1, 8, and 15 of a 28-day cycle
Time to Effect
1-3 months
Treatment Duration
Lifetime (or until progression)
Evidence Quality
HIGHNumber Needed to Treat (NNT)
4(Treat 4 patients to see 1 additional successful outcome)
Number Needed to Harm (NNH)
3(Treat 3 patients to see 1 additional serious adverse event)
Confidence Score
90%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$320,000
Monitoring:$7,500
Side Effect Mgmt:$10,000
Total Annual:$337,500
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
POORICER
$250,000/QALY
QALYs Gained
0.8
Outcome-Based Costs
Cost per Responder
$750,000
Cost per Remission
$2,812,500
Comparison vs Taxane chemotherapy (e.g., Docetaxel)
Cost Difference
+$250,000/year
More expensive
QALY Difference
+0.50 QALYs
Better outcomes
Dominance
No dominance
Enfortumab Vedotin (Padcev) Outcomes
for Bladder Cancer
Efficacy Outcomes
Overall Effectiveness
+70%
Response Rate
+45%
Remission Rate
+12%
Common Side Effects
Fatigue
+55%
Peripheral neuropathy
+45%
Rash/Skin reactions
+45%
Hyperglycemia
+15%
Active Clinical Trials
16 active trials recruiting for Enfortumab Vedotin (Padcev) in Bladder Cancer
Enfortumab Vedotin and Stereotactic Radiation for Localized, Cisplatin Ineligible Muscle Invasive Bladder Cancer
NCT06394570RECRUITINGPHASE1, PHASE2
19 participants
INTERVENTIONAL
Dallas, United States
Started: Sep 10, 2024
A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection
NCT06011954RECRUITING
202 participants
OBSERVATIONAL
Goyang-si, South Korea +17 more
Started: Nov 1, 2023
Renal Retention in High Grade Upper Tract Urothelial Cancer
NCT05656235RECRUITINGPHASE2
20 participants
INTERVENTIONAL
Washington D.C., United States +1 more
Started: Nov 25, 2024
Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin
NCT04960709ACTIVE NOT RECRUITINGPHASE3
712 participants
INTERVENTIONAL
Orange, United States +201 more
Started: Aug 5, 2021
A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer
NCT03288545ACTIVE NOT RECRUITINGPHASE1, PHASE2
348 participants
INTERVENTIONAL
Anchorage, United States +105 more
Started: Oct 11, 2017
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)
NCT03924895ACTIVE NOT RECRUITINGPHASE3
595 participants
INTERVENTIONAL
Mobile, United States +241 more
Started: Jul 24, 2019
Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors
NCT06493552RECRUITINGPHASE2, PHASE3
700 participants
INTERVENTIONAL
Santa Monica, United States
Started: Mar 15, 2025
A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)
NCT06305767RECRUITINGPHASE1, PHASE2
230 participants
INTERVENTIONAL
Los Angeles, United States +73 more
Started: Mar 28, 2024
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)
NCT04700124ACTIVE NOT RECRUITINGPHASE3
808 participants
INTERVENTIONAL
Phoenix, United States +187 more
Started: Apr 21, 2021
Sacituzumab Govitecan Plus EV in Metastatic UC
NCT04724018RECRUITINGPHASE1, PHASE2
106 participants
INTERVENTIONAL
Boston, United States
Started: May 20, 2021
Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer
NCT06470282RECRUITINGPHASE1, PHASE2
47 participants
INTERVENTIONAL
San Francisco, United States
Started: Mar 31, 2025
Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology
NCT05756569RECRUITINGPHASE2
25 participants
INTERVENTIONAL
Atlanta, United States +3 more
Started: Sep 26, 2023
Cabozantinib in Combination with Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer
NCT04878029RECRUITINGPHASE1
32 participants
INTERVENTIONAL
Atlanta, United States
Started: Jul 23, 2021
Therapeutic Plasma Exchange With Enfortumab Vedotin and Pembrolizumab for Treatment of Bladder Cancers
NCT07087860RECRUITINGPHASE2
70 participants
INTERVENTIONAL
Rochester, United States
Started: Aug 1, 2025
Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy
NCT04963153ACTIVE NOT RECRUITINGPHASE1
30 participants
INTERVENTIONAL
Los Angeles, United States +9 more
Started: Jul 7, 2022
Enfortumab Vedotin and Pembrolizumab With Cystectomy and/or Ureterectomy for Locally Advanced or Metastatic Bladder and Upper Urothelial Tract Cancer, CAST-AI Trial
NCT06764095RECRUITINGPHASE4
75 participants
INTERVENTIONAL
Rochester, United States
Started: Jan 8, 2025
Completed Clinical Trials
1 completed trial for Enfortumab Vedotin (Padcev) in Bladder Cancer
A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07)
NCT05524545COMPLETEDPHASE1
36 participants
INTERVENTIONAL
Tampa, United States +7 more
Started: Nov 2, 2022