Padcev 30 mg powder for concentrate for solution for infusion
Sponsors
Seagen Inc., Astrazeneca AB, Gilead Sciences Inc., Grupo Espanol Multidisciplinar De Melanoma, Grupo Espanol De Tumores Neuroendocrinos
Conditions
Adult patients with cT2-4aN0-1 urothelial bladder cancerAdvanced MelanomaBladder CancerLocally Advanced or Metastatic Urothelial CancerLocally Advanced or Metastatic Urothelial CarcinomaLocally Advanced/Metastatic Urothelial CancerMuscle-Invasive Bladder CancerMuscle-invasive Bladder Cancer
Phase 1
Phase 2
C5701002/SGN22E-002 - A study of enfortumab vedotin (ASG-22CE) as monotherapy or in combination with other anticancer therapies for the treatment of urothelial cancer
Active, not recruitingCTIS2023-503391-24-00
Start: 2021-05-26Target: 7Updated: 2026-01-19
A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer
RecruitingCTIS2023-508302-24-00
Start: 2019-05-07Target: 116Updated: 2025-10-22
Multicenter, open label, single arm, phase II study to assess the efficay and safety of enfortumab-vedotin (EV) as a single agent in patients with advanced Neuroendocrine Carcinomas (NEC) refractory or ineligible to platinum-containing chemotherapy
RecruitingCTIS2024-515511-21-00
Start: 2025-03-13Target: 63Updated: 2025-10-29
A Phase II, Open-Label, Multicenter, Non-Randomized Study Of The Efficacy And Safety Of Enfortumab Vedotin In Combination With Pembrolizumab Previously Treated
Advanced Melanoma
RecruitingCTIS2024-514163-26-00
Start: 2025-06-09Target: 60Updated: 2025-03-18
DEPECA-1 – DEfeating PEnile CAncer 1 – A Phase II study to evaluate a first-line systemic therapy with enfortumab vedotin plus avelumab for advanced and metastatic penile carcinoma
RecruitingCTIS2025-521644-37-00
Start: 2025-11-28Target: 25Updated: 2025-10-29
An Open-label, Single-Arm, Phase 2 Study to Evaluate Enfortumab Vedotin plus Pembrolizumab for Bladder Preservation in Participants with Muscle-invasive Bladder Cancer (EV-209).
Not yet recruitingCTIS2025-524488-18-00
Target: 78Updated: 2026-06-23
A Randomized Phase 2/3 Study of Ivonescimab in Combination with Enfortumab Vedotin vs Pembrolizumab in Combination with Enfortumab Vedotin in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma (HARMONi GU1)
Not yet recruitingCTIS2026-525831-17-00
Target: 15Updated: 2026-09-21
A phase 2 study to assess efficacy of induction Enfortumab Vedotin plus Pembrolizumab using a response-adapted approach to spare the bladder: FIDELIO
Not yet recruitingCTIS2026-525965-29-00
Target: 56Updated: 2026-10-05
Phase 3
C5701003 - An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer
Active, not recruitingCTIS2023-503421-19-00
Start: 2020-08-26Target: 703Updated: 2025-08-19
A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)
Active, not recruitingCTIS2023-507342-84-00
Start: 2021-10-26Target: 284Updated: 2025-10-28
C5701009 - A Phase 3, Open-label, Randomized Study To Evaluate Enfortumab Vedotin in Combination with Pembrolizumab in Adult participants with Muscle-Invasive Bladder Cancer Who Are Ineligible for or have elected not to undergo cystectomy
Not yet recruitingCTIS2026-525612-34-00
Target: 88Updated: 2026-10-16