Skip to main content

enfortumab vedotin

Generic: enfortumab·Brand: Padcev

enfortumab vedotin: 34 clinical trials tracked.

enfortumab vedotin evidence translation

What we can confirm

34 tracked trials

No verified listed company relationship

What it means

AI will separate confirmed drug evidence from unknown company context.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

What is verified about enfortumab vedotin, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence8 indications · 6 study sponsors
Clinical Trial Registry Records (34)showing 10 most recent

Open-Label, Single-Arm, Phase 1b Clinical Trial of NAI Plus Pembrolizumab With Short Course of Enfortumab Vedotin in Treatment-Naïve Participants With Metastatic Urothelial Carcinoma

NCT07217496Registry updated 2026-09-24·Phase 1·IBRX
Not yet recruiting

Primary endpoint: Assess the safety and tolerability of the treatment regimen (NAI, EV, and pembrolizumab).

Interventionalopen18 targetStarted 2026-12Completion 2032-011 site · United StatesImmunityBio, Inc.

A Phase Ib/II Study to Evaluate the Safety and Efficacy of Enfortumab Vedotin Plus Pembrolizumab in Combination With Quemliclustat in Unresectable Locally Advanced and Metastatic Urothelial Carcinoma

NCT07667335Registry updated 2026-09-30·Phase 1/Phase 2
Recruiting

Primary endpoint: Incidence of treatment related adverse events (Phase Ib)

Interventionalopen27 targetStarted 2026-10Completion 2029-071 site · United StatesFred Hutchinson Cancer Center

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)

NCT07815665Registry updated 2026-09-11·Phase 2/Phase 3·SMMT
Recruiting

Primary endpoint: Phase 2 Primary Outcome Measure

InterventionalRandomizedopen800 targetStarted 2026-09Completion 2030-127 sites · United StatesSummit Therapeutics

A Phase 2 Study to Assess Efficacy of Induction Enfortumab Vedotin Plus Pembrolizumab Using a Response-adapted Approach to Spare the Bladder: FIDELIO

NCT07663747Registry updated 2026-06-25·Phase 2
Not yet recruiting

Primary endpoint: Estimated 2-year bladder-intact event-free survival (BI-EFS) for the intention-to-treat population, measured from day 1 of treatment until the moment of analysis

InterventionalRandomizedopen56 targetStarted 2026-09Completion 2032-043 sites · NetherlandsThe Netherlands Cancer Institute

A Phase III, Open-Label, Randomised, Multicentre, Global Study of Adjuvant Datopotamab Deruxtecan in Combination With Rilvegostomig in Participants With High-risk Muscle Invasive Urothelial Carcinoma

NCT07720284Registry updated 2026-07-22·Phase 3·AZN
Recruiting

Primary endpoint: To demonstrate the superiority of Dato-DXd + rilvegostomig (Arm 1) relative to SoC (Arm 3) by assessment of disease-free survival (DFS) (based on Investigator assessments).

InterventionalRandomizedsingle915 targetStarted 2026-07Completion 2032-1150 sites · Australia, Brazil, Canada, China…AstraZeneca

A Phase 1, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of GB-4362 Administered With Enfortumab Vedotin and Pembrolizumab in Participants With Advanced Urothelial Cancer

NCT07484022Registry updated 2026-06-18·Phase 1·GENB
Recruiting

Primary endpoint: Incidence of AEs and SAEs

Interventionalopen37 targetStarted 2026-06Completion 2027-1210 sites · United StatesGenerate Biomedicines

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

NCT07566156Registry updated 2026-09-30·Phase 3
Recruiting

Primary endpoint: Bladder-intact Event Free Survival (BI-EFS) by Blinded Independent Central Review (BICR)

InterventionalRandomizedopen390 targetStarted 2026-05Completion 2032-0219 sites · Canada, South Korea, Taiwan, United StatesAstellas Pharma Global Development, Inc.

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)

NCT07475806Registry updated 2026-09-24·Phase 2
Recruiting

Primary endpoint: Overall clinical complete response (cCR) rate after treatment with enfortumab vedotin in combination with pembrolizumab as assessed by investigator

Interventionalopen240 targetStarted 2026-03Completion 2031-0448 sites · Australia, France, Germany, Japan…Astellas Pharma Global Development, Inc.

AN INTERVENTIONAL PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, ANTITUMOR ACTIVITY, AND PHARMACOKINETICS OF PF 08634404 MONOTHERAPY OR IN COMBINATION WITH ENFORTUMAB VEDOTIN IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER

NCT07421700Registry updated 2026-09-28·Phase 1/Phase 2·PFE
Recruiting

Primary endpoint: Confirmed Objective Response Rate (ORR) by investigator

Interventionalopen132 targetStarted 2026-03Completion 2028-09173 sites · Australia, China, Japan, Puerto Rico…Pfizer

Pembrolizumab Maintenance After Enfortumab Vedotin/Pembrolizumab Induction in Front-Line Metastatic Urothelial Carcinoma

NCT07221942Registry updated 2026-02-19·Phase 2
Recruiting

Primary endpoint: 18-month progression-free survival (PFS)

Interventionalopen97 targetStarted 2026-01Completion 2029-091 site · United StatesFox Chase Cancer Center