enfortumab vedotin (EV)

DRUG10 trials

Sponsors

Astellas Pharma Global Development, Inc., Merck Sharp & Dohme LLC, ImmunityBio, Inc., Generate Biomedicines, University of Florence

Conditions

Advanced Urothelial CancerAdvanced or Metastatic Breast Cancer (BC)Advanced or Metastatic Pancreatic AdenocarcinomaBladder CancerCarcinoma, Transitional CellLocally Advanced Urothelial CarcinomaLocally Advanced or Metastatic Urothelial Carcinoma (UC)Metastatic Urothelial Carcinoma

Phase 1

A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer

TerminatedNCT03288545

Astellas Pharma Global Development, Inc.Carcinoma, Transitional Cell, Renal Pelvis Neoplasms, Ureteral Neoplasms +4

Start: 2017-10-11End: 2026-02-20Updated: 2026-03-24

N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer

Not yet recruitingNCT07217496

ImmunityBio, Inc.Bladder Cancer, Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma +2

Start: 2026-12-01End: 2032-01-01Target: 18Updated: 2026-09-24

Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer

RecruitingNCT07484022

Generate BiomedicinesAdvanced Urothelial Cancer, Metastatic Urothelial Carcinoma

Start: 2026-06-08End: 2027-12-01Target: 37Updated: 2026-10-13

A Study of Dato-DXd in Participants With Solid Tumors [TROPION-PanTumor04 (TP04)]

RecruitingNCT07890714

Daiichi SankyoNon-small Cell Lung Cancer, Urothelial Cancer

Start: 2026-10-16End: 2030-01-31Target: 268Updated: 2026-10-22

Phase 2

EV + Toripalimab vs GC as Neoadjuvant Therapy in Locally Advanced/High-Risk MIBC

RecruitingNCT07647289

Peking University Third HospitalMuscle-Invasive Bladder Cancer (MIBC)

Start: 2025-04-15End: 2028-12-01Target: 58Updated: 2026-06-15

A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma

RecruitingNCT07815665

Summit TherapeuticsMetastatic Urothelial Carcinoma, Metastatic Urothelial Carcinoma (UC)

Start: 2026-09-10End: 2030-12-31Target: 800Updated: 2026-09-11

Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer

Not yet recruitingNCT07825753

Fudan UniversityAdvanced or Metastatic Breast Cancer (BC), Advanced or Metastatic Pancreatic Adenocarcinoma

Start: 2026-09-10End: 2030-02-01Target: 225Updated: 2026-09-17

Phase 3

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)

Active, not recruitingNCT04700124

Merck Sharp & Dohme LLCBladder Cancer

Start: 2021-04-21End: 2028-05-18Updated: 2026-07-16

Unknown Phase

An Expanded Access Treatment Protocol of Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma

Astellas Pharma Global Development, Inc.Locally Advanced or Metastatic Urothelial Carcinoma (UC)

Updated: 2020-01-13

Study of Peripheral Neuropathy in Patients With Advanced Urothelial Cancer Treated With Enfortumab Vedotin and Pembrolizumab With Supportive Neuridase (ENDEAVOR)

Not yet recruitingNCT07629700

University of FlorencePeripheral Nerve Disease, Urothelial Carcinoma (UC)

Start: 2026-09-01End: 2028-09-01Target: 40Updated: 2026-06-08

Related Papers

Neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab for participants with muscle-invasive bladder cancer who are eligible for cisplatin: Randomized, open-label, phase 3 KEYNOTE-B15 study.

Journal of Clinical Oncology2026-05-27

EV-103 dose escalation/cohort A: 5-year follow-up of enfortumab vedotin plus pembrolizumab in previously untreated locally advanced/metastatic urothelial carcinoma

ESMO Open2026-05-19

Study EV-103 cohort H: Neoadjuvant treatment with enfortumab vedotin (EV) monotherapy in cisplatin (cis)-ineligible patients (pts) with muscle invasive bladder cancer (MIBC)—3-year efficacy results.

Journal of Clinical Oncology2025-05-281 citations

Study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients with muscle invasive bladder cancer (MIBC)—2-year event-free survival and safety data for Cohort H.

Journal of Clinical Oncology2024-06-0111 citations

Managing potential adverse events during treatment with enfortumab vedotin + pembrolizumab in patients with advanced urothelial cancer

UNC Libraries2024-05-04

Managing potential adverse events during treatment with enfortumab vedotin + pembrolizumab in patients with advanced urothelial cancer

Frontiers in Oncology2024-04-2221 citations

FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma

Clinical Cancer Research2024-03-0515 citations

Sacituzumab Govitecan in Combination With Pembrolizumab for Patients With Metastatic Urothelial Cancer That Progressed After Platinum-Based Chemotherapy: TROPHY-U-01 Cohort 3

Journal of Clinical Oncology2024-01-2362 citations

Study EV-103 dose escalation/cohort A: Long-term outcome of enfortumab vedotin + pembrolizumab in first-line (1L) cisplatin-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC) with nearly 4 years of follow-up.

Journal of Clinical Oncology2023-06-0120 citations

Study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients (pts) with muscle invasive bladder cancer (MIBC): Updated results for Cohort H.

Journal of Clinical Oncology2023-06-0115 citations

Enfortumab vedotin (EV) with or without pembrolizumab (P) in patients (pts) who are cisplatin-ineligible with previously untreated locally advanced or metastatic urothelial cancer (la/mUC): Additional 3-month follow-up on cohort K data.

Journal of Clinical Oncology2023-06-017 citations

Perioperative enfortumab vedotin (EV) plus pembrolizumab (pembro) versus chemotherapy in cisplatin-eligible patients (pts) with muscle-invasive bladder cancer (MIBC): Phase 3 KEYNOTE-B15/EV-304.

Journal of Clinical Oncology2023-02-2018 citations

Patient-reported outcomes (PROs) in cisplatin-ineligible patients (pts) with locally advanced or metastatic urothelial cancer (la/mUC) treated with enfortumab vedotin (EV) alone or in combination with pembrolizumab (P) in the phase 1b/2 EV-103 Cohort K study.

Journal of Clinical Oncology2023-02-2018 citations

Enfortumab vedotin (EV) alone or in combination with pembrolizumab (P) in previously untreated cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer (la/mUC): Subgroup analyses of confirmed objective response rate (cORR) from EV-103 cohort K.

Journal of Clinical Oncology2023-02-2010 citations

Combination Therapy Shrinks Nearly All Tumors in Bladder Cancer Trial

Oncology Times2023-02-03

Study EV-103 Cohort H: Antitumor activity of neoadjuvant treatment with enfortumab vedotin monotherapy in patients with muscle-invasive bladder cancer who are cisplatin-ineligible.

Journal of Clinical Oncology2022-06-016 citations

Study EV-103 Cohort H: Antitumor activity of neoadjuvant treatment with enfortumab vedotin monotherapy in patients (pts) with muscle invasive bladder cancer (MIBC) who are cisplatin-ineligible.

Journal of Clinical Oncology2022-02-1626 citations

Study EV-103 cohort L: Evaluating perioperative enfortumab vedotin monotherapy in cis-ineligible muscle invasive bladder cancer (MIBC) (trial in progress).

Journal of Clinical Oncology2022-02-168 citations

Study EV-103: Update on durability results and long term outcome of enfortumab vedotin + pembrolizumab in first line locally advanced or metastatic urothelial carcinoma (la/mUC).

Journal of Clinical Oncology2021-05-2050 citations

KEYNOTE-B15/EV-304: Randomized phase 3 study of perioperative enfortumab vedotin plus pembrolizumab versus chemotherapy in cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC).

Journal of Clinical Oncology2021-05-2044 citations

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