Enfortumab vedotin

Generic Name: Enfortumab vedotin

Brand Names: Padcev

Drug Type: Biotech

Chemical Formula: -

CAS Number: 1346452-25-2

Unique Ingredient Identifier: DLE8519RWM

Background: Enfortumab vedotin is an antibody-drug conjugate used in the treatment of patients with advanced, treatment-resistant urothelial cancers. It is comprised of a fully human monoclonal antibody targeted against Nectin-4 and a microtubule-disrupting chemotherapeutic agent, monomethyl auristatin E (MMAE), joined by a protease-cleavable link. It is similar to bren...

Indication: Enfortumab vedotin is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting. Enfortumab vedoti...

Associated Conditions: Locally Advanced Urothelial Cancer, Locally Advanced or Metastatic Urothelial Carcinoma (UC), Metastatic Urothelial Cancer

Associated Therapies: -

Clinical Trials

A Study of Enfortumab Vedotin in People with Urothelial Carcinoma of the Upper Urinary Tract

Phase 2

Recruiting

Conditions: Urothelial Carcinoma

Interventions: Drug: Enfortumab Vedotin
Procedure: Radical surgery

First Posted Date: 2023-05-22

Last Posted Date: 2024-10-28

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 24

Registration Number: NCT05868265

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States

and more 4 locations

Pembrolizumab and Enfortumab Vedotin With Pembrolizumab Prior to and After Radical Nephroureterectomy for High-Risk Upper Tract Urothelial Cancer

Phase 2

Not yet recruiting

Conditions: Renal Pelvis and Ureter Urothelial Carcinoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Drug: Enfortumab Vedotin
Procedure: MR Urography
Procedure: Nephroureterectomy
Biological: Pembrolizumab

First Posted Date: 2023-03-20

Last Posted Date: 2024-06-24

Lead Sponsor: Jonsson Comprehensive Cancer Center

Target Recruit Count: 21

Registration Number: NCT05775471

Locations: 🇺🇸
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology

Phase 2

Recruiting

Conditions: Malignant Ureter Neoplasm
Stage III Bladder Cancer AJCC v8
Urachal Adenocarcinoma
Malignant Urethral Neoplasm
Metastatic Bladder Carcinoma
Locally Advanced Bladder Carcinoma
Malignant Renal Pelvis Neoplasm
Unresectable Bladder Carcinoma
Bladder Squamous Cell Carcinoma
Stage IV Bladder Cancer AJCC v8

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Enfortumab Vedotin
Procedure: Magnetic Resonance Imaging
Biological: Pembrolizumab
Other: Questionnaire Administration

First Posted Date: 2023-03-06

Last Posted Date: 2024-06-10

Lead Sponsor: Emory University

Target Recruit Count: 25

Registration Number: NCT05756569

Locations: 🇺🇸
Grady Health System, Atlanta, Georgia, United States
🇺🇸
Emory University Hospital Midtown, Atlanta, Georgia, United States
🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

and more 1 locations

Renal Retention in High Grade Upper Tract Urothelial Cancer

Phase 2

Recruiting

Conditions: Bladder Cancer
Urothelial Carcinoma Bladder
High Grade Urothelial Carcinoma

Interventions: Drug: Enfortumab vedotin
Drug: Pembrolizumab

First Posted Date: 2022-12-19

Last Posted Date: 2024-12-11

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 20

Registration Number: NCT05656235

Locations: 🇺🇸
Johns Hopkins University: Sibley Memorial Hospital, Washington, District of Columbia, United States
🇺🇸
Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07)

Phase 1

Recruiting

Conditions: Bladder Cancer
Urothelial Carcinoma

Interventions: Drug: Evorpacept
Drug: Enfortumab Vedotin

First Posted Date: 2022-09-01

Last Posted Date: 2024-03-22

Lead Sponsor: ALX Oncology Inc.

Target Recruit Count: 30

Registration Number: NCT05524545

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
University of North Carolina, Chapel Hill, North Carolina, United States
🇺🇸
Oregon Health & Science University, Portland, Oregon, United States

and more 6 locations

Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer

Phase 2

Recruiting

Conditions: Urothelial Carcinoma

Interventions: Drug: Enfortumab vedotin
Drug: Pembrolizumab

First Posted Date: 2022-02-15

Last Posted Date: 2024-07-18

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 23

Registration Number: NCT05239624

Locations: 🇺🇸
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Westchester, Harrison, New York, United States
🇺🇸
University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, United States

and more 7 locations

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Phase 1

Recruiting

Conditions: Urinary Bladder Neoplasms
NMIBC
Carcinoma Transitional Cell
Non-muscle Invasive Bladder Cancer
Carcinoma in Situ

Interventions: Drug: Enfortumab vedotin

First Posted Date: 2021-08-20

Last Posted Date: 2024-10-21

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 58

Registration Number: NCT05014139

Locations: 🇺🇸
Mayo Clinic, Scottsdale, Arizona, United States
🇺🇸
UCLA Department of Medicine - Hematology & Oncology, Los Angeles, California, United States
🇺🇸
James Cancer Hospital / Ohio State University, Columbus, Ohio, United States

and more 29 locations

A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and Programmed Cell Death Protein-1 ( PD 1) / (Programmed Death Ligand-1 (PD-L1) Inhibitor Therapy

Phase 2

Active, not recruiting

Conditions: Metastatic Urothelial Cancer

Interventions: Drug: Enfortumab vedotin

First Posted Date: 2021-08-09

Last Posted Date: 2024-12-16

Lead Sponsor: Astellas Pharma China, Inc.

Target Recruit Count: 40

Registration Number: NCT04995419

Locations: 🇨🇳
Site CN86002, Guangzhou, China
🇨🇳
Site CN86004, Shanghai, China
🇨🇳
Site CN86001, Beijing, China

and more 4 locations

Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy

Phase 1

Recruiting

Conditions: Locally Advanced Bladder Urothelial Carcinoma
Locally Advanced Urethral Urothelial Carcinoma
Locally Advanced Urothelial Carcinoma
Metastatic Bladder Urothelial Carcinoma
Locally Advanced Renal Pelvis Urothelial Carcinoma
Locally Advanced Ureter Urothelial Carcinoma
Metastatic Renal Pelvis Urothelial Carcinoma
Metastatic Ureter Urothelial Carcinoma
Metastatic Urothelial Carcinoma
Stage IIIB Bladder Cancer AJCC v8

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Scan
Procedure: Computed Tomography
Procedure: Echocardiography
Drug: Enfortumab Vedotin
Drug: Erdafitinib
Procedure: Multigated Acquisition Scan

First Posted Date: 2021-07-15

Last Posted Date: 2024-12-18

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 30

Registration Number: NCT04963153

Locations: 🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
UCHealth University of Colorado Hospital, Aurora, Colorado, United States

and more 6 locations

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

Phase 3

Recruiting

Conditions: Muscle Invasive Bladder Cancer

Interventions: Drug: Durvalumab
Drug: Tremelimumab
Drug: Enfortumab Vedotin
Procedure: Radical Cystectomy

First Posted Date: 2021-07-14

Last Posted Date: 2024-12-03

Lead Sponsor: AstraZeneca

Target Recruit Count: 677

Registration Number: NCT04960709

Locations: 🇻🇳
Research Site, Hue, Vietnam

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