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
-

Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study

First Posted Date
2021-05-14
Last Posted Date
2024-06-21
Lead Sponsor
Mirati Therapeutics Inc.
Target Recruit Count
55
Registration Number
NCT04887870
Locations
🇺🇸

Local Institution - 516-014-004, Columbus, Ohio, United States

🇺🇸

Local Institution - 516-014-011, Albany, New York, United States

🇺🇸

Local Institution - 516-014-027, Fairfax, Virginia, United States

and more 10 locations

Enfortumab Vedotin as Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer

First Posted Date
2021-02-15
Last Posted Date
2024-07-03
Lead Sponsor
University of Utah
Target Recruit Count
34
Registration Number
NCT04754191
Locations
🇺🇸

Huntsman Cancer Institute, Salt Lake City, Utah, United States

A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

First Posted Date
2020-01-13
Last Posted Date
2024-12-09
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
320
Registration Number
NCT04225117
Locations
🇯🇵

Site JP81004, Nagoya, Aichi, Japan

🇯🇵

Site JP81001, Kashiwa, Chiba, Japan

🇯🇵

Site JP81005, Chuo-ku, Osaka, Japan

and more 34 locations

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

First Posted Date
2020-01-10
Last Posted Date
2024-07-26
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
1030
Registration Number
NCT04223856
Locations
🇺🇸

Hillman Cancer Center / University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

🇯🇵

Site JP81006, Kawasaki-shi, Japan

🇨🇳

Site CN86025, Hefei, China

and more 257 locations

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)

First Posted Date
2019-04-23
Last Posted Date
2024-10-14
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
857
Registration Number
NCT03924895
Locations
🇨🇦

Princess Margaret Cancer Centre ( Site 0107), Toronto, Ontario, Canada

🇺🇸

University of Chicago ( Site 0068), Chicago, Illinois, United States

🇪🇸

Hospital Universitario San Carlos ( Site 0678), Madrid, Spain

and more 239 locations

Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

First Posted Date
2019-03-11
Last Posted Date
2024-08-26
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
645
Registration Number
NCT03869190
Locations
🇪🇸

START Madrid. Centro Integral Oncologico Clara Campal; CIOCC, Madrid, Spain

🇪🇸

Hospital Clinico Universitario de Valencia, Valencia, Spain

🇨🇳

National Taiwan University Hospital, Yun-Lin Branch, Huwei Township, Taiwan

and more 38 locations

A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma

First Posted Date
2018-07-30
Last Posted Date
2023-08-24
Lead Sponsor
Mirati Therapeutics Inc.
Target Recruit Count
260
Registration Number
NCT03606174
Locations
🇺🇸

University of California Irvine, Irvine, California, United States

🇺🇸

The University of Arizona Cancer Center, Tucson, Arizona, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

and more 33 locations

Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread

First Posted Date
2018-06-06
Last Posted Date
2024-12-11
Lead Sponsor
Gilead Sciences
Target Recruit Count
643
Registration Number
NCT03547973
Locations
🇺🇸

The University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States

🇺🇸

USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States

🇺🇸

University of California San Francisco, San Francisco, California, United States

and more 132 locations

A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

First Posted Date
2018-03-22
Last Posted Date
2024-11-20
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
608
Registration Number
NCT03474107
Locations
🇺🇸

University of Pennsylvania, Philadelphia, Pennsylvania, United States

🇧🇪

Site BE32013, Brussels, Belgium

🇧🇪

Site BE32001, Gent, Belgium

and more 155 locations
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