Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer (EV-302)

June 4, 2025 updated by: Astellas Pharma Global Development, Inc.

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

This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.

Study Overview

Status

Active, not recruiting

Conditions

Urothelial Cancer

Intervention / Treatment

Detailed Description

Japan PMDA has approved enfortumab vedotin (Padcev) for the treatment of advanced urothelial cancer. The study will continue as a post marketing study in Japan.

This study is being conducted to evaluate the combination of enfortumab vedotin + pembrolizumab versus standard of care gemcitabine + platinum-containing chemotherapy, in subjects with previously untreated locally advanced or metastatic urothelial cancer.

Enfortumab vedotin may be administered for an unlimited number of cycles until a protocol defined reason for study discontinuation occurs. Pembrolizumab may be administered for a maximum of 35 cycles or a protocol-defined reason for study discontinuation occurs, whichever is first. Cisplatin or carboplatin plus gemcitabine may be administered for a maximum of 6 cycles or a protocol-defined reason for study discontinuation occurs, whichever is first.

Study Type

Interventional

Enrollment (Actual)

886

Phase

Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aire, Argentina, C1019ABS
    - Site AR54008
  - Caba, Argentina, C1426ANZ
    - Site AR54011
  - Cordoba, Argentina, X5004FHP
    - Site AR54005
  - La Rioja, Argentina, 5300
    - Site AR54006
  - Mendoza, Argentina, M5500AYB
    - Site AR54004
  - Rosario, Argentina, 2000
    - Site AR54001
  - San Miguel, Argentina, T400GTB
    - Site AR54002
  - Tucuman, Argentina, T4000IAK
    - Site AR54012
  - Viedma, Argentina, 8500
    - Site AR54003
Australia
- - Box Hill, Australia, 3128
    - Site AU61003
  - Douglas, Australia, 4814
    - Site AUS61001
  - Heidelberg, Australia, 3084
    - Site AUS61004
  - Macquarie Park, Australia, 2109
    - Site AUS61002
  - South Australia, Australia, 5112
    - Site AUS61006
  - South Brisbane, Australia, 4101
    - Site AU61005
Belgium
- - Brussels, Belgium, 1200
    - Site BE32003
  - Ghent, Belgium, 9000
    - Site BE32002
  - Liege, Belgium, 4000
    - Site BE32001
  - Lueven, Belgium, 3000
    - Site BE32007
  - Roeselare, Belgium, 8800
    - Site BE32006
Canada
- - Quebec, Canada, G1R 2J6
    - Site CA11008
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Site CA11004
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Site CA11003
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 4E6
    - Site CA11006
- Ontario
  - Hamilton, Ontario, Canada, L8V 1C3
    - Site CA11002
  - London, Ontario, Canada, N6A 5A5
    - Site CA11009
  - Oshawa, Ontario, Canada, L1G 2B9
    - Site CA11011
  - Toronto, Ontario, Canada, M4N 3M5
    - Site CA11012
  - Toronto, Ontario, Canada, M5G 2M9
    - Site CA11005
- Quebec
  - Montreal, Quebec, Canada, H2X 0A9
    - Site CA11010
  - Montreal, Quebec, Canada, H3T 1E2
    - Site CA11001
China
- - Beijing, China, 100036
    - Site CN86001
  - Beijing, China, 100050
    - Site CN86004
  - Beijing, China, 100191
    - Site CN86005
  - Beijing City, China, 100021
    - Site CN86009
  - Bengbu, China, 233000
    - Site CN86015
  - Changchun, China, 130021
    - Site CN86003
  - Changsha, China, 410013
    - Site CN86006
  - Changsha, China, 410013
    - Site CN86016
  - Chengdu, China, 610041
    - Site CN86010
  - Chongqing, China, 400030
    - Site CN86024
  - Chongqing, China, 400038
    - Site CN86007
  - Fuzhou, China, 350005
    - Site CN86028
  - Guangzhou, China, 510120
    - Site CN86002
  - Gunagzhou, China, 510280
    - Site CN86020
  - Hangzhou, China, 0571
    - Site CN86018
  - Hangzhou, China, 310014
    - Site CN86013
  - Hangzhou, China, 310016
    - Site CN86022
  - Hefei, China, 400030
    - Site CN86025
  - Jinan, China, 250021
    - Site CN86027
  - Nanjing, China, 210008
    - Site CN86017
  - Nanjing, China, 210029
    - Site CN86012
  - Ningbo, China, 315016
    - Site CN86021
  - Shanghai, China, 200040
    - Site CN86014
  - Shenyang City, China, 110022
    - Site CN86011
  - Tianjin, China, 300052
    - Site CN86023
  - Tianjin, China, 453000
    - Site CN86019
  - Wenzhou, China, 325000
    - Site CN86029
  - Wuhan City, China, 430030
    - Site CN86008
  - Xicheng District, China, 100034
    - Site CN86030
  - Xuzhou, China, 221009
    - Site CN86026
Czechia
- - Brno, Czechia, 656 91
    - Site CZ42006
  - Hradec Kralove, Czechia, 500 05
    - Site CZ42001
  - Olomouc, Czechia, 779 00
    - Site CZ42004
  - Praha 4-Krc, Czechia, 140 59
    - Site CZ42005
Denmark
- - Aalborg, Denmark, 9100
    - Site DK45001
  - Aarhus N, Denmark, 8200
    - Site DK45003
France
- - Bordeaux, France, 33000
    - Site FR33014
  - Lyon, France, 69373
    - Site FR33016
  - Nice Cedex 2, France, 06189
    - Site FR33003
  - Pierre-Bénite, France, 69495
    - Site FR33020
  - Strasbourg, France, 67200
    - Site FR33013
  - TOURS Cedex 09, France, 37044
    - Site FR33017
  - Villejuif-Cedex-France, France, 94805
    - Site FR33011
Germany
- - Berlin, Germany, 10117
    - Site DE49003
  - Bielefeld, Germany, 33611
    - Site DE49013
  - Düsseldorf, Germany, 40225
    - Site DE49016
  - Erlangen, Germany, 91054
    - Site DE49014
  - Essen, Germany, 45147
    - Site DE49011
  - Frankfurt am Main, Germany, 60488
    - Site DE49007
  - Gottingen, Germany, 37099
    - Site DE49015
  - Heidelberg, Germany, 69120
    - Site DE49005
  - Herne, Germany, 44649
    - Site DE49009
  - Jena, Germany, 07747
    - Site DE49006
  - Lubeck, Germany, 23538
    - Site DE49001
  - Magdeburg, Germany, 39120
    - Site DE49008
  - Mannheim, Germany, 68167
    - Site DE49012
  - Munchen, Germany, 81675
    - Site DE49002
  - Tübingen, Germany, 72076
    - Site DE49004
  - Ulm, Germany, 89081
    - Site DE49010
Hungary
- - Budapest, Hungary, 1083
    - Site HU36003
  - Budapest, Hungary, 1122
    - Site HU36002
  - Debrecen, Hungary, 4032
    - Site HU36006
  - Nyiregyhaza, Hungary, 4400
    - Site HU36001
  - Szolnok, Hungary, 5004
    - Site HU36005
Israel
- - Beer Sheva, Israel, 84101
    - Site IL97203
  - Haifa, Israel, 31096
    - Site IL97201
  - Holon, Israel, 58100
    - Site IL97209
  - Jerusalem, Israel, 91120
    - Site IL97206
  - Kfar Saba, Israel, 44281
    - Site IL97202
  - Petach Tikva, Israel, 49414
    - Site IL97208
  - Rehovot, Israel, 76100
    - Site IL97211
  - Tel Aviv, Israel, 64239
    - Site IL97210
  - Tel Hashomer, Israel, 52621
    - Site IL97204
  - Zerifin, Israel, 70300
    - Site IL97205
Italy
- - Areezo, Italy, 52100
    - Site IT39005
  - Candiolo, Italy, 10060
    - Site IT39008
  - Cremona, Italy, 26100
    - Site IT39009
  - Genova, Italy, 16132
    - Site IT39006
  - Meldola, Italy, 47014
    - Site IT39003
  - Milano, Italy, 20132
    - Site IT39014
  - Milano, Italy, 20141
    - Site IT39007
  - Pisa, Italy, 56126
    - Site IT39004
  - Terni, Italy, 05100
    - Site IT39002
  - Torrette, Italy, 60126
    - Site IT39011
  - Verona, Italy, 37134
    - Site IT39001
Japan
- - Bunkyo City, Japan
    - Site JP81002
  - Chiba, Japan
    - Site JP81009
  - Chiba, Japan
    - Site JP81018
  - Fukuoka, Japan
    - Site JP81013
  - Fukuoka, Japan
    - Site JP81020
  - Hirosaki, Japan
    - Site JP81011
  - Kawasaki-shi, Japan
    - Site JP81006
  - Koto-ku, Japan
    - Site JP81001
  - Kyoto, Japan
    - Site JP81017
  - Niigata, Japan
    - Site JP81015
  - Okayama, Japan
    - Site JP81005
  - Osaka, Japan
    - Site JP81008
  - Osakasayama-Shi, Japan
    - Site JP81016
  - Sapporo, Japan
    - Site JP81007
  - Sendai-city, Japan
    - Site JP81012
  - Tokushima, Japan
    - Site JP81014
  - Tokyo, Japan
    - Site JP81019
  - Toyama, Japan
    - Site JP81003
  - Tsukuba, Japan
    - Site JP81004
  - Ube, Japan
    - Site JP81010
Korea, Republic of
- - Daejeon, Korea, Republic of, 301-721
    - Site KR82001
  - Goyang-si, Korea, Republic of, 10408
    - Site KR82002
  - Hwasun, Korea, Republic of, 519-763
    - Site KR82008
  - Seongnam-si, Korea, Republic of, 13605
    - Site KR82004
  - Seoul, Korea, Republic of, 05505
    - Site KR82005
  - Seoul, Korea, Republic of, 03722
    - Site KR82003
  - Seoul, Korea, Republic of, 135-710
    - Site KR82007
  - Seoul, Korea, Republic of, 137-701
    - Site KR82006
Netherlands
- - Amsterdam, Netherlands, 1066 CX
    - Site NL31002
  - Amsterdam, Netherlands, 1081 HV
    - Site NL31001
  - Amsterdam, Noord-Holland, Netherlands, 1066 CX
    - Site NL31005
  - Leeuwarden, Netherlands, 8934 AD
    - Site NL31007
  - Nieuwegein, Netherlands, 3435 CM
    - Site NL31004
  - Rotterdam, Netherlands, 3075 EA
    - Site NL31003
  - Utrecht, Netherlands, 3584 CX
    - Site NL31006
Poland
- - Warszawa, Poland, 01-748
    - Site PL48002
Russian Federation
- - Arkhangelsk, Russian Federation, 163045
    - Site RU70016
  - Barnaul, Russian Federation, 656049
    - Site RU70013
  - Ivanovo, Russian Federation, 153040
    - Site RU70020
  - Krasnoyarsk, Russian Federation, 660133
    - Site RU70014
  - Leningradskaya Oblast', Russian Federation, 188663
    - Site RU70006
  - Moscow, Russian Federation, 125284
    - Site RU70003
  - Moscow, Russian Federation, 105077
    - Site RU70004
  - Moscow, Russian Federation, 123056
    - Site RU70011
  - Nizhniy Novgorod, Russian Federation, 603074
    - Site RU70017
  - Omsk, Russian Federation, 644013
    - Site RU70002
  - Pyatigorsk, Russian Federation, 357502
    - Site RU70019
  - Saint Petersburg, Russian Federation, 195271
    - Site RU70010
  - Saint Petersburg, Russian Federation, 197082
    - Site RU70007
  - Saint-Petersburg, Russian Federation, 197758
    - Site RU70012
  - Saransk, Russian Federation, 430032
    - Site RU70009
  - St. Petersburg, Russian Federation, 197758
    - Site RU70008
  - Tyumen, Russian Federation, 625041
    - Site RU70015
  - Ufa, Russian Federation, 450000
    - Site RU70005
Singapore
- - Singapore, Singapore, 119074
    - Site SG65001
  - Singapore, Singapore, 169610
    - Site SG65002
  - Singapore, Singapore, 308433
    - Site SG65003
Spain
- - Barcelona, Spain, 08035
    - Site ES34010
  - Barcelona, Spain, 08003
    - Site ES34017
  - Barcelona, Spain, 08036
    - Site ES34006
  - Barcelona, Spain, 08041
    - Site ES34001
  - Barcelona, Spain, 08907
    - Site ES34008
  - Cordoba, Spain, 14004
    - Site ES34013
  - Lugo, Spain, 27003
    - Site ES34021
  - Madrid, Spain, 28041
    - Site ES34015
  - Madrid, Spain, 28007
    - Site ES34018
  - Madrid, Spain, 28034
    - Site ES34002
  - Madrid, Spain, 28040
    - Site ES34003
  - Manresa, Spain, 08243
    - Site ES34004
  - Pamplona, Spain, 31008
    - Site ES34020
  - Sabadell, Spain, 08208
    - Site ES34016
  - Santander, Spain, 39008
    - Site ES34012
  - Sevilla, Spain, 41013
    - Site ES34007
  - Valencia, Spain, 46009
    - Site ES34019
  - Valencia, Spain, 46014
    - Site ES34009
Switzerland
- - Basel, Switzerland, 4031
    - Site CH41004
  - Bern, Switzerland, 3010
    - Site CH41002
  - Chur, Switzerland, 7000
    - Site CH41001
  - Winterthur, Switzerland, 8401
    - Site CH41003
Taiwan
- - Kaohsiung, Taiwan, 83301
    - Site TW88603
  - Kweishan, Taiwan, 333
    - Site TW88602
  - Taichung, Taiwan, 40705
    - Site TW88606
  - Taichung, Taiwan, 40447
    - Site TW88607
  - Tainan, Taiwan, 70403
    - Site TW88604
  - Taipei, Taiwan, 10002
    - Site TW88605
  - Taipei, Taiwan, 11217
    - Site TW88601
Thailand
- - Bangkok, Thailand, 10330
    - Site TH66004
  - Bangkok, Thailand, 10400
    - Site TH66003
  - Chiang Mai, Thailand, 50200
    - Site TH66005
  - HatYai, Thailand, 90110
    - Site TH66002
  - Krung Thep Maha Nakhon, Thailand, 10700
    - Site TH66006
  - Muang, Thailand, 40002
    - Site TH66007
  - Ratchathewi, Thailand, 10400
    - Site TH66001
Turkey
- - Ankara, Turkey, 6100
    - Site TR90007
  - Ankara, Turkey, 6230
    - Site TR90009
  - Antalya, Turkey, 07059
    - Site TR90005
  - Edirne, Turkey, 22030
    - Site TR90004
  - Istanbul, Turkey, 34093
    - Site TR90008
  - Istanbul, Turkey, 34214
    - Site TR90003
  - Istanbul, Turkey, 81450
    - Site TR90002
  - Konya, Turkey, 42080
    - Site TR90001
  - Malatya, Turkey, 44280
    - Site TR90006
United Kingdom
- - Glasgow, United Kingdom, G12 0YN
    - Site UK44005
  - London, United Kingdom, EC1M 6BQ
    - Site UK44001
  - London, United Kingdom, W6 8RF
    - Site UK44009
  - Oxford, United Kingdom, OX3 7LE
    - Site UK44006
  - Plymouth, United Kingdom, PL6 8DH
    - Site UK44010
  - Preston, United Kingdom, PR2 9HT
    - Site UK44002
  - Sheffield, United Kingdom, S10 2RX
    - Site UK44003
  - Southampton, United Kingdom, SO16 6YD
    - Site UK44008
United States
- Arizona
  - Chandler, Arizona, United States, 85224
    - Ironwood Cancer & Research Centers - Chandler
  - Tucson, Arizona, United States, 85710
    - Arizona Oncology Associates PD - HOPE
- California
  - Burbank, California, United States, 91505
    - Providence St Joseph Medical Center
  - Duarte, California, United States, 91010
    - City of Hope National Medical Center
  - Los Angeles, California, United States, 90095
    - University of California Los Angeles Medical Center
  - Orange, California, United States, 92868
    - University of California Irvine - Newport
- Colorado
  - Aurora, Colorado, United States, 80012
    - Rocky Mountain Cancer Centers - Aurora
  - Aurora, Colorado, United States, 80045
    - University of Colorado Hospital / University of Colorado
  - Denver, Colorado, United States, 80218
    - Cancer Centers of Colorado - Denver
- Connecticut
  - New Haven, Connecticut, United States, 06520
    - Yale Cancer Center
  - Norwich, Connecticut, United States, 06360
    - Eastern CT Hematology and Oncology Associates
- District of Columbia
  - Washington, District of Columbia, United States, 20007
    - Lombardi Cancer Center / Georgetown University Medical Center
- Florida
  - Tampa, Florida, United States, 33612
    - H. Lee Moffitt Cancer Center and Research Institute
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Winship Cancer Institute / Emory University School of Medicine
  - Marietta, Georgia, United States, 30060
    - Georgia Cancer Specialists / Northside Hospital Cancer Institute
- Louisiana
  - Metairie, Louisiana, United States, 70006
    - Louisiana State University/ East Jefferson General Hospital
- Maine
  - Biddeford, Maine, United States, 04046
    - Maine Health Cancer Care
- Maryland
  - Baltimore, Maryland, United States, 21231
    - Johns Hopkins Medical Center
- Nevada
  - Las Vegas, Nevada, United States, 89169
    - Comprehensive Cancer Centers of Nevada
- New Mexico
  - Albuquerque, New Mexico, United States, 87109
    - New Mexico Cancer Center
- New York
  - New York, New York, United States, 10065
    - Memorial Sloan Kettering Cancer Center
  - New York, New York, United States, 10029
    - Mount Sinai Medical Center
  - New York, New York, United States, 10016
    - New York University (NYU) Cancer Institute
- North Carolina
  - Greenville, North Carolina, United States, 27834
    - Vidant Medical Center
- Ohio
  - Cleveland, Ohio, United States, 44195
    - The Cleveland Clinic
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic Cancer Center
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15232
    - Hillman Cancer Center / University of Pittsburgh Medical Center
- South Carolina
  - Greenville, South Carolina, United States, 29607
    - Saint Francis Hospital / Bon Secours - South Carolina
- Tennessee
  - Germantown, Tennessee, United States, 38138
    - West Cancer Center & Research Institute
- Texas
  - Dallas, Texas, United States, 75390
    - University of Texas Southwestern Medical Center
  - Tyler, Texas, United States, 75701
    - UT health east Texas HOPE Cancer Center
- Utah
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Institute
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia
- Washington
  - Seattle, Washington, United States, 98109
    - Seattle Cancer Care Alliance / University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Histologically documented, unresectable locally advanced or metastatic urothelial carcinoma
Measurable disease by investigator assessment according to RECIST v1.1
- Participants with prior definitive radiation therapy must have measurable disease per RECIST v1.1 that is outside the radiation field or has demonstrated unequivocal progression since completion of radiation therapy
Participants must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions:
- Participants that received neoadjuvant chemotherapy with recurrence >12 months from completion of therapy are permitted
- Participants that received adjuvant chemotherapy following cystectomy with recurrence >12 months from completion of therapy are permitted
Must be considered eligible to receive cisplatin- or carboplatin-containing chemotherapy, in the investigator's judgment
Archival tumor tissue comprising muscle-invasive urothelial carcinoma or a biopsy of metastatic urothelial carcinoma must be provided for PD-L1 testing prior to randomization
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
Adequate hematologic and organ function

Exclusion Criteria:

Previously received enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody-drug conjugate (ADCs)
Received prior treatment with a programmed cell death ligand-1 (PD-(L)-1) inhibitor for any malignancy, including earlier stage urothelial cancer (UC), defined as a PD-1 inhibitor or PD-L1 inhibitor
Received prior treatment with an agent directed to another stimulatory or co inhibitory T-cell receptor
Received anti-cancer treatment with chemotherapy, biologics, or investigational agents not otherwise prohibited by exclusion criterion 1-3 that is not completed 4 weeks prior to first dose of study treatment
Uncontrolled diabetes
Estimated life expectancy of less than 12 weeks
Active central nervous system (CNS) metastases
Ongoing clinically significant toxicity associated with prior treatment that has not resolved to ≤ Grade 1 or returned to baseline
Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of randomization. Routine antimicrobial prophylaxis is permitted.
Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
History of another invasive malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy
Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class IV within 6 months prior to randomization
Receipt of radiotherapy within 2 weeks prior to randomization
Received major surgery (defined as requiring general anesthesia and >24 hour inpatient hospitalization) within 4 weeks prior to randomization
Known severe (≥ Grade 3) hypersensitivity to any enfortumab vedotin excipient contained in the drug formulation of enfortumab vedotin
Active keratitis or corneal ulcerations
History of autoimmune disease that has required systemic treatment in the past 2 years
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Prior allogeneic stem cell or solid organ transplant
Received a live attenuated vaccine within 30 days prior to randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A Enfortumab vedotin + pembrolizumab	Drug: Enfortumab vedotin Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle Other Names: ASG-22CE PADCEV ASG-22ME Drug: Pembrolizumab IV infusion on Day 1 of every 3-week cycle Other Names: Keytruda
Active Comparator: Arm B Gemcitabine + cisplatin or carboplatin	Drug: Cisplatin administered as IV infusion on Day 1 of each 3-week cycle Drug: Carboplatin Dosed according to local guidelines and will be administered as IV infusion on Day 1 of each 3-week cycle Drug: Gemcitabine IV infusion on Days 1 and 8 of every 3 week cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Blinded Independent Central Review (BICR) Time Frame: From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum exposure to treatment was up to 39.2 months)	PFS was defined as the time from date of randomization to first documentation of disease progression (PD), or to death due to any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). PD could also be unequivocal progression of non-target lesions or the presence of unequivocal new lesions. Kaplan-Meier method was used for analysis.	From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum exposure to treatment was up to 39.2 months)
Overall Survival (OS) Time Frame: From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum exposure to treatment was up to 39.2 months)	OS was defined as the time from the date of randomization to the date of death from any cause. In the absence of death, OS was censored at the date the participant was last known to be alive. Kaplan-Meier method was used for analysis.	From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum exposure to treatment was up to 39.2 months)

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Global Development, Inc.

Collaborators

Merck Sharp & Dohme LLC

Seagen Inc.

Investigators

Study Director: Zejing Wang, MD, PhD, Seagen Inc.
Study Director: John Lu, MD, Seagen Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Hoimes CJ, Flaig TW, Milowsky MI, Friedlander TW, Bilen MA, Gupta S, Srinivas S, Merchan JR, McKay RR, Petrylak DP, Sasse C, Moreno BH, Yu Y, Carret AS, Rosenberg JE. Enfortumab Vedotin Plus Pembrolizumab in Previously Untreated Advanced Urothelial Cancer. J Clin Oncol. 2023 Jan 1;41(1):22-31. doi: 10.1200/JCO.22.01643. Epub 2022 Aug 30.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2020

Primary Completion (Actual)

August 8, 2023

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 8, 2020

First Posted (Actual)

January 10, 2020

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

SGN22E-003
2019-004542-15 (EudraCT Number)
MK-3475-A39 (Other Identifier: Merck)
KEYNOTE KN-A39 (Other Identifier: Merck)
jRCT2031200284 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))
CTR20220974 (Other Identifier: ChinaDrugTrials.org.cn)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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Clinical Trials on Urothelial Cancer

Aron Research Foundation Ets

Not yet recruiting

International Multicentric Retrospective Study on the Use of EV+P as First-line Therapy in Patients With la/mUC (ARON-2PLUS)

Urothelial Cancer | Locally Advanced or Metastatic Urothelial Cancer

Italy
Fondazione Policlinico Universitario Agostino Gemelli...

Recruiting

DDR Genes Alteration and Response to Platinum-based Chemotherapy in Advanced Urothelial Cancer. (SELECTIO-UC)

Upper Tract Urothelial Cancer | Bladder (Urothelial, Transitional Cell) Cancer Metastatic or Unresectable

Italy
Janssen Research & Development, LLC

Active, not recruiting

A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations (THOR)

Urothelial Cancer

United States, Spain, Japan, United Kingdom, Belgium, Israel, Italy, France, China, Austria, Taiwan, Canada, Argentina, Bulgaria, Netherlands, Germany, Greece, Brazil, Australia, Mexico, Ukraine, Hungary, Portugal, Poland, South Korea, Turkey... and more
Janssen Research & Development, LLC

Active, not recruiting

An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer

Urothelial Cancer

United States, France, United Kingdom, Belgium, Germany, Taiwan, Spain, Israel, India, Romania, Austria, Moldova, Russia, South Korea, Turkey (Türkiye)
Hoffmann-La Roche

Active, not recruiting

A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer

Urothelial Cancer

United States, France, Spain, Denmark, China, Poland, Germany, United Kingdom, Italy, Greece, Australia, Brazil, South Korea, Turkey (Türkiye), Mexico
Monika Joshi, MD
AstraZeneca

Terminated

Durvalumab And Radiation Therapy Followed by Adjuvant Durvalumab in Patients With Urothelial Cancer (T2-4 N0-2 M0) of the Bladder (DUART)

Urothelial Cancer

United States
Abramson Cancer Center of the University of Pennsylvania

Withdrawn

RADVAX™: A Trial of Combined Pembrolizumab and Hypofractionated Radiation in Patients With Advanced Urothelial Cancer Who Have Progressed on Anti-PD-1/PD-L1 Monotherapy

Urothelial Cancer

United States
AstraZeneca

Active, not recruiting

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer

Urothelial Cancer

United States, Belgium, Denmark, Germany, Italy, Spain, Canada, France, Netherlands, United Kingdom, Brazil, Japan, Mexico, Poland, China, Taiwan, Austria, Australia, Israel, Portugal, Greece, South Korea, Russia, Turkey (Türkiye)
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

Active, not recruiting

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer (CheckMate901)

Urothelial Cancer

United States, Spain, Germany, Argentina, Australia, Canada, Chile, China, Czechia, Denmark, Finland, France, Israel, Italy, Japan, Netherlands, Norway, Peru, Poland, Romania, Sweden, Switzerland, Taiwan, Greece, Singapore, Brazil, Mexico, Ru... and more
Azienda Ospedaliera Universitaria Integrata Verona
Casa di Cura Dott. Pederzoli; Ospedale Mater Salutis-Legnago(Verona), Italy

Completed

Evaluation of Clinical Outcomes, Tolerability, and Costs of Avelumab Maintenance and Pembrolizumab Second-Line Therapy in Advanced Urothelial Cancer. (AvePem)

Urothelial Cancer

Italy

Clinical Trials on Enfortumab vedotin

National Cancer Center, Japan
Astellas Pharma Inc

Recruiting

Enfortumab Vedotin in Patients With Advanced Small Bowel Adenocarcinoma Refractory or Intolerant to Platinum-based Combination Therapy (ENVELOPE)

Advanced Small Bowel Adenocarcinoma

Japan
Memorial Sloan Kettering Cancer Center
Astellas Pharma US, Inc.

Recruiting

A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma

Adenoid Cystic Carcinoma

United States
University of Utah
Astellas Pharma Inc

Active, not recruiting

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

Metastatic Castration-resistant Prostate Cancer

United States
Memorial Sloan Kettering Cancer Center
Astellas Pharma US, Inc.

Recruiting

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

Urothelial Carcinoma

United States
Fox Chase Cancer Center
United States Department of Defense

Recruiting

Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma (IMPROEV)

Metastatic Urothelial Carcinoma | Unresectable Urothelial Carcinoma | Advanced Urothelial Carcinoma

United States
Astellas Pharma Global Development, Inc.
Pfizer

Recruiting

A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer

Metastatic Urothelial Carcinoma

India
Astellas Pharma Korea, Inc.
Seagen Inc.

Recruiting

A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection

Urothelial Cancer

South Korea
Astellas Pharma China, Inc.
Seagen Inc.

Completed

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

Metastatic Urothelial Cancer

China
Astellas Pharma Global Development, Inc.
Seagen Inc.

Approved for marketing

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

Locally Advanced or Metastatic Urothelial Carcinoma (UC)

United States
William Bradley
Astellas Pharma Inc

Not yet recruiting

Study of EV for Recurrent Endometrial Carcinoma (EV-4-EC)

Endometrial Cancer

United States

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Objective Response Rate (ORR) Per RECIST v1.1 by BICR Time Frame: From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years)	ORR as per RECIST v1.1 by BICR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) CR was defined as disappearance of all lesions including non-target lesions (not just target lesions). Any pathological lymph nodes must have reduction in short axis to<10 mm. PR was defined as at least 30 percent [%] decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response.	From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years)
Time to Pain Progression (TTPP) Time Frame: From the date of randomization to date of pain progression (maximum up to approximately 7.4 years)	TTPP was defined as the time from the date of randomization to date of pain progression. Pain progression was defined as a participant reporting either of the following, whichever came first: 1) Increase of 2 or more points from baseline on Brief Pain Inventory - Short Form (BPI-SF) Question 3 (i.e., pain at its worst in the last 24 hours, score range 0 to 10 with higher scores associated with higher pain levels) maintained for at least two consecutive assessments. 2) Initiation of new opioid medication from baseline for pain with usage maintained for at least two consecutive assessments as recorded in BPI-SF Question 7 (i.e., What medications received for pain).	From the date of randomization to date of pain progression (maximum up to approximately 7.4 years)
Change From Baseline in Worst Pain Using BPI-SF at Week 26 Time Frame: Baseline, Week 26	Brief Pain Inventory (BPI-SF) was defined as summary of the worst, least, and average pain experienced in the last 24 hours as well as pain right now and number of pain locations were provided for each treatment arm. BPI-sf worst pain measured the severity of pain based on the pain at its worst in the last 24 hours, score range 0 to 10 with higher scores associated with higher pain levels.	Baseline, Week 26
PFS Per RECIST v1.1 by Investigator Assessment Time Frame: From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 7.4 years)	PFS as per RECIST v1.1 by investigator was defined as the time from date of randomization to first documentation of PD, or to death due to any cause, whichever comes first. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PD could also be unequivocal progression of non-target lesions or the presence of unequivocal new lesions.	From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 7.4 years)
ORR Per RECIST v1.1 by Investigator Assessment Time Frame: From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years)	ORR as per RECIST v1.1 by investigator was defined as the percentage of participants with confirmed CR or PR. CR was defined as disappearance of all lesions including non-target lesions (not just target lesions). Any pathological lymph nodes must have reduction in short axis to<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response.	From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years)
Duration of Response (DOR) Per RECIST v1.1 by BICR Time Frame: From the date of first documented response of CR or PR to the first documented disease progression or to death from any cause, whichever occurred first (maximum up to approximately 7.4 years)	DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to the first documented PD per RECIST v1.1 per BICR or death from any cause, whichever occurs first. DOR will only include subjects with a confirmed response (CR or PR per RECIST v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.	From the date of first documented response of CR or PR to the first documented disease progression or to death from any cause, whichever occurred first (maximum up to approximately 7.4 years)
DOR Per RECIST v1.1 by Investigator Assessment Time Frame: From the date of first documented response of CR or PR to the first documented disease progression or to death from any cause, whichever occurred first (maximum up to approximately 7.4 years)	DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to the first documented PD per RECIST v1.1 per investigator or death from any cause, whichever occurs first. DOR will only include subjects with a confirmed response (CR or PR per RECIST v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response.	From the date of first documented response of CR or PR to the first documented disease progression or to death from any cause, whichever occurred first (maximum up to approximately 7.4 years)
Disease Control Rate (DCR) Per RECIST v1.1 by BICR Time Frame: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to approximately 7.4 years)	DCR by BICR was defined as the percentage of participants with confirmed response (CR or PR), or SD (or non-CR/non-PD), per RECIST v1.1. Subjects who have no post-baseline response assessments will be considered as non-responders for calculating the DCR. Only response assessments before the first documented PD or subsequent anticancer therapies were considered. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. SD was defined as a change in tumor size that is neither radiological response (>30% shrinkage) nor progression (>20% growth).	From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to approximately 7.4 years)
DCR Per RECIST v1.1 by Investigator Assessment Time Frame: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to approximately 7.4 years)	DCR by BICR was defined as the percentage of participants with confirmed response (CR or PR), or SD (or non-CR/non-PD), per RECIST v1.1. Subjects who have no post-baseline response assessments will be considered as non-responders for calculating the DCR. Only response assessments before the first documented PD or subsequent anticancer therapies were considered. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. SD was defined as a change in tumor size that is neither radiological response (>30% shrinkage) nor progression (>20% growth).	From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to approximately 7.4 years)
Mean Scores in Patient Reported Outcome (PRO) Assessment Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Time Frame: End of study (approximately up to 7.4 years)	The EQ-5D-5L is a 5-item self-reported measure of functioning and well-being, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (EQ-5D-5L User Guide, 2019). Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems).	End of study (approximately up to 7.4 years)
Change From Baseline in PRO Assessment Measured by the EQ-5D-5L Time Frame: Baseline, End of study (approximately up to 7.4 years)	The EQ-5D-5L is a 5-item self-reported measure of functioning and well-being, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (EQ-5D-5L User Guide, 2019). Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems).	Baseline, End of study (approximately up to 7.4 years)
Mean Scores in PRO Assessment Measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Time Frame: End of study (approximately up to 7.4 years)	EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms.	End of study (approximately up to 7.4 years)
Change From Baseline in PRO Assessment Measured by EORTC QLQ-C30 Time Frame: Baseline, End of study (approximately up to 7.4 years)	EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.	Baseline, End of study (approximately up to 7.4 years)
Number of Participants With Treatment Emergent Adverse Events Adverse Events (AEs) Time Frame: From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state.	From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)
Number of Participants With Serious TEAE Time Frame: From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)	SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state.	From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)
Number of Participants With Grade 3-5 TEAE Time Frame: From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)	AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per common terminology criteria for adverse events (CTCAE) version 4, Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE.	From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)
Number of Participants Related to Treatment AEs Time Frame: From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment relatedness was assessed by the investigator.	From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)
Number of Participants With Laboratory Abnormalities Time Frame: From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)	Laboratory abnormalities included Hematology and Serum Chemistry. In Hematology (increased : hemoglobin, lymphocytes, leukocytes, and decreased : hemoglobin, lymphocytes, neutrophils, platelets and leukocytes) and In serum chemistry (increased in : alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium corrected for albumin, creatinine, glucose (non-fasting), potassium, sodium, and decreased in albumin, calcium corrected for albumin, glucose (non-fasting), potassium, phosphate and sodium).	From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)
Number of Participants With Treatment Discontinuation Rate Due to AEs Time Frame: During study (approximately up to 7.4 years)		During study (approximately up to 7.4 years)

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer (EV-302)

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

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Studies a U.S. FDA-regulated drug product

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Clinical Trials on Urothelial Cancer

Clinical Trials on Enfortumab vedotin

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