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

December 5, 2023 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

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 (Estimated)

990

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 Contact

Name: Seagen Inc. Trial Information Support
Phone Number: 866-333-7436
Email: clinicaltrials@seagen.com

Study Locations

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR) (Arms A and B only, global population) Time Frame: Up to approximately 5 years	Defined as the time from randomization to first documentation of disease progression per RECIST v1.1 by BICR, or to death due to any cause, whichever comes first.	Up to approximately 5 years
Duration of Overall survival (OS) (Arms A and B only, global population) Time Frame: Up to approximately 5 years	OS is defined as the time from date of randomization to date of death due to any cause.	Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of PFS per RECIST v1.1 by investigator assessment (Arms A and B only) Time Frame: Up to approximately 5 years	Defined as the time from randomization to first documentation of disease progression per RECIST v1.1, or to death due to any cause, whichever comes first	Up to approximately 5 years
Objective response rate (ORR) per RECIST v1.1 by BICR (Arms A and B only) Time Frame: Up to approximately 5 years	Defined as the proportion of subjects with confirmed CR or PR according to RECIST v1.1	Up to approximately 5 years
ORR per RECIST v1.1 by investigator assessment (Arms A and B only) Time Frame: Up to approximately 5 years	Defined as the proportion of subjects with confirmed CR or PR according to RECIST v1.1	Up to approximately 5 years
Duration of response (DOR) per RECIST v1.1 by BICR (Arms A and B only) Time Frame: Up to approximately 5 years	Defined as the time from first documented response of CR or PR (that is subsequently confirmed) to the first documented disease progression per RECIST v1.1, or to death due to any cause, whichever comes first	Up to approximately 5 years
DOR per RECIST v1.1 by investigator assessment (Arms A and B only) Time Frame: Up to approximately 5 years	Defined as the time from first documented response of CR or PR (that is subsequently confirmed) to the first documented disease progression per RECIST v1.1, or to death due to any cause, whichever comes first	Up to approximately 5 years
Disease control rate (DCR) per RECIST v1.1 by BICR (Arms A and B only) Time Frame: Up to approximately 5 years	Defined as the proportion of subjects with confirmed CR, PR, or SD according to RECIST v1.1	Up to approximately 5 years
DCR per RECIST v1.1 by investigator assessment (Arms A and B only) Time Frame: Up to approximately 5 years	Defined as the proportion of subjects with confirmed CR, PR, or SD according to RECIST v1.1	Up to approximately 5 years
Change from baseline in patient reported outcome assessment measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Time Frame: Up to approximately 5 years	The EQ-5D-5L is a standardized instrument developed by the EuroQol Group for use as a generic, preference-based measure of health outcomes. The EQ-5D-5L is a 5-item self-reported measure of functioning and wellbeing, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). A unique EQ-5D-5L health state is defined by combining 1 level from each of the 5 dimensions. This questionnaire also records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale.	Up to approximately 5 years
Change from baseline in patient reported outcome assessment measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Time Frame: Up to approximately 5 years	EORTC-QLQ-C30 is a cancer-specific 30-item questionnaire. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.	Up to approximately 5 years
Incidence of adverse events (AEs) Time Frame: Up to approximately 5 years	Descriptive statistics will be used to summarize results	Up to approximately 5 years
Incidence of laboratory abnormalities Time Frame: Up to approximately 5 years	Descriptive statistics will be used to summarize results	Up to approximately 5 years
Treatment discontinuation rate due to AEs Time Frame: Up to approximately 5 years	Descriptive statistics will be used to summarize results	Up to approximately 5 years
Time to pain progression (TTPP) (Arms A and B only) Time Frame: Up to approximately 5 years	Defined as the time from randomization to the first date a subject experiences a pain progression. Pain progression is defined as either an increase of 2 or more points from baseline on question 3 of the Brief Pain Inventory - Short Form (BPI-SF) or initiation of new opioid pain medication.	Up to approximately 5 years
Mean scores in patient reported outcome assessment measured by the EQ-5D-5L Time Frame: Up to approximately 5 years	The EQ-5D-5L is a standardized instrument developed by the EuroQol Group for use as a generic, preference-based measure of health outcomes. The EQ-5D-5L is a 5-item self-reported measure of functioning and wellbeing, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). A unique EQ-5D-5L health state is defined by combining 1 level from each of the 5 dimensions. This questionnaire also records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale.	Up to approximately 5 years
Mean scores in patient reported outcome assessment measured by EORTC QLQ-C30 Time Frame: Up to approximately 5 years	EORTC-QLQ-C30 is a cancer-specific 30-item questionnaire. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.	Up to approximately 5 years
Mean change from baseline in worst pain at Week 26 (Arms A and B only) Time Frame: Up to approximately 6 months	Using the BPI-SF question 3, mean change from baseline in worst pain will be calculated for each postbaseline assessment timepoint for Arm A and Arm B.	Up to approximately 6 months

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)

September 30, 2027

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 (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Expanded Access

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Studies a U.S. FDA-regulated device product

Clinical Trials on Urothelial Cancer

Clinical Trials on Enfortumab vedotin

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