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

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

NCT ID: NCT04223856

Condition: Urothelial Cancer

Conditions: Official terms:
Carboplatin
Gemcitabine
Pembrolizumab

Conditions: Keywords:
Urothelial Cancer
Enfortumab vedotin
metastatic urothelial cancer
pembrolizumab
locally advanced urothelial cancer

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Enfortumab vedotin
Description: Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle
Arm group label: Arm A

Other name: ASG-22CE

Other name: ASG-22ME

Other name: PADCEV

Intervention type: Drug
Intervention name: Pembrolizumab
Description: IV infusion on Day 1 of every 3-week cycle
Arm group label: Arm A

Other name: Keytruda

Intervention type: Drug
Intervention name: Cisplatin
Description: administered as IV infusion on Day 1 of each 3-week cycle
Arm group label: Arm B

Intervention type: Drug
Intervention name: Carboplatin
Description: Dosed according to local guidelines and will be administered as IV infusion on Day 1 of each 3-week cycle
Arm group label: Arm B

Intervention type: Drug
Intervention name: Gemcitabine
Description: IV infusion on Days 1 and 8 of every 3 week cycle
Arm group label: Arm B

Summary: 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.

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Ironwood Cancer & Research Centers - Chandler

Address:
City: Chandler
Zip: 85224
Country: United States

Facility:
Name: Arizona Oncology Associates PD - HOPE

Address:
City: Tucson
Zip: 85710
Country: United States

Facility:
Name: Providence St Joseph Medical Center

Address:
City: Burbank
Zip: 91505
Country: United States

Facility:
Name: City of Hope National Medical Center

Address:
City: Duarte
Zip: 91010
Country: United States

Facility:
Name: University of California Los Angeles Medical Center

Address:
City: Los Angeles
Zip: 90095
Country: United States

Facility:
Name: University of California Irvine - Newport

Address:
City: Orange
Zip: 92868
Country: United States

Facility:
Name: Rocky Mountain Cancer Centers - Aurora

Address:
City: Aurora
Zip: 80012
Country: United States

Facility:
Name: University of Colorado Hospital / University of Colorado

Address:
City: Aurora
Zip: 80045
Country: United States

Facility:
Name: Cancer Centers of Colorado - Denver

Address:
City: Denver
Zip: 80218
Country: United States

Facility:
Name: Yale Cancer Center

Address:
City: New Haven
Zip: 06520
Country: United States

Facility:
Name: Eastern CT Hematology and Oncology Associates

Address:
City: Norwich
Zip: 06360
Country: United States

Facility:
Name: Lombardi Cancer Center / Georgetown University Medical Center

Address:
City: Washington
Zip: 20007
Country: United States

Facility:
Name: H. Lee Moffitt Cancer Center and Research Institute

Address:
City: Tampa
Zip: 33612
Country: United States

Facility:
Name: Winship Cancer Institute / Emory University School of Medicine

Address:
City: Atlanta
Zip: 30322
Country: United States

Facility:
Name: Georgia Cancer Specialists / Northside Hospital Cancer Institute

Address:
City: Marietta
Zip: 30060
Country: United States

Facility:
Name: Louisiana State University/ East Jefferson General Hospital

Address:
City: Metairie
Zip: 70006
Country: United States

Facility:
Name: Maine Health Cancer Care

Address:
City: Biddeford
Zip: 04046
Country: United States

Facility:
Name: Johns Hopkins Medical Center

Address:
City: Baltimore
Zip: 21231
Country: United States

Facility:
Name: Comprehensive Cancer Centers of Nevada

Address:
City: Las Vegas
Zip: 89169
Country: United States

Facility:
Name: New Mexico Cancer Center

Address:
City: Albuquerque
Zip: 87109
Country: United States

Facility:
Name: New York University (NYU) Cancer Institute

Address:
City: New York
Zip: 10016
Country: United States

Facility:
Name: Mount Sinai Medical Center

Address:
City: New York
Zip: 10029
Country: United States

Facility:
Name: Memorial Sloan Kettering Cancer Center

Address:
City: New York
Zip: 10065
Country: United States

Facility:
Name: Vidant Medical Center

Address:
City: Greenville
Zip: 27834
Country: United States

Facility:
Name: The Cleveland Clinic

Address:
City: Cleveland
Zip: 44195
Country: United States

Facility:
Name: Toledo Clinic Cancer Center

Address:
City: Toledo
Zip: 43623
Country: United States

Facility:
Name: Hillman Cancer Center / University of Pittsburgh Medical Center

Address:
City: Pittsburgh
Zip: 15232
Country: United States

Facility:
Name: Saint Francis Hospital / Bon Secours - South Carolina

Address:
City: Greenville
Zip: 29607
Country: United States

Facility:
Name: West Cancer Center & Research Institute

Address:
City: Germantown
Zip: 38138
Country: United States

Facility:
Name: University of Texas Southwestern Medical Center

Address:
City: Dallas
Zip: 75390
Country: United States

Facility:
Name: UT Health East Texas Hope Cancer Center

Address:
City: Tyler
Zip: 75701
Country: United States

Facility:
Name: Huntsman Cancer Institute

Address:
City: Salt Lake City
Zip: 84112
Country: United States

Facility:
Name: University of Virginia

Address:
City: Charlottesville
Zip: 22908
Country: United States

Facility:
Name: Seattle Cancer Care Alliance / University of Washington

Address:
City: Seattle
Zip: 98109
Country: United States

Facility:
Name: Site AR54008

Address:
City: Buenos Aire
Zip: C1019ABS
Country: Argentina

Facility:
Name: Site AR54011

Address:
City: Caba
Zip: C1426ANZ
Country: Argentina

Facility:
Name: Site AR54005

Address:
City: Cordoba
Zip: X5004FHP
Country: Argentina

Facility:
Name: Site AR54006

Address:
City: La Rioja
Zip: 5300
Country: Argentina

Facility:
Name: Site AR54004

Address:
City: Mendoza
Zip: M5500AYB
Country: Argentina

Facility:
Name: Site AR54001

Address:
City: Rosario
Zip: 2000
Country: Argentina

Facility:
Name: Site AR54002

Address:
City: San Miguel
Zip: T400GTB
Country: Argentina

Facility:
Name: Site AR54012

Address:
City: Tucuman
Zip: T4000IAK
Country: Argentina

Facility:
Name: Site AR54003

Address:
City: Viedma
Zip: 8500
Country: Argentina

Facility:
Name: Site AU61003

Address:
City: Box Hill
Zip: 3128
Country: Australia

Facility:
Name: Site AUS61001

Address:
City: Douglas
Zip: 4814
Country: Australia

Facility:
Name: Site AUS61004

Address:
City: Heidelberg
Zip: 3084
Country: Australia

Facility:
Name: Site AUS61002

Address:
City: Macquarie Park
Zip: 2109
Country: Australia

Facility:
Name: Site AUS61006

Address:
City: South Australia
Zip: 5112
Country: Australia

Facility:
Name: Site AU61005

Address:
City: South Brisbane
Zip: 4101
Country: Australia

Facility:
Name: Site BE32003

Address:
City: Brussels
Zip: 1200
Country: Belgium

Facility:
Name: Site BE32002

Address:
City: Ghent
Zip: 9000
Country: Belgium

Facility:
Name: Site BE32001

Address:
City: Liege
Zip: 4000
Country: Belgium

Facility:
Name: Site BE32007

Address:
City: Lueven
Zip: 3000
Country: Belgium

Facility:
Name: Site BE32006

Address:
City: Roeselare
Zip: 8800
Country: Belgium

Facility:
Name: Site CA11004

Address:
City: Calgary
Zip: T2N 4N2
Country: Canada

Facility:
Name: Site CA11003

Address:
City: Edmonton
Zip: T6G 1Z2
Country: Canada

Facility:
Name: Site CA11006

Address:
City: Vancouver
Zip: V5Z 4E6
Country: Canada

Facility:
Name: Site CA11002

Address:
City: Hamilton
Zip: L8V 1C3
Country: Canada

Facility:
Name: Site CA11009

Address:
City: London
Zip: N6A 5A5
Country: Canada

Facility:
Name: Site CA11011

Address:
City: Oshawa
Zip: L1G 2B9
Country: Canada

Facility:
Name: Site CA11012

Address:
City: Toronto
Zip: M4N 3M5
Country: Canada

Facility:
Name: Site CA11005

Address:
City: Toronto
Zip: M5G 2M9
Country: Canada

Facility:
Name: Site CA11010

Address:
City: Montreal
Zip: H2X 0A9
Country: Canada

Facility:
Name: Site CA11001

Address:
City: Montreal
Zip: H3T 1E2
Country: Canada

Facility:
Name: Site CA11008

Address:
City: Quebec
Zip: G1R 2J6
Country: Canada

Facility:
Name: Site CN86009

Address:
City: Beijing City
Zip: 100021
Country: China

Facility:
Name: Site CN86001

Address:
City: Beijing
Zip: 100036
Country: China

Facility:
Name: Site CN86004

Address:
City: Beijing
Zip: 100050
Country: China

Facility:
Name: Site CN86005

Address:
City: Beijing
Zip: 100191
Country: China

Facility:
Name: Site CN86015

Address:
City: Bengbu
Zip: 233000
Country: China

Facility:
Name: Site CN86003

Address:
City: Changchun
Zip: 130021
Country: China

Facility:
Name: Site CN86006

Address:
City: Changsha
Zip: 410013
Country: China

Facility:
Name: Site CN86016

Address:
City: Changsha
Zip: 410013
Country: China

Facility:
Name: Site CN86010

Address:
City: Chengdu
Zip: 610041
Country: China

Facility:
Name: Site CN86024

Address:
City: Chongqing
Zip: 400030
Country: China

Facility:
Name: Site CN86007

Address:
City: Chongqing
Zip: 400038
Country: China

Facility:
Name: Site CN86028

Address:
City: Fuzhou
Zip: 350005
Country: China

Facility:
Name: Site CN86002

Address:
City: Guangzhou
Zip: 510120
Country: China

Facility:
Name: Site CN86020

Address:
City: Gunagzhou
Zip: 510280
Country: China

Facility:
Name: Site CN86018

Address:
City: Hangzhou
Zip: 0571
Country: China

Facility:
Name: Site CN86013

Address:
City: Hangzhou
Zip: 310014
Country: China

Facility:
Name: Site CN86022

Address:
City: Hangzhou
Zip: 310016
Country: China

Facility:
Name: Site CN86025

Address:
City: Hefei
Zip: 400030
Country: China

Facility:
Name: Site CN86027

Address:
City: Jinan
Zip: 250021
Country: China

Facility:
Name: Site CN86017

Address:
City: Nanjing
Zip: 210008
Country: China

Facility:
Name: Site CN86012

Address:
City: Nanjing
Zip: 210029
Country: China

Facility:
Name: Site CN86021

Address:
City: Ningbo
Zip: 315016
Country: China

Facility:
Name: Site CN86014

Address:
City: Shanghai
Zip: 200040
Country: China

Facility:
Name: Site CN86011

Address:
City: Shenyang City
Zip: 110022
Country: China

Facility:
Name: Site CN86023

Address:
City: Tianjin
Zip: 300052
Country: China

Facility:
Name: Site CN86019

Address:
City: Tianjin
Zip: 453000
Country: China

Facility:
Name: Site CN86029

Address:
City: Wenzhou
Zip: 325000
Country: China

Facility:
Name: Site CN86008

Address:
City: Wuhan City
Zip: 430030
Country: China

Facility:
Name: Site CN86030

Address:
City: Xicheng District
Zip: 100034
Country: China

Facility:
Name: Site CN86026

Address:
City: Xuzhou
Zip: 221009
Country: China

Facility:
Name: Site CZ42006

Address:
City: Brno
Zip: 656 91
Country: Czechia

Facility:
Name: Site CZ42001

Address:
City: Hradec Kralove
Zip: 500 05
Country: Czechia

Facility:
Name: Site CZ42004

Address:
City: Olomouc
Zip: 779 00
Country: Czechia

Facility:
Name: Site CZ42005

Address:
City: Praha 4-Krc
Zip: 140 59
Country: Czechia

Facility:
Name: Site DK45001

Address:
City: Aalborg
Zip: 9100
Country: Denmark

Facility:
Name: Site DK45003

Address:
City: Aarhus N
Zip: 8200
Country: Denmark

Facility:
Name: Site FR33014

Address:
City: Bordeaux
Zip: 33000
Country: France

Facility:
Name: Site FR33016

Address:
City: Lyon
Zip: 69373
Country: France

Facility:
Name: Site FR33003

Address:
City: Nice Cedex 2
Zip: 06189
Country: France

Facility:
Name: Site FR33020

Address:
City: Pierre-Bénite
Zip: 69495
Country: France

Facility:
Name: Site FR33013

Address:
City: Strasbourg
Zip: 67200
Country: France

Facility:
Name: Site FR33017

Address:
City: TOURS Cedex 09
Zip: 37044
Country: France

Facility:
Name: Site FR33011

Address:
City: Villejuif-Cedex-France
Zip: 94805
Country: France

Facility:
Name: Site DE49003

Address:
City: Berlin
Zip: 10117
Country: Germany

Facility:
Name: Site DE49013

Address:
City: Bielefeld
Zip: 33611
Country: Germany

Facility:
Name: Site DE49016

Address:
City: Düsseldorf
Zip: 40225
Country: Germany

Facility:
Name: Site DE49014

Address:
City: Erlangen
Zip: 91054
Country: Germany

Facility:
Name: Site DE49011

Address:
City: Essen
Zip: 45147
Country: Germany

Facility:
Name: Site DE49007

Address:
City: Frankfurt am Main
Zip: 60488
Country: Germany

Facility:
Name: Site DE49015

Address:
City: Gottingen
Zip: 37099
Country: Germany

Facility:
Name: Site DE49005

Address:
City: Heidelberg
Zip: 69120
Country: Germany

Facility:
Name: Site DE49009

Address:
City: Herne
Zip: 44649
Country: Germany

Facility:
Name: Site DE49006

Address:
City: Jena
Zip: 07747
Country: Germany

Facility:
Name: Site DE49001

Address:
City: Lubeck
Zip: 23538
Country: Germany

Facility:
Name: Site DE49008

Address:
City: Magdeburg
Zip: 39120
Country: Germany

Facility:
Name: Site DE49012

Address:
City: Mannheim
Zip: 68167
Country: Germany

Facility:
Name: Site DE49002

Address:
City: Munchen
Zip: 81675
Country: Germany

Facility:
Name: Site DE49004

Address:
City: Tübingen
Zip: 72076
Country: Germany

Facility:
Name: Site DE49010

Address:
City: Ulm
Zip: 89081
Country: Germany

Facility:
Name: Site HU36003

Address:
City: Budapest
Zip: 1083
Country: Hungary

Facility:
Name: Site HU36002

Address:
City: Budapest
Zip: 1122
Country: Hungary

Facility:
Name: Site HU36006

Address:
City: Debrecen
Zip: 4032
Country: Hungary

Facility:
Name: Site HU36001

Address:
City: Nyiregyhaza
Zip: 4400
Country: Hungary

Facility:
Name: Site HU36005

Address:
City: Szolnok
Zip: 5004
Country: Hungary

Facility:
Name: Site IL97203

Address:
City: Beer Sheva
Zip: 84101
Country: Israel

Facility:
Name: Site IL97201

Address:
City: Haifa
Zip: 31096
Country: Israel

Facility:
Name: Site IL97209

Address:
City: Holon
Zip: 58100
Country: Israel

Facility:
Name: Site IL97206

Address:
City: Jerusalem
Zip: 91120
Country: Israel

Facility:
Name: Site IL97202

Address:
City: Kfar Saba
Zip: 44281
Country: Israel

Facility:
Name: Site IL97208

Address:
City: Petach Tikva
Zip: 49414
Country: Israel

Facility:
Name: Site IL97211

Address:
City: Rehovot
Zip: 76100
Country: Israel

Facility:
Name: Site IL97210

Address:
City: Tel Aviv
Zip: 64239
Country: Israel

Facility:
Name: Site IL97204

Address:
City: Tel Hashomer
Zip: 52621
Country: Israel

Facility:
Name: Site IL97205

Address:
City: Zerifin
Zip: 70300
Country: Israel

Facility:
Name: Site IT39005

Address:
City: Areezo
Zip: 52100
Country: Italy

Facility:
Name: Site IT39008

Address:
City: Candiolo
Zip: 10060
Country: Italy

Facility:
Name: Site IT39009

Address:
City: Cremona
Zip: 26100
Country: Italy

Facility:
Name: Site IT39006

Address:
City: Genova
Zip: 16132
Country: Italy

Facility:
Name: Site IT39003

Address:
City: Meldola
Zip: 47014
Country: Italy

Facility:
Name: Site IT39014

Address:
City: Milano
Zip: 20132
Country: Italy

Facility:
Name: Site IT39007

Address:
City: Milano
Zip: 20141
Country: Italy

Facility:
Name: Site IT39004

Address:
City: Pisa
Zip: 56126
Country: Italy

Facility:
Name: Site IT39002

Address:
City: Terni
Zip: 05100
Country: Italy

Facility:
Name: Site IT39011

Address:
City: Torrette
Zip: 60126
Country: Italy

Facility:
Name: Site IT39001

Address:
City: Verona
Zip: 37134
Country: Italy

Facility:
Name: Site JP81002

Address:
City: Bunkyo City
Country: Japan

Facility:
Name: Site JP81009

Address:
City: Chiba
Country: Japan

Facility:
Name: Site JP81018

Address:
City: Chiba
Country: Japan

Facility:
Name: Site JP81013

Address:
City: Fukuoka
Country: Japan

Facility:
Name: Site JP81020

Address:
City: Fukuoka
Country: Japan

Facility:
Name: Site JP81011

Address:
City: Hirosaki
Country: Japan

Facility:
Name: Site JP81006

Address:
City: Kawasaki-shi
Country: Japan

Facility:
Name: Site JP81001

Address:
City: Koto-ku
Country: Japan

Facility:
Name: Site JP81017

Address:
City: Kyoto
Country: Japan

Facility:
Name: Site JP81015

Address:
City: Niigata
Country: Japan

Facility:
Name: Site JP81005

Address:
City: Okayama
Country: Japan

Facility:
Name: Site JP81016

Address:
City: Osakasayama-Shi
Country: Japan

Facility:
Name: Site JP81008

Address:
City: Osaka
Country: Japan

Facility:
Name: Site JP81007

Address:
City: Sapporo
Country: Japan

Facility:
Name: Site JP81012

Address:
City: Sendai-city
Country: Japan

Facility:
Name: Site JP81014

Address:
City: Tokushima
Country: Japan

Facility:
Name: Site JP81019

Address:
City: Tokyo
Country: Japan

Facility:
Name: Site JP81003

Address:
City: Toyama
Country: Japan

Facility:
Name: Site JP81004

Address:
City: Tsukuba
Country: Japan

Facility:
Name: Site JP81010

Address:
City: Ube
Country: Japan

Facility:
Name: Site KR82001

Address:
City: Daejeon
Zip: 301-721
Country: Korea, Republic of

Facility:
Name: Site KR82002

Address:
City: Goyang-si
Zip: 10408
Country: Korea, Republic of

Facility:
Name: Site KR82008

Address:
City: Hwasun
Zip: 519-763
Country: Korea, Republic of

Facility:
Name: Site KR82004

Address:
City: Seongnam-si
Zip: 13605
Country: Korea, Republic of

Facility:
Name: Site KR82003

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Facility:
Name: Site KR82005

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: Site KR82007

Address:
City: Seoul
Zip: 135-710
Country: Korea, Republic of

Facility:
Name: Site KR82006

Address:
City: Seoul
Zip: 137-701
Country: Korea, Republic of

Facility:
Name: Site NL31005

Address:
City: Amsterdam, Noord-Holland
Zip: 1066 CX
Country: Netherlands

Facility:
Name: Site NL31002

Address:
City: Amsterdam
Zip: 1066 CX
Country: Netherlands

Facility:
Name: Site NL31001

Address:
City: Amsterdam
Zip: 1081 HV
Country: Netherlands

Facility:
Name: Site NL31007

Address:
City: Leeuwarden
Zip: 8934 AD
Country: Netherlands

Facility:
Name: Site NL31004

Address:
City: Nieuwegein
Zip: 3435 CM
Country: Netherlands

Facility:
Name: Site NL31003

Address:
City: Rotterdam
Zip: 3075 EA
Country: Netherlands

Facility:
Name: Site NL31006

Address:
City: Utrecht
Zip: 3584 CX
Country: Netherlands

Facility:
Name: Site PL48002

Address:
City: Warszawa
Zip: 01-748
Country: Poland

Facility:
Name: Site RU70016

Address:
City: Arkhangelsk
Zip: 163045
Country: Russian Federation

Facility:
Name: Site RU70013

Address:
City: Barnaul
Zip: 656049
Country: Russian Federation

Facility:
Name: Site RU70020

Address:
City: Ivanovo
Zip: 153040
Country: Russian Federation

Facility:
Name: Site RU70014

Address:
City: Krasnoyarsk
Zip: 660133
Country: Russian Federation

Facility:
Name: Site RU70006

Address:
City: Leningradskaya Oblast'
Zip: 188663
Country: Russian Federation

Facility:
Name: Site RU70004

Address:
City: Moscow
Zip: 105077
Country: Russian Federation

Facility:
Name: Site RU70011

Address:
City: Moscow
Zip: 123056
Country: Russian Federation

Facility:
Name: Site RU70003

Address:
City: Moscow
Zip: 125284
Country: Russian Federation

Facility:
Name: Site RU70017

Address:
City: Nizhniy Novgorod
Zip: 603074
Country: Russian Federation

Facility:
Name: Site RU70002

Address:
City: Omsk
Zip: 644013
Country: Russian Federation

Facility:
Name: Site RU70019

Address:
City: Pyatigorsk
Zip: 357502
Country: Russian Federation

Facility:
Name: Site RU70010

Address:
City: Saint Petersburg
Zip: 195271
Country: Russian Federation

Facility:
Name: Site RU70007

Address:
City: Saint Petersburg
Zip: 197082
Country: Russian Federation

Facility:
Name: Site RU70012

Address:
City: Saint-Petersburg
Zip: 197758
Country: Russian Federation

Facility:
Name: Site RU70009

Address:
City: Saransk
Zip: 430032
Country: Russian Federation

Facility:
Name: Site RU70008

Address:
City: St. Petersburg
Zip: 197758
Country: Russian Federation

Facility:
Name: Site RU70015

Address:
City: Tyumen
Zip: 625041
Country: Russian Federation

Facility:
Name: Site RU70005

Address:
City: Ufa
Zip: 450000
Country: Russian Federation

Facility:
Name: Site SG65001

Address:
City: Singapore
Zip: 119074
Country: Singapore

Facility:
Name: Site SG65002

Address:
City: Singapore
Zip: 169610
Country: Singapore

Facility:
Name: Site SG65003

Address:
City: Singapore
Zip: 308433
Country: Singapore

Facility:
Name: Site ES34017

Address:
City: Barcelona
Zip: 08003
Country: Spain

Facility:
Name: Site ES34010

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: Site ES34006

Address:
City: Barcelona
Zip: 08036
Country: Spain

Facility:
Name: Site ES34001

Address:
City: Barcelona
Zip: 08041
Country: Spain

Facility:
Name: Site ES34008

Address:
City: Barcelona
Zip: 08907
Country: Spain

Facility:
Name: Site ES34013

Address:
City: Cordoba
Zip: 14004
Country: Spain

Facility:
Name: Site ES34021

Address:
City: Lugo
Zip: 27003
Country: Spain

Facility:
Name: Site ES34018

Address:
City: Madrid
Zip: 28007
Country: Spain

Facility:
Name: Site ES34002

Address:
City: Madrid
Zip: 28034
Country: Spain

Facility:
Name: Site ES34003

Address:
City: Madrid
Zip: 28040
Country: Spain

Facility:
Name: Site ES34015

Address:
City: Madrid
Zip: 28041
Country: Spain

Facility:
Name: Site ES34004

Address:
City: Manresa
Zip: 08243
Country: Spain

Facility:
Name: Site ES34020

Address:
City: Pamplona
Zip: 31008
Country: Spain

Facility:
Name: Site ES34016

Address:
City: Sabadell
Zip: 08208
Country: Spain

Facility:
Name: Site ES34012

Address:
City: Santander
Zip: 39008
Country: Spain

Facility:
Name: Site ES34007

Address:
City: Sevilla
Zip: 41013
Country: Spain

Facility:
Name: Site ES34019

Address:
City: Valencia
Zip: 46009
Country: Spain

Facility:
Name: Site ES34009

Address:
City: Valencia
Zip: 46014
Country: Spain

Facility:
Name: Site CH41004

Address:
City: Basel
Zip: 4031
Country: Switzerland

Facility:
Name: Site CH41002

Address:
City: Bern
Zip: 3010
Country: Switzerland

Facility:
Name: Site CH41001

Address:
City: Chur
Zip: 7000
Country: Switzerland

Facility:
Name: Site CH41003

Address:
City: Winterthur
Zip: 8401
Country: Switzerland

Facility:
Name: Site TW88603

Address:
City: Kaohsiung
Zip: 83301
Country: Taiwan

Facility:
Name: Site TW88602

Address:
City: Kweishan
Zip: 333
Country: Taiwan

Facility:
Name: Site TW88607

Address:
City: Taichung
Zip: 40447
Country: Taiwan

Facility:
Name: Site TW88606

Address:
City: Taichung
Zip: 40705
Country: Taiwan

Facility:
Name: Site TW88604

Address:
City: Tainan
Zip: 70403
Country: Taiwan

Facility:
Name: Site TW88605

Address:
City: Taipei
Zip: 10002
Country: Taiwan

Facility:
Name: Site TW88601

Address:
City: Taipei
Zip: 11217
Country: Taiwan

Facility:
Name: Site TH66004

Address:
City: Bangkok
Zip: 10330
Country: Thailand

Facility:
Name: Site TH66003

Address:
City: Bangkok
Zip: 10400
Country: Thailand

Facility:
Name: Site TH66005

Address:
City: Chiang Mai
Zip: 50200
Country: Thailand

Facility:
Name: Site TH66002

Address:
City: HatYai
Zip: 90110
Country: Thailand

Facility:
Name: Site TH66006

Address:
City: Krung Thep Maha Nakhon
Zip: 10700
Country: Thailand

Facility:
Name: Site TH66007

Address:
City: Muang
Zip: 40002
Country: Thailand

Facility:
Name: Site TH66001

Address:
City: Ratchathewi
Zip: 10400
Country: Thailand

Facility:
Name: Site TR90007

Address:
City: Ankara
Zip: 6100
Country: Turkey

Facility:
Name: Site TR90009

Address:
City: Ankara
Zip: 6230
Country: Turkey

Facility:
Name: Site TR90005

Address:
City: Antalya
Zip: 07059
Country: Turkey

Facility:
Name: Site TR90004

Address:
City: Edirne
Zip: 22030
Country: Turkey

Facility:
Name: Site TR90008

Address:
City: Istanbul
Zip: 34093
Country: Turkey

Facility:
Name: Site TR90003

Address:
City: Istanbul
Zip: 34214
Country: Turkey

Facility:
Name: Site TR90002

Address:
City: Istanbul
Zip: 81450
Country: Turkey

Facility:
Name: Site TR90001

Address:
City: Konya
Zip: 42080
Country: Turkey

Facility:
Name: Site TR90006

Address:
City: Malatya
Zip: 44280
Country: Turkey

Facility:
Name: Site UK44005

Address:
City: Glasgow
Zip: G12 0YN
Country: United Kingdom

Facility:
Name: Site UK44001

Address:
City: London
Zip: EC1M 6BQ
Country: United Kingdom

Facility:
Name: Site UK44009

Address:
City: London
Zip: W6 8RF
Country: United Kingdom

Facility:
Name: Site UK44006

Address:
City: Oxford
Zip: OX3 7LE
Country: United Kingdom

Facility:
Name: Site UK44010

Address:
City: Plymouth
Zip: PL6 8DH
Country: United Kingdom

Facility:
Name: Site UK44002

Address:
City: Preston
Zip: PR2 9HT
Country: United Kingdom

Facility:
Name: Site UK44003

Address:
City: Sheffield
Zip: S10 2RX
Country: United Kingdom

Facility:
Name: Site UK44008

Address:
City: Southampton
Zip: SO16 6YD
Country: United Kingdom

Start date: March 30, 2020

Completion date: November 30, 2027

Lead sponsor:
Agency: Astellas Pharma Global Development, Inc.
Agency class: Industry

Collaborator:
Agency: Merck Sharp & Dohme LLC
Agency class: Industry

Collaborator:
Agency: Seagen Inc.
Agency class: Industry

Source: Astellas Pharma Inc

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT04223856