Clinical trial NCT04223856: Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Urothelial Cancer
Keywords: Urothelial Cancer
Enfortumab vedotin
metastatic urothelial cancer
pembrolizumab
locally advanced urothelial cancer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
name: Seagen Inc.
First posted: 2020-01-10
Enrollment: 886
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Blinded Independent Central Review (BICR)
timeFrame: 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)
measure: Overall Survival (OS)
timeFrame: 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 outcomes:
measure: Percentage of Participants With Objective Response Rate (ORR) Per RECIST v1.1 by BICR
timeFrame: From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years)
measure: Time to Pain Progression (TTPP)
timeFrame: From the date of randomization to date of pain progression (maximum up to approximately 7.4 years)
measure: Change From Baseline in Worst Pain Using BPI-SF at Week 26
timeFrame: Baseline, Week 26
measure: PFS Per RECIST v1.1 by Investigator Assessment
timeFrame: 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)
measure: ORR Per RECIST v1.1 by Investigator Assessment
timeFrame: From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years)
measure: Duration of Response (DOR) Per RECIST v1.1 by BICR
timeFrame: 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)
measure: DOR Per RECIST v1.1 by Investigator Assessment
timeFrame: 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)
measure: Disease Control Rate (DCR) Per RECIST v1.1 by BICR
timeFrame: 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)
measure: DCR Per RECIST v1.1 by Investigator Assessment
timeFrame: 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)
measure: Mean Scores in Patient Reported Outcome (PRO) Assessment Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L)
timeFrame: End of study (approximately up to 7.4 years)
measure: Change From Baseline in PRO Assessment Measured by the EQ-5D-5L
timeFrame: Baseline, End of study (approximately up to 7.4 years)
measure: Mean Scores in PRO Assessment Measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
timeFrame: End of study (approximately up to 7.4 years)
measure: Change From Baseline in PRO Assessment Measured by EORTC QLQ-C30
timeFrame: Baseline, End of study (approximately up to 7.4 years)
measure: Number of Participants With Treatment Emergent Adverse Events Adverse Events (AEs)
timeFrame: From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)
measure: Number of Participants With Serious TEAE
timeFrame: From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)
measure: Number of Participants With Grade 3-5 TEAE
timeFrame: From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)
measure: Number of Participants Related to Treatment AEs
timeFrame: From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)
measure: Number of Participants With Laboratory Abnormalities
timeFrame: From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)
measure: Number of Participants With Treatment Discontinuation Rate Due to AEs
timeFrame: During study (approximately up to 7.4 years)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers - Chandler
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates PD - HOPE
state: Arizona
city: Burbank
country: United States
facility: Providence St Joseph Medical Center
state: California
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles Medical Center
state: California
city: Orange
country: United States
facility: University of California Irvine - Newport
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers - Aurora
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital / University of Colorado
state: Colorado
city: Denver
country: United States
facility: Cancer Centers of Colorado - Denver
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Norwich
country: United States
facility: Eastern CT Hematology and Oncology Associates
state: Connecticut
city: Washington
country: United States
facility: Lombardi Cancer Center / Georgetown University Medical Center
state: District of Columbia
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute / Emory University School of Medicine
state: Georgia
city: Marietta
country: United States
facility: Georgia Cancer Specialists / Northside Hospital Cancer Institute
state: Georgia
city: Metairie
country: United States
facility: Louisiana State University/ East Jefferson General Hospital
state: Louisiana
city: Biddeford
country: United States
facility: Maine Health Cancer Care
state: Maine
city: Baltimore
country: United States
facility: Johns Hopkins Medical Center
state: Maryland
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Albuquerque
country: United States
facility: New Mexico Cancer Center
state: New Mexico
city: New York
country: United States
facility: New York University (NYU) Cancer Institute
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Greenville
country: United States
facility: Vidant Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic Cancer Center
state: Ohio
city: Pittsburgh
country: United States
facility: Hillman Cancer Center / University of Pittsburgh Medical Center
state: Pennsylvania
city: Greenville
country: United States
facility: Saint Francis Hospital / Bon Secours - South Carolina
state: South Carolina
city: Germantown
country: United States
facility: West Cancer Center & Research Institute
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Tyler
country: United States
facility: UT Health East Texas Hope Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance / University of Washington
state: Washington
city: Buenos Aire
country: Argentina
facility: Site AR54008
city: Caba
country: Argentina
facility: Site AR54011
city: Cordoba
country: Argentina
facility: Site AR54005
city: La Rioja
country: Argentina
facility: Site AR54006
city: Mendoza
country: Argentina
facility: Site AR54004
city: Rosario
country: Argentina
facility: Site AR54001
city: San Miguel
country: Argentina
facility: Site AR54002
city: Tucuman
country: Argentina
facility: Site AR54012
city: Viedma
country: Argentina
facility: Site AR54003
city: Box Hill
country: Australia
facility: Site AU61003
city: Douglas
country: Australia
facility: Site AUS61001
city: Heidelberg
country: Australia
facility: Site AUS61004
city: Macquarie Park
country: Australia
facility: Site AUS61002
city: South Australia
country: Australia
facility: Site AUS61006
city: South Brisbane
country: Australia
facility: Site AU61005
city: Brussels
country: Belgium
facility: Site BE32003
city: Ghent
country: Belgium
facility: Site BE32002
city: Liege
country: Belgium
facility: Site BE32001
city: Lueven
country: Belgium
facility: Site BE32007
city: Roeselare
country: Belgium
facility: Site BE32006
city: Calgary
country: Canada
facility: Site CA11004
state: Alberta
city: Edmonton
country: Canada
facility: Site CA11003
state: Alberta
city: Vancouver
country: Canada
facility: Site CA11006
state: British Columbia
city: Hamilton
country: Canada
facility: Site CA11002
state: Ontario
city: London
country: Canada
facility: Site CA11009
state: Ontario
city: Oshawa
country: Canada
facility: Site CA11011
state: Ontario
city: Toronto
country: Canada
facility: Site CA11012
state: Ontario
city: Toronto
country: Canada
facility: Site CA11005
state: Ontario
city: Montreal
country: Canada
facility: Site CA11010
state: Quebec
city: Montreal
country: Canada
facility: Site CA11001
state: Quebec
city: Quebec
country: Canada
facility: Site CA11008
city: Beijing City
country: China
facility: Site CN86009
city: Beijing
country: China
facility: Site CN86001
city: Beijing
country: China
facility: Site CN86004
city: Beijing
country: China
facility: Site CN86005
city: Bengbu
country: China
facility: Site CN86015
city: Changchun
country: China
facility: Site CN86003
city: Changsha
country: China
facility: Site CN86006
city: Changsha
country: China
facility: Site CN86016
city: Chengdu
country: China
facility: Site CN86010
city: Chongqing
country: China
facility: Site CN86024
city: Chongqing
country: China
facility: Site CN86007
city: Fuzhou
country: China
facility: Site CN86028
city: Guangzhou
country: China
facility: Site CN86002
city: Gunagzhou
country: China
facility: Site CN86020
city: Hangzhou
country: China
facility: Site CN86018
city: Hangzhou
country: China
facility: Site CN86013
city: Hangzhou
country: China
facility: Site CN86022
city: Hefei
country: China
facility: Site CN86025
city: Jinan
country: China
facility: Site CN86027
city: Nanjing
country: China
facility: Site CN86017
city: Nanjing
country: China
facility: Site CN86012
city: Ningbo
country: China
facility: Site CN86021
city: Shanghai
country: China
facility: Site CN86014
city: Shenyang City
country: China
facility: Site CN86011
city: Tianjin
country: China
facility: Site CN86023
city: Tianjin
country: China
facility: Site CN86019
city: Wenzhou
country: China
facility: Site CN86029
city: Wuhan City
country: China
facility: Site CN86008
city: Xicheng District
country: China
facility: Site CN86030
city: Xuzhou
country: China
facility: Site CN86026
city: Brno
country: Czechia
facility: Site CZ42006
city: Hradec Kralove
country: Czechia
facility: Site CZ42001
city: Olomouc
country: Czechia
facility: Site CZ42004
city: Praha 4-Krc
country: Czechia
facility: Site CZ42005
city: Aalborg
country: Denmark
facility: Site DK45001
city: Aarhus N
country: Denmark
facility: Site DK45003
city: Bordeaux
country: France
facility: Site FR33014
city: Lyon
country: France
facility: Site FR33016
city: Nice Cedex 2
country: France
facility: Site FR33003
city: Pierre-Bénite
country: France
facility: Site FR33020
city: Strasbourg
country: France
facility: Site FR33013
city: TOURS Cedex 09
country: France
facility: Site FR33017
city: Villejuif-Cedex-France
country: France
facility: Site FR33011
city: Berlin
country: Germany
facility: Site DE49003
city: Bielefeld
country: Germany
facility: Site DE49013
city: Düsseldorf
country: Germany
facility: Site DE49016
city: Erlangen
country: Germany
facility: Site DE49014
city: Essen
country: Germany
facility: Site DE49011
city: Frankfurt am Main
country: Germany
facility: Site DE49007
city: Gottingen
country: Germany
facility: Site DE49015
city: Heidelberg
country: Germany
facility: Site DE49005
city: Herne
country: Germany
facility: Site DE49009
city: Jena
country: Germany
facility: Site DE49006
city: Lubeck
country: Germany
facility: Site DE49001
city: Magdeburg
country: Germany
facility: Site DE49008
city: Mannheim
country: Germany
facility: Site DE49012
city: Munchen
country: Germany
facility: Site DE49002
city: Tübingen
country: Germany
facility: Site DE49004
city: Ulm
country: Germany
facility: Site DE49010
city: Budapest
country: Hungary
facility: Site HU36003
city: Budapest
country: Hungary
facility: Site HU36002
city: Debrecen
country: Hungary
facility: Site HU36006
city: Nyiregyhaza
country: Hungary
facility: Site HU36001
city: Szolnok
country: Hungary
facility: Site HU36005
city: Beer Sheva
country: Israel
facility: Site IL97203
city: Haifa
country: Israel
facility: Site IL97201
city: Holon
country: Israel
facility: Site IL97209
city: Jerusalem
country: Israel
facility: Site IL97206
city: Kfar Saba
country: Israel
facility: Site IL97202
city: Petach Tikva
country: Israel
facility: Site IL97208
city: Rehovot
country: Israel
facility: Site IL97211
city: Tel Aviv
country: Israel
facility: Site IL97210
city: Tel Hashomer
country: Israel
facility: Site IL97204
city: Zerifin
country: Israel
facility: Site IL97205
city: Areezo
country: Italy
facility: Site IT39005
city: Candiolo
country: Italy
facility: Site IT39008
city: Cremona
country: Italy
facility: Site IT39009
city: Genova
country: Italy
facility: Site IT39006
city: Meldola
country: Italy
facility: Site IT39003
city: Milano
country: Italy
facility: Site IT39014
city: Milano
country: Italy
facility: Site IT39007
city: Pisa
country: Italy
facility: Site IT39004
city: Terni
country: Italy
facility: Site IT39002
city: Torrette
country: Italy
facility: Site IT39011
city: Verona
country: Italy
facility: Site IT39001
city: Bunkyo City
country: Japan
facility: Site JP81002
city: Chiba
country: Japan
facility: Site JP81009
city: Chiba
country: Japan
facility: Site JP81018
city: Fukuoka
country: Japan
facility: Site JP81013
city: Fukuoka
country: Japan
facility: Site JP81020
city: Hirosaki
country: Japan
facility: Site JP81011
city: Kawasaki-shi
country: Japan
facility: Site JP81006
city: Koto-ku
country: Japan
facility: Site JP81001
city: Kyoto
country: Japan
facility: Site JP81017
city: Niigata
country: Japan
facility: Site JP81015
city: Okayama
country: Japan
facility: Site JP81005
city: Osakasayama-Shi
country: Japan
facility: Site JP81016
city: Osaka
country: Japan
facility: Site JP81008
city: Sapporo
country: Japan
facility: Site JP81007
city: Sendai-city
country: Japan
facility: Site JP81012
city: Tokushima
country: Japan
facility: Site JP81014
city: Tokyo
country: Japan
facility: Site JP81019
city: Toyama
country: Japan
facility: Site JP81003
city: Tsukuba
country: Japan
facility: Site JP81004
city: Ube
country: Japan
facility: Site JP81010
city: Daejeon
country: Korea, Republic of
facility: Site KR82001
city: Goyang-si
country: Korea, Republic of
facility: Site KR82002
city: Hwasun
country: Korea, Republic of
facility: Site KR82008
city: Seongnam-si
country: Korea, Republic of
facility: Site KR82004
city: Seoul
country: Korea, Republic of
facility: Site KR82003
city: Seoul
country: Korea, Republic of
facility: Site KR82005
city: Seoul
country: Korea, Republic of
facility: Site KR82007
city: Seoul
country: Korea, Republic of
facility: Site KR82006
city: Amsterdam, Noord-Holland
country: Netherlands
facility: Site NL31005
city: Amsterdam
country: Netherlands
facility: Site NL31002
city: Amsterdam
country: Netherlands
facility: Site NL31001
city: Leeuwarden
country: Netherlands
facility: Site NL31007
city: Nieuwegein
country: Netherlands
facility: Site NL31004
city: Rotterdam
country: Netherlands
facility: Site NL31003
city: Utrecht
country: Netherlands
facility: Site NL31006
city: Warszawa
country: Poland
facility: Site PL48002
city: Arkhangelsk
country: Russian Federation
facility: Site RU70016
city: Barnaul
country: Russian Federation
facility: Site RU70013
city: Ivanovo
country: Russian Federation
facility: Site RU70020
city: Krasnoyarsk
country: Russian Federation
facility: Site RU70014
city: Leningradskaya Oblast'
country: Russian Federation
facility: Site RU70006
city: Moscow
country: Russian Federation
facility: Site RU70004
city: Moscow
country: Russian Federation
facility: Site RU70011
city: Moscow
country: Russian Federation
facility: Site RU70003
city: Nizhniy Novgorod
country: Russian Federation
facility: Site RU70017
city: Omsk
country: Russian Federation
facility: Site RU70002
city: Pyatigorsk
country: Russian Federation
facility: Site RU70019
city: Saint Petersburg
country: Russian Federation
facility: Site RU70010
city: Saint Petersburg
country: Russian Federation
facility: Site RU70007
city: Saint-Petersburg
country: Russian Federation
facility: Site RU70012
city: Saransk
country: Russian Federation
facility: Site RU70009
city: St. Petersburg
country: Russian Federation
facility: Site RU70008
city: Tyumen
country: Russian Federation
facility: Site RU70015
city: Ufa
country: Russian Federation
facility: Site RU70005
city: Singapore
country: Singapore
facility: Site SG65001
city: Singapore
country: Singapore
facility: Site SG65002
city: Singapore
country: Singapore
facility: Site SG65003
city: Barcelona
country: Spain
facility: Site ES34017
city: Barcelona
country: Spain
facility: Site ES34010
city: Barcelona
country: Spain
facility: Site ES34006
city: Barcelona
country: Spain
facility: Site ES34001
city: Barcelona
country: Spain
facility: Site ES34008
city: Cordoba
country: Spain
facility: Site ES34013
city: Lugo
country: Spain
facility: Site ES34021
city: Madrid
country: Spain
facility: Site ES34018
city: Madrid
country: Spain
facility: Site ES34002
city: Madrid
country: Spain
facility: Site ES34003
city: Madrid
country: Spain
facility: Site ES34015
city: Manresa
country: Spain
facility: Site ES34004
city: Pamplona
country: Spain
facility: Site ES34020
city: Sabadell
country: Spain
facility: Site ES34016
city: Santander
country: Spain
facility: Site ES34012
city: Sevilla
country: Spain
facility: Site ES34007
city: Valencia
country: Spain
facility: Site ES34019
city: Valencia
country: Spain
facility: Site ES34009
city: Basel
country: Switzerland
facility: Site CH41004
city: Bern
country: Switzerland
facility: Site CH41002
city: Chur
country: Switzerland
facility: Site CH41001
city: Winterthur
country: Switzerland
facility: Site CH41003
city: Kaohsiung
country: Taiwan
facility: Site TW88603
city: Kweishan
country: Taiwan
facility: Site TW88602
city: Taichung
country: Taiwan
facility: Site TW88607
city: Taichung
country: Taiwan
facility: Site TW88606
city: Tainan
country: Taiwan
facility: Site TW88604
city: Taipei
country: Taiwan
facility: Site TW88605
city: Taipei
country: Taiwan
facility: Site TW88601
city: Bangkok
country: Thailand
facility: Site TH66004
city: Bangkok
country: Thailand
facility: Site TH66003
city: Chiang Mai
country: Thailand
facility: Site TH66005
city: HatYai
country: Thailand
facility: Site TH66002
city: Krung Thep Maha Nakhon
country: Thailand
facility: Site TH66006
city: Muang
country: Thailand
facility: Site TH66007
city: Ratchathewi
country: Thailand
facility: Site TH66001
city: Ankara
country: Turkey
facility: Site TR90007
city: Ankara
country: Turkey
facility: Site TR90009
city: Antalya
country: Turkey
facility: Site TR90005
city: Edirne
country: Turkey
facility: Site TR90004
city: Istanbul
country: Turkey
facility: Site TR90008
city: Istanbul
country: Turkey
facility: Site TR90003
city: Istanbul
country: Turkey
facility: Site TR90002
city: Konya
country: Turkey
facility: Site TR90001
city: Malatya
country: Turkey
facility: Site TR90006
city: Glasgow
country: United Kingdom
facility: Site UK44005
city: London
country: United Kingdom
facility: Site UK44001
city: London
country: United Kingdom
facility: Site UK44009
city: Oxford
country: United Kingdom
facility: Site UK44006
city: Plymouth
country: United Kingdom
facility: Site UK44010
city: Preston
country: United Kingdom
facility: Site UK44002
city: Sheffield
country: United Kingdom
facility: Site UK44003
city: Southampton
country: United Kingdom
facility: Site UK44008
Study officials:
affiliation: Seagen Inc.
name: Zejing Wang, MD, PhD
role: STUDY_DIRECTOR
affiliation: Seagen Inc.
name: John Lu, MD
role: STUDY_DIRECTOR
References:
citation: 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.