Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04223856




Registration number
NCT04223856
Ethics application status
Date submitted
6/01/2020
Date registered
10/01/2020

Titles & IDs
Public title
Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
Scientific 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
Secondary ID [1] 0 0
2019-004542-15
Secondary ID [2] 0 0
SGN22E-003
Universal Trial Number (UTN)
Trial acronym
EV-302
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urothelial Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Enfortumab vedotin
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Gemcitabine

Experimental: Arm A - Enfortumab vedotin + pembrolizumab

Active comparator: Arm B - Gemcitabine + cisplatin or carboplatin

Experimental: Arm C (Not Recruiting) - Enfortumab vedotin + pembrolizumab + Cisplatin or carboplatin


Treatment: Drugs: Enfortumab vedotin
Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle

Treatment: Drugs: Pembrolizumab
IV infusion on Day 1 of every 3-week cycle

Treatment: Drugs: Cisplatin
administered as IV infusion on Day 1 of each 3-week cycle

Treatment: Drugs: Carboplatin
Dosed according to local guidelines and will be administered as IV infusion on Day 1 of each 3-week cycle

Treatment: Drugs: Gemcitabine
IV infusion on Days 1 and 8 of every 3 week cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Up to approximately 5 years
Primary outcome [2] 0 0
Duration of Overall survival (OS) (Arms A and B only, global population)
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Objective response rate (ORR) per RECIST v1.1 by BICR (Arms A and B only)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
Time to pain progression (TTPP) (Arms A and B only)
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [3] 0 0
Mean change from baseline in worst pain at Week 26 (Arms A and B only)
Timepoint [3] 0 0
Up to approximately 6 months
Secondary outcome [4] 0 0
Duration of PFS per RECIST v1.1 by investigator assessment (Arms A and B only)
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
ORR per RECIST v1.1 by investigator assessment (Arms A and B only)
Timepoint [5] 0 0
Up to approximately 5 years
Secondary outcome [6] 0 0
Duration of response (DOR) per RECIST v1.1 by BICR (Arms A and B only)
Timepoint [6] 0 0
Up to approximately 5 years
Secondary outcome [7] 0 0
DOR per RECIST v1.1 by investigator assessment (Arms A and B only)
Timepoint [7] 0 0
Up to approximately 5 years
Secondary outcome [8] 0 0
Disease control rate (DCR) per RECIST v1.1 by BICR (Arms A and B only)
Timepoint [8] 0 0
Up to approximately 5 years
Secondary outcome [9] 0 0
DCR per RECIST v1.1 by investigator assessment (Arms A and B only)
Timepoint [9] 0 0
Up to approximately 5 years
Secondary outcome [10] 0 0
Change from baseline in patient reported outcome assessment measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L)
Timepoint [10] 0 0
Up to approximately 5 years
Secondary outcome [11] 0 0
Mean scores in patient reported outcome assessment measured by the EQ-5D-5L
Timepoint [11] 0 0
Up to approximately 5 years
Secondary outcome [12] 0 0
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)
Timepoint [12] 0 0
Up to approximately 5 years
Secondary outcome [13] 0 0
Mean scores in patient reported outcome assessment measured by EORTC QLQ-C30
Timepoint [13] 0 0
Up to approximately 5 years
Secondary outcome [14] 0 0
Incidence of adverse events (AEs)
Timepoint [14] 0 0
Up to approximately 5 years
Secondary outcome [15] 0 0
Incidence of laboratory abnormalities
Timepoint [15] 0 0
Up to approximately 5 years
Secondary outcome [16] 0 0
Treatment discontinuation rate due to AEs
Timepoint [16] 0 0
Up to approximately 5 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2027
Actual
Sample size
Target
Accrual to date
Final
1030
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site AU61003 - Box Hill
Recruitment hospital [2] 0 0
Site AUS61001 - Douglas
Recruitment hospital [3] 0 0
Site AUS61004 - Heidelberg
Recruitment hospital [4] 0 0
Site AUS61002 - Macquarie Park
Recruitment hospital [5] 0 0
Site AUS61006 - South Australia
Recruitment hospital [6] 0 0
Site AU61005 - South Brisbane
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
4814 - Douglas
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [5] 0 0
5112 - South Australia
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maine
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New Mexico
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
Argentina
State/province [23] 0 0
Buenos Aire
Country [24] 0 0
Argentina
State/province [24] 0 0
Caba
Country [25] 0 0
Argentina
State/province [25] 0 0
Cordoba
Country [26] 0 0
Argentina
State/province [26] 0 0
La Rioja
Country [27] 0 0
Argentina
State/province [27] 0 0
Mendoza
Country [28] 0 0
Argentina
State/province [28] 0 0
Rosario
Country [29] 0 0
Argentina
State/province [29] 0 0
San Miguel
Country [30] 0 0
Argentina
State/province [30] 0 0
Tucuman
Country [31] 0 0
Argentina
State/province [31] 0 0
Viedma
Country [32] 0 0
Belgium
State/province [32] 0 0
Brussels
Country [33] 0 0
Belgium
State/province [33] 0 0
Ghent
Country [34] 0 0
Belgium
State/province [34] 0 0
Liege
Country [35] 0 0
Belgium
State/province [35] 0 0
Lueven
Country [36] 0 0
Belgium
State/province [36] 0 0
Roeselare
Country [37] 0 0
Canada
State/province [37] 0 0
Alberta
Country [38] 0 0
Canada
State/province [38] 0 0
British Columbia
Country [39] 0 0
Canada
State/province [39] 0 0
Ontario
Country [40] 0 0
Canada
State/province [40] 0 0
Quebec
Country [41] 0 0
China
State/province [41] 0 0
Beijing City
Country [42] 0 0
China
State/province [42] 0 0
Beijing
Country [43] 0 0
China
State/province [43] 0 0
Bengbu
Country [44] 0 0
China
State/province [44] 0 0
Changchun
Country [45] 0 0
China
State/province [45] 0 0
Changsha
Country [46] 0 0
China
State/province [46] 0 0
Chengdu
Country [47] 0 0
China
State/province [47] 0 0
Chongqing
Country [48] 0 0
China
State/province [48] 0 0
Fuzhou
Country [49] 0 0
China
State/province [49] 0 0
Guangzhou
Country [50] 0 0
China
State/province [50] 0 0
Gunagzhou
Country [51] 0 0
China
State/province [51] 0 0
Hangzhou
Country [52] 0 0
China
State/province [52] 0 0
Hefei
Country [53] 0 0
China
State/province [53] 0 0
Jinan
Country [54] 0 0
China
State/province [54] 0 0
Nanjing
Country [55] 0 0
China
State/province [55] 0 0
Ningbo
Country [56] 0 0
China
State/province [56] 0 0
Shanghai
Country [57] 0 0
China
State/province [57] 0 0
Shenyang City
Country [58] 0 0
China
State/province [58] 0 0
Tianjin
Country [59] 0 0
China
State/province [59] 0 0
Wenzhou
Country [60] 0 0
China
State/province [60] 0 0
Wuhan City
Country [61] 0 0
China
State/province [61] 0 0
Xicheng District
Country [62] 0 0
China
State/province [62] 0 0
Xuzhou
Country [63] 0 0
Czechia
State/province [63] 0 0
Brno
Country [64] 0 0
Czechia
State/province [64] 0 0
Hradec Kralove
Country [65] 0 0
Czechia
State/province [65] 0 0
Olomouc
Country [66] 0 0
Czechia
State/province [66] 0 0
Praha 4-Krc
Country [67] 0 0
Denmark
State/province [67] 0 0
Aalborg
Country [68] 0 0
Denmark
State/province [68] 0 0
Aarhus N
Country [69] 0 0
France
State/province [69] 0 0
Bordeaux
Country [70] 0 0
France
State/province [70] 0 0
Lyon
Country [71] 0 0
France
State/province [71] 0 0
Nice Cedex 2
Country [72] 0 0
France
State/province [72] 0 0
Pierre-Bénite
Country [73] 0 0
France
State/province [73] 0 0
Strasbourg
Country [74] 0 0
France
State/province [74] 0 0
TOURS Cedex 09
Country [75] 0 0
France
State/province [75] 0 0
Villejuif-Cedex-France
Country [76] 0 0
Germany
State/province [76] 0 0
Berlin
Country [77] 0 0
Germany
State/province [77] 0 0
Bielefeld
Country [78] 0 0
Germany
State/province [78] 0 0
Düsseldorf
Country [79] 0 0
Germany
State/province [79] 0 0
Erlangen
Country [80] 0 0
Germany
State/province [80] 0 0
Essen
Country [81] 0 0
Germany
State/province [81] 0 0
Frankfurt am Main
Country [82] 0 0
Germany
State/province [82] 0 0
Gottingen
Country [83] 0 0
Germany
State/province [83] 0 0
Heidelberg
Country [84] 0 0
Germany
State/province [84] 0 0
Herne
Country [85] 0 0
Germany
State/province [85] 0 0
Jena
Country [86] 0 0
Germany
State/province [86] 0 0
Lubeck
Country [87] 0 0
Germany
State/province [87] 0 0
Magdeburg
Country [88] 0 0
Germany
State/province [88] 0 0
Mannheim
Country [89] 0 0
Germany
State/province [89] 0 0
Munchen
Country [90] 0 0
Germany
State/province [90] 0 0
Tübingen
Country [91] 0 0
Germany
State/province [91] 0 0
Ulm
Country [92] 0 0
Hungary
State/province [92] 0 0
Budapest
Country [93] 0 0
Hungary
State/province [93] 0 0
Debrecen
Country [94] 0 0
Hungary
State/province [94] 0 0
Nyiregyhaza
Country [95] 0 0
Hungary
State/province [95] 0 0
Szolnok
Country [96] 0 0
Israel
State/province [96] 0 0
Beer Sheva
Country [97] 0 0
Israel
State/province [97] 0 0
Haifa
Country [98] 0 0
Israel
State/province [98] 0 0
Holon
Country [99] 0 0
Israel
State/province [99] 0 0
Jerusalem
Country [100] 0 0
Israel
State/province [100] 0 0
Kfar Saba
Country [101] 0 0
Israel
State/province [101] 0 0
Petach Tikva
Country [102] 0 0
Israel
State/province [102] 0 0
Rehovot
Country [103] 0 0
Israel
State/province [103] 0 0
Tel Aviv
Country [104] 0 0
Israel
State/province [104] 0 0
Tel Hashomer
Country [105] 0 0
Israel
State/province [105] 0 0
Zerifin
Country [106] 0 0
Italy
State/province [106] 0 0
Areezo
Country [107] 0 0
Italy
State/province [107] 0 0
Candiolo
Country [108] 0 0
Italy
State/province [108] 0 0
Cremona
Country [109] 0 0
Italy
State/province [109] 0 0
Genova
Country [110] 0 0
Italy
State/province [110] 0 0
Meldola
Country [111] 0 0
Italy
State/province [111] 0 0
Milano
Country [112] 0 0
Italy
State/province [112] 0 0
Pisa
Country [113] 0 0
Italy
State/province [113] 0 0
Terni
Country [114] 0 0
Italy
State/province [114] 0 0
Torrette
Country [115] 0 0
Italy
State/province [115] 0 0
Verona
Country [116] 0 0
Japan
State/province [116] 0 0
Bunkyo City
Country [117] 0 0
Japan
State/province [117] 0 0
Chiba
Country [118] 0 0
Japan
State/province [118] 0 0
Fukuoka
Country [119] 0 0
Japan
State/province [119] 0 0
Hirosaki
Country [120] 0 0
Japan
State/province [120] 0 0
Kawasaki-shi
Country [121] 0 0
Japan
State/province [121] 0 0
Koto-ku
Country [122] 0 0
Japan
State/province [122] 0 0
Kyoto
Country [123] 0 0
Japan
State/province [123] 0 0
Niigata
Country [124] 0 0
Japan
State/province [124] 0 0
Okayama
Country [125] 0 0
Japan
State/province [125] 0 0
Osakasayama-Shi
Country [126] 0 0
Japan
State/province [126] 0 0
Osaka
Country [127] 0 0
Japan
State/province [127] 0 0
Sapporo
Country [128] 0 0
Japan
State/province [128] 0 0
Sendai-city
Country [129] 0 0
Japan
State/province [129] 0 0
Tokushima
Country [130] 0 0
Japan
State/province [130] 0 0
Tokyo
Country [131] 0 0
Japan
State/province [131] 0 0
Toyama
Country [132] 0 0
Japan
State/province [132] 0 0
Tsukuba
Country [133] 0 0
Japan
State/province [133] 0 0
Ube
Country [134] 0 0
Korea, Republic of
State/province [134] 0 0
Daejeon
Country [135] 0 0
Korea, Republic of
State/province [135] 0 0
Goyang-si
Country [136] 0 0
Korea, Republic of
State/province [136] 0 0
Hwasun
Country [137] 0 0
Korea, Republic of
State/province [137] 0 0
Seongnam-si
Country [138] 0 0
Korea, Republic of
State/province [138] 0 0
Seoul
Country [139] 0 0
Netherlands
State/province [139] 0 0
Amsterdam, Noord-Holland
Country [140] 0 0
Netherlands
State/province [140] 0 0
Amsterdam
Country [141] 0 0
Netherlands
State/province [141] 0 0
Leeuwarden
Country [142] 0 0
Netherlands
State/province [142] 0 0
Nieuwegein
Country [143] 0 0
Netherlands
State/province [143] 0 0
Rotterdam
Country [144] 0 0
Netherlands
State/province [144] 0 0
Utrecht
Country [145] 0 0
Poland
State/province [145] 0 0
Warszawa
Country [146] 0 0
Russian Federation
State/province [146] 0 0
Arkhangelsk
Country [147] 0 0
Russian Federation
State/province [147] 0 0
Barnaul
Country [148] 0 0
Russian Federation
State/province [148] 0 0
Ivanovo
Country [149] 0 0
Russian Federation
State/province [149] 0 0
Krasnoyarsk
Country [150] 0 0
Russian Federation
State/province [150] 0 0
Leningradskaya Oblast'
Country [151] 0 0
Russian Federation
State/province [151] 0 0
Moscow
Country [152] 0 0
Russian Federation
State/province [152] 0 0
Nizhniy Novgorod
Country [153] 0 0
Russian Federation
State/province [153] 0 0
Omsk
Country [154] 0 0
Russian Federation
State/province [154] 0 0
Pyatigorsk
Country [155] 0 0
Russian Federation
State/province [155] 0 0
Saint Petersburg
Country [156] 0 0
Russian Federation
State/province [156] 0 0
Saint-Petersburg
Country [157] 0 0
Russian Federation
State/province [157] 0 0
Saransk
Country [158] 0 0
Russian Federation
State/province [158] 0 0
St. Petersburg
Country [159] 0 0
Russian Federation
State/province [159] 0 0
Tyumen
Country [160] 0 0
Russian Federation
State/province [160] 0 0
Ufa
Country [161] 0 0
Singapore
State/province [161] 0 0
Singapore
Country [162] 0 0
Spain
State/province [162] 0 0
Barcelona
Country [163] 0 0
Spain
State/province [163] 0 0
Cordoba
Country [164] 0 0
Spain
State/province [164] 0 0
Lugo
Country [165] 0 0
Spain
State/province [165] 0 0
Madrid
Country [166] 0 0
Spain
State/province [166] 0 0
Manresa
Country [167] 0 0
Spain
State/province [167] 0 0
Pamplona
Country [168] 0 0
Spain
State/province [168] 0 0
Sabadell
Country [169] 0 0
Spain
State/province [169] 0 0
Santander
Country [170] 0 0
Spain
State/province [170] 0 0
Sevilla
Country [171] 0 0
Spain
State/province [171] 0 0
Valencia
Country [172] 0 0
Switzerland
State/province [172] 0 0
Basel
Country [173] 0 0
Switzerland
State/province [173] 0 0
Bern
Country [174] 0 0
Switzerland
State/province [174] 0 0
Chur
Country [175] 0 0
Switzerland
State/province [175] 0 0
Winterthur
Country [176] 0 0
Taiwan
State/province [176] 0 0
Kaohsiung
Country [177] 0 0
Taiwan
State/province [177] 0 0
Kweishan
Country [178] 0 0
Taiwan
State/province [178] 0 0
Taichung
Country [179] 0 0
Taiwan
State/province [179] 0 0
Tainan
Country [180] 0 0
Taiwan
State/province [180] 0 0
Taipei
Country [181] 0 0
Thailand
State/province [181] 0 0
Bangkok
Country [182] 0 0
Thailand
State/province [182] 0 0
Chiang Mai
Country [183] 0 0
Thailand
State/province [183] 0 0
HatYai
Country [184] 0 0
Thailand
State/province [184] 0 0
Krung Thep Maha Nakhon
Country [185] 0 0
Thailand
State/province [185] 0 0
Muang
Country [186] 0 0
Thailand
State/province [186] 0 0
Ratchathewi
Country [187] 0 0
Turkey
State/province [187] 0 0
Ankara
Country [188] 0 0
Turkey
State/province [188] 0 0
Antalya
Country [189] 0 0
Turkey
State/province [189] 0 0
Edirne
Country [190] 0 0
Turkey
State/province [190] 0 0
Istanbul
Country [191] 0 0
Turkey
State/province [191] 0 0
Konya
Country [192] 0 0
Turkey
State/province [192] 0 0
Malatya
Country [193] 0 0
United Kingdom
State/province [193] 0 0
Glasgow
Country [194] 0 0
United Kingdom
State/province [194] 0 0
London
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Oxford
Country [196] 0 0
United Kingdom
State/province [196] 0 0
Plymouth
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Preston
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Sheffield
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Global Development, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Seagen Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Zejing Wang, MD, PhD
Address 0 0
Seagen Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Seagen Inc. Trial Information Support
Address 0 0
Country 0 0
Phone 0 0
866-333-7436
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04223856