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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03474107




Registration number
NCT03474107
Ethics application status
Date submitted
16/03/2018
Date registered
22/03/2018
Date last updated
27/07/2020

Titles & IDs
Public title
A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
Scientific title
An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
Secondary ID [1] 0 0
7465-CL-0301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ureteral Cancer 0 0
Urothelial Cancer 0 0
Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - enfortumab vedotin
Treatment: Drugs - docetaxel
Treatment: Drugs - vinflunine
Treatment: Drugs - paclitaxel

Experimental: Arm A: enfortumab vedotin - Participants will receive enfortumab vedotin (EV) on days 1, 8 and 15 of each 28 day cycle.

Active Comparator: Arm B: chemotherapy - Participants will receive either docetaxel, vinflunine or paclitaxel as determined prior to participant's randomization. Participants will receive the assigned drug on day 1 of every 21 day cycle.


Treatment: Drugs: enfortumab vedotin
Intravenously (IV)

Treatment: Drugs: docetaxel
Intravenously (IV)

Treatment: Drugs: vinflunine
Intravenously (IV)

Treatment: Drugs: paclitaxel
IV infusion

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - OS is defined as the time from randomization to the date of death.
Timepoint [1] 0 0
Up to 36 months
Secondary outcome [1] 0 0
Progression Free Survival on study therapy (PFS1) per Response Evaluation Criteria In Solid Tumors (RECIST) V1.1 - PFS1 is defined as the time from the date of randomization until the date of radiological disease progression (per RECIST V1.1), or until death due to any cause.
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [2] 0 0
Overall Response Rate (ORR) (Complete Response (CR) and Partial Response(PR)) per RECIST V1.1 - The ORR is defined as the proportion of participants with a complete or partial objective response based on the RECIST V1.1.
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Disease Control Rate (DCR) (CR + PR + stable disease [SD]) per RECIST V1.1 - The DCR is defined as the proportion of participants with a complete or partial objective response or a stable disease based on RECIST V1.1.
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [4] 0 0
Duration of Response (DOR) per RECIST V1.1 - DOR is defined as the time from the date of the first response CR/PR per RECIST V1.1 (whichever is first recorded) that is subsequently confirmed as assessed by investigator to the date of radiological progression or date of death for participants who achieved CR or PR.
Timepoint [4] 0 0
Up to 24 months
Secondary outcome [5] 0 0
Safety assessed by Adverse Events (AEs) - Adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA).
Treatment Emergent Adverse Event (TEAE) is defined as an adverse event observed or worsened after starting administration of the study drug. The number and percentage of participants with treatment-emergent AEs, Serious Adverse Events (SAEs), AEs leading to withdrawal of treatment, and AEs related to study drug will be summarized by system organ class, preferred term and treatment group. The number and percentage of AEs by severity will also be summarized. All AEs will be listed. A study drug-related TEAE is defined as any TEAE with a causal relationship of YES by the investigator.
Timepoint [5] 0 0
Up to 25 months
Secondary outcome [6] 0 0
Number of participants with laboratory value abnormalities and/or adverse events - Number of participants with potentially clinically significant laboratory values.
Timepoint [6] 0 0
Up to 24 months
Secondary outcome [7] 0 0
Number of participants with vital signs abnormalities and/or adverse events - Number of participants with potentially clinically significant vital sign values.
Timepoint [7] 0 0
Up to 25 months
Secondary outcome [8] 0 0
Safety assessed by 12- lead electrocardiogram (ECG) - A standard 12-lead ECG will be performed and assessed using local standard procedures. Clinically significant abnormal findings at screening should be recorded as medical history.
Any abnormal ECGs, including those that worsen from baseline, that is considered to be clinically significant and not related to underlying disease, is to be reported as an (S)AE.
Timepoint [8] 0 0
Up to 24 months
Secondary outcome [9] 0 0
Safety assessed by Eastern Cooperative Oncology Group Performance Status (ECOG PS) - Summary statistics (number and percent of participants) for each category of the ECOG PS at each assessment will be provided. The change from baseline to final visit or early termination will also be summarized. Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
Timepoint [9] 0 0
Up to 25 months
Secondary outcome [10] 0 0
Patient reported outcome assessed by quality of life: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) - The QLQ-C30 was developed to measure aspects of Quality of Life (QoL) pertinent to participants with a broad range of cancers who are participating in clinical trials. The current version of the core instrument (QLQ-C30, Version 3) is a 30-item questionnaire consisting of the following: functional domains (physical, role, cognitive, emotional, social); 3 symptom scales (fatigue, pain, nausea & vomiting); single items for symptoms (shortness of breath, loss of appetite, sleep disturbance, constipation, diarrhea) and financial impact of the disease; and 2 global items (health, overall QoL). Questions 1-28 range from 1 (not at all) to 4 (very much); questions 29-30 range from 1 (very poor) to 7 (excellent).
Timepoint [10] 0 0
Up to 25 months
Secondary outcome [11] 0 0
Patient reported outcome assessed by quality of life: EuroQOL 5-dimensions (EQ-5D -5L) questionnaire - 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. Responses to the 5 items will also be converted to a weighted health state index (utility score) based on values derived from general population samples.
Timepoint [11] 0 0
Up to 25 months

Eligibility
Key inclusion criteria
- Subject is legally an adult according to local regulation at the time of signing
informed consent.

- Subject has histologically or cytologically confirmed urothelial carcinoma (i.e.,
cancer of the bladder, renal pelvis, ureter, or urethra). Subjects with urothelial
carcinoma (transitional cell) with squamous differentiation or mixed cell types are
eligible.

- Subject must have experienced radiographic progression or relapse during or after a
checkpoint inhibitor (CPI) (anti-programmed cell death protein 1 (PD1) or
anti-programmed death-ligand 1 (PD-L1)) for locally advanced or metastatic disease.
Subjects who discontinued CPI treatment due to toxicity are eligible provided that the
subjects have evidence of disease progression following discontinuation. The CPI need
not be the most recent therapy. Subjects for whom the most recent therapy has been a
non-CPI based regimen are eligible if the subjects have progressed/relapsed during or
after the subjects most recent therapy. Locally advanced disease must not be amenable
to resection with curative intent per the treating physician.

- Subject must have received a platinum containing regimen (cisplatin or carboplatin) in
the metastatic/locally advanced, neoadjuvant or adjuvant setting. If platinum was
administered in the adjuvant/neoadjuvant setting subject must have progressed within
12 months of completion.

- Subject has radiologically documented metastatic or locally advanced disease at
baseline.

- An archival tumor tissue sample should be available for submission to central
laboratory prior to study treatment. If an archival tumor tissue sample is not
available, a fresh tissue sample should be provided. If a fresh tissue sample cannot
be provided due to safety concerns, enrollment into the study must be discussed with
the medical monitor.

- Subject has ECOG PS of 0 or 1

- The subject has the following baseline laboratory data:

- absolute neutrophil count (ANC) = 1500/mm3

- platelet count = 100 × 109/L

- hemoglobin = 9 g/dL

- serum total bilirubin = 1.5 × upper limit of normal (ULN) or = 3 × ULN for
subjects with Gilbert's disease

- creatinine clearance (CrCl) = 30 mL/min as estimated per institutional standards
or as measured by 24 hour urine collection (glomerular filtration rate [GFR] can
also be used instead of CrCl)

- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 × ULN
or = 3 x ULN for subjects with liver metastases

- Female subject must either:

- Be of nonchildbearing potential: Postmenopausal (defined as at least 1 year
without any menses for which there is no other obvious pathological or
physiological cause) prior to screening, or documented surgically sterile (e.g.,
hysterectomy, bilateral salpingectomy, bilateral oophorectomy).

- Or, if of childbearing potential: Agree not to try to become pregnant during the
study and for at least 6 months after the final study drug administration, and
have a negative urine or serum pregnancy test within 7 days prior to Day 1
(Females with false positive results and documented verification of negative
pregnancy status are eligible for participation), and if heterosexually active,
agree to consistently use a condom plus 1 form of highly effective birth control
per locally accepted standards starting at screening and throughout the study
period and for at least 6 months after the final study administration.

- Female subject must agree not to breastfeed or donate ova starting at screening and
throughout the study period, and for at least 6 months after the final study drug
administration.

- A sexually active male subject with female partner(s) who is of childbearing potential
is eligible if:

- Agrees to use a male condom starting at screening and continue throughout the
study treatment and for at least 6 months after final study drug administration.
If the male subject has not had a vasectomy or is not sterile as defined below
the subjects female partner(s) is utilizing 1 form of highly effective birth
control per locally accepted standards starting at screening and continue
throughout study treatment and for at least 6 months after the male subject
receives final study drug administration.

- Male subject must not donate sperm starting at screening and throughout the study
period, and for at least 6 months after the final study drug administration.

- Male subject with a pregnant or breastfeeding partner(s) must agree to abstinence or
use a condom for the duration of the pregnancy or time partner is breastfeeding
throughout the study period and for at least 6 months after the final study drug
administration.

- Subject agrees not to participate in another interventional study while on treatment
in present study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject has preexisting sensory or motor neuropathy Grade = 2.

- Subject has active central nervous system (CNS) metastases. Subjects with treated CNS
metastases are permitted on study if all the following are true:

- CNS metastases have been clinically stable for at least 6 weeks prior to
screening

- If requiring steroid treatment for CNS metastases, the subject is on a stable
dose = 20 mg/day of prednisone or equivalent for at least 2 weeks

- Baseline scans show no evidence of new or enlarged brain metastasis

- Subject does not have leptomeningeal disease

- Subject has ongoing clinically significant toxicity (Grade 2 or higher with the
exception of alopecia) associated with prior treatment (including systemic therapy,
radiotherapy or surgery). Subject with = Grade 2 immunotherapy-related hypothyroidism
or panhypopituitarism may be enrolled when well-maintained/controlled on a stable dose
of hormone replacement therapy (if indicated). Subjects with ongoing = Grade 3
immunotherapy-related hypothyroidism or panhypopituitarism are excluded. Subjects with
ongoing immunotherapy related colitis, uveitis, or pneumonitis or subjects with other
immunotherapy related AEs requiring high doses of steroids (> 20 mg/day of prednisone
or equivalent) are excluded.

- Subject has prior treatment with EV or other monomethyl auristatin E (MMAE)-based
Antibody drug conjugates (ADCs).

- Subject has received prior chemotherapy for urothelial cancer with all available study
therapies in the control arm (i.e., both prior paclitaxel and docetaxel in regions
where vinflunine is not an approved therapy, or prior paclitaxel, docetaxel and
vinflunine in regions where vinflunine is an approved therapy).

- Subject has received more than 1 prior chemotherapy regimen for locally advanced or
metastatic urothelial cancer, including chemotherapy for adjuvant or neo-adjuvant
disease if recurrence occurred within 12 months of completing therapy. The
substitution of carboplatin for cisplatin does not constitute a new regimen provided
no new chemotherapeutic agents were added to the regimen.

- Subject has history of another malignancy within 3 years before the first dose of
study drug, or any evidence of residual disease from a previously diagnosed
malignancy. Subjects with nonmelanoma skin cancer, localized prostate cancer treated
with curative intent with no evidence of progression, low-risk or very low-risk (per
standard guidelines) localized prostate cancer under active surveillance/watchful
waiting without intent to treat, or carcinoma in situ of any type (if complete
resection was performed) are allowed.

- Subject is currently receiving systemic antimicrobial treatment for viral, bacterial,
or fungal infection at the time of first dose of EV. Routine antimicrobial prophylaxis
is permitted.

- Subject has known active Hepatitis B (e.g., hepatitis B surface antigen (HBsAg)
reactive) or active hepatitis C (e.g., hepatitis C virus (HCV) Ribonucleic Acid (RNA)
[qualitative] is detected).

- Subject has known history of human immunodeficiency virus (HIV) infection (HIV 1 or
2).

- Subject has documented history of a cerebral vascular event (stroke or transient
ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms
(including congestive heart failure) consistent with New York Heart Association Class
III-IV within 6 months prior to the first dose of study drug.

- Subject has radiotherapy or major surgery within 4 weeks prior to first dose of study
drug.

- Subject has had chemotherapy, biologics, investigational agents, and/or antitumor
treatment with immunotherapy that is not completed 2 weeks prior to first dose of
study drug.

- Subject has known hypersensitivity to EV or to any excipient contained in the drug
formulation of EV; OR subject has known hypersensitivity to biopharmaceuticals
produced in Chinese hamster ovary (CHO) cells.

- Subject has known hypersensitivity to the following: docetaxel or to any of the other
excipients listed in product label, including polysorbate 80, paclitaxel or to any of
the other excipients listed in product label, such as macrogolglycerol ricinoleate 35
(Ph.Eur.); and vinflunine or to any of the other excipients listed in product label
such as other vinca alkaloids (vinblastine,vincristine, vindesine, vinorelbine).

- Subject has known active keratitis or corneal ulcerations.

- Subject has other underlying medical condition that would impair the ability of the
subject to receive or tolerate the planned treatment and follow-up.

- History of uncontrolled diabetes mellitus within 3 months of the first dose of study
drug. Uncontrolled diabetes is defined as hemoglobin A1C (HbA1c) = 8% or HbA1c between
7 and < 8% with associated diabetes symptoms (polyuria or polydipsia) that are not
otherwise explained.

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site AU61006 - Adelaide
Recruitment hospital [2] 0 0
Site AU61001 - Miranda
Recruitment hospital [3] 0 0
Site AU61004 - St. Leonards
Recruitment hospital [4] 0 0
Site AU61002 - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Miranda
Recruitment postcode(s) [3] 0 0
- St. Leonards
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Rhode Island
Country [14] 0 0
United States of America
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South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Argentina
State/province [18] 0 0
Buenos Aires
Country [19] 0 0
Austria
State/province [19] 0 0
Linz
Country [20] 0 0
Austria
State/province [20] 0 0
Salzburg
Country [21] 0 0
Austria
State/province [21] 0 0
Wien
Country [22] 0 0
Belgium
State/province [22] 0 0
Aalst
Country [23] 0 0
Belgium
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Brussels
Country [24] 0 0
Belgium
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Charleroi
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Belgium
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Gent
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Belgium
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Hasselt
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Belgium
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Leuven
Country [28] 0 0
Belgium
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Liège
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Canada
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Calgary
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Canada
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Edmonton
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Canada
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London
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Canada
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Montreal
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Canada
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Oshawa
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Canada
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Quebec
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Canada
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Saskatoon
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Canada
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Sherbrooke
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Canada
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Toronto
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Vancouver
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Denmark
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Aalborg
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Denmark
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Copenhagen
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Denmark
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Herlev
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France
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Besancon
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Bordeaux
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Brest
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Caen
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Lyon
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Marseille
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Nice
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Paris
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Pierre-Bénite
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France
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Saint-Mande
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Strasbourg
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France
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Toulouse
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France
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Villejuif
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Germany
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Essen
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Germany
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Heidelberg
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Germany
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Munster
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Germany
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Tübingen
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Germany
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Würzburg
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Italy
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Arezzo
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Italy
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Cremona
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Italy
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Milan
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Modena
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Italy
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Pisa
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Italy
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Reggio Emilia
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Italy
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Terni
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Aomori
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Chiba
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Hokkaido
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Ibaraki
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Iwate
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Kagawa
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Kanagawa
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Miyagi
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Osaka
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Tokyo
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Yamaguchi
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Fukuoka
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Hiroshima
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Kyoto
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Niigata
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Okayama
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Tokushima
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Toyama
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Korea, Republic of
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Daejeon
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Goyang-Si
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Korea, Republic of
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Hwasun-gun
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Korea, Republic of
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Shin
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Netherlands
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Amsterdam
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Netherlands
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Nijmegen
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Netherlands
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Tilburg
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Portugal
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Lisboa
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Portugal
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Lisbon
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Portugal
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Porto
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Russian Federation
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Ivanovo
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Russian Federation
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Obninsk
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Russian Federation
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Omsk
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Russian Federation
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Vologda
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Spain
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Badajoz
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Badalona
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Spain
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Barcelona
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Spain
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Córdoba
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Spain
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Madrid
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Spain
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Manresa
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Spain
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Pamplona
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Spain
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Seville
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Spain
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Valencia
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Switzerland
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Bern
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Switzerland
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Chur
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
State/province [117] 0 0
Taoyuan
Country [118] 0 0
United Kingdom
State/province [118] 0 0
London
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United Kingdom
State/province [119] 0 0
Sheffield
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Southampton
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Sutton
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Wirral

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
Seattle Genetics, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the overall survival (OS) of participants with
locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the
OS of participants treated with chemotherapy.

This study will also compare progression-free survival on study therapy (PFS1); the overall
response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in
Solid Tumors (RECIST) V1.1 of participants treated with EV to participants treated with
chemotherapy.

In addition, this study will evaluate the duration of response (DOR) per RECIST V1.1 of EV
and chemotherapy and assess the safety and tolerability of EV, as well as, the quality of
life (QOL) and Patient Reported Outcomes (PRO) parameters.
Trial website
https://clinicaltrials.gov/show/NCT03474107
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Medical Director
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Astellas Pharma Global Development, Inc.
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Contact person for public queries
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Contact person for scientific queries

Summary results
Other publications