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Trial record 1 of 1 for:    NCT03474107
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A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03474107
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : March 13, 2019
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

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.

Condition or disease Intervention/treatment Phase
Ureteral Cancer Urothelial Cancer Bladder Cancer Drug: enfortumab vedotin Drug: docetaxel Drug: vinflunine Drug: paclitaxel Phase 3

Detailed Description:
Participants considered an adult according to local regulation at the time of obtaining informed consent may participate in the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm A: enfortumab vedotin
Participants will receive enfortumab vedotin (EV) on days 1, 8 and 15 of each 28 day cycle.
Drug: enfortumab vedotin
Intravenously (IV)
Other Names:
  • ASG-22ME
  • ASG-22CE

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.
Drug: docetaxel
Intravenously (IV)

Drug: vinflunine
Intravenously (IV)

Drug: paclitaxel
IV infusion

Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 36 months ]
    OS is defined as the time from randomization to the date of death.

Secondary Outcome Measures :
  1. Progression Free Survival on study therapy (PFS1) per Response Evaluation Criteria In Solid Tumors (RECIST) V1.1 [ Time Frame: Up to 24 months ]
    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.

  2. Overall Response Rate (ORR) (Complete Response (CR) and Partial Response(PR)) per RECIST V1.1 [ Time Frame: Up to 24 months ]
    The ORR is defined as the proportion of participants with a complete or partial objective response based on the RECIST V1.1.

  3. Disease Control Rate (DCR) (CR + PR + stable disease [SD]) per RECIST V1.1 [ Time Frame: Up to 24 months ]
    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.

  4. Duration of Response (DOR) per RECIST V1.1 [ Time Frame: Up to 24 months ]
    DOR is defined as the time from the date of the first response CR/PR per RECIST V1.1 (whichever is first recorded) to the date of radiological progression or date of death for participants who achieved CR or PR.

  5. Safety assessed by Adverse Events (AEs) [ Time Frame: Up to 25 months ]

    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.

  6. Number of participants with laboratory value abnormalities and/or adverse events [ Time Frame: Up to 24 months ]
    Number of participants with potentially clinically significant laboratory values.

  7. Number of participants with vital signs abnormalities and/or adverse events [ Time Frame: Up to 25 months ]
    Number of participants with potentially clinically significant vital sign values.

  8. Safety assessed by 12- lead electrocardiogram (ECG) [ Time Frame: Up to 24 months ]

    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.

  9. Safety assessed by Eastern Cooperative Oncology Group Performance Status (ECOG PS) [ Time Frame: Up to 25 months ]
    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.

  10. Patient reported outcome assessed by quality of life: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) [ Time Frame: Up to 25 months ]
    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).

  11. Patient reported outcome assessed by quality of life: EuroQOL 5-dimensions (EQ-5D -5L) questionnaire [ Time Frame: Up to 25 months ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03474107

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Contact: Astellas Pharma Global Development 800-888-7704

  Hide Study Locations
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United States, Alaska
Alaska Clinical Research Center Recruiting
Anchorage, Alaska, United States, 99508
United States, California
The Oncology Institute of Hope Recruiting
Corona, California, United States, 92882
UCI Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
University of California Recruiting
Sacramento, California, United States, 95817
Innovative Clinical Research Recruiting
Whittier, California, United States, 90606
United States, Colorado
University of Colorado Recruiting
Denver, Colorado, United States, 80045
United States, Connecticut
Smilow Cancer Hospital at Yale-New Haven Recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Florida Hospital Recruiting
Orlando, Florida, United States, 32804
United States, Georgia
Piedmont Cancer Institute Recruiting
Atlanta, Georgia, United States, 30318
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40207
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Dana-Farber cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01605
United States, Minnesota
Fairview Ridges Specialty Center Recruiting
Burnsville, Minnesota, United States, 55337
Allina Health System Recruiting
Minneapolis, Minnesota, United States, 55407
United States, Nebraska
Nebraska Cancer Specialists Recruiting
Omaha, Nebraska, United States, 68130
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Queens Medical Associates Recruiting
Fresh Meadows, New York, United States, 11366-1531
Long Island Jewish Medical Center Recruiting
Lake Success, New York, United States, 11042
White Plains Hospital Center for Cancer Care - Oncology Site Recruiting
White Plains, New York, United States, 10601
United States, Ohio
Dayton Physicians LLC Recruiting
Dayton, Ohio, United States, 45430
Toledo Clinic Cancer Center Recruiting
Toledo, Ohio, United States, 43623
United States, Oregon
Providence Portland Med Center Recruiting
Portland, Oregon, United States, 97213
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
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Lifespan Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
United States, South Carolina
Saint Francis Hospital Recruiting
Greenville, South Carolina, United States, 29607
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HOPE Cancer Center of East Texas Recruiting
Tyler, Texas, United States, 75701
United States, Washington
Providence St. Mary Regional Center Recruiting
Lacey, Washington, United States, 98503
Medical Oncology Associates, PS Recruiting
Spokane, Washington, United States, 99208
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Site AU61006 Recruiting
Adelaide, Australia
Site AU61003 Recruiting
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Site AU61001 Recruiting
Miranda, Australia
Site AU61004 Recruiting
St. Leonards, Australia
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Sydney, Australia
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Wien, Austria
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Aalst, Belgium
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Charleroi, Belgium
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Gent, Belgium
Site BE32005 Recruiting
Hasselt, Belgium
Site BE32003 Recruiting
Leuven, Belgium
Site BE32009 Recruiting
Liège, Belgium
Site BE32002 Recruiting
Roeselare, Belgium
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Calgary, Canada
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Edmonton, Canada
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Hamilton, Canada
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London, Canada
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Montreal, Canada
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Saskatoon, Canada
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Sherbrooke, Canada
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Toronto, Canada
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Vancouver, Canada
Site DK45003 Recruiting
Aalborg, Denmark
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Copenhagen, Denmark
Site DN45001 Recruiting
Herlev, Denmark
Site FR33021 Recruiting
Besancon, France
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Bordeaux, France
Site FR33018 Recruiting
Bordeaux, France
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Brest, France
Site FR33016 Recruiting
Caen, France
Site FR33020 Recruiting
Montpellier, France
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Nice, France
Site FR33012 Recruiting
Paris, France
Site FR33005 Recruiting
Pierre-Bénite, France
Site FR33004 Recruiting
Saint-Mande, France
Site FR33002 Recruiting
Strasbourg, France
Site IT39010 Recruiting
Milan, Italy
Site IT39025 Recruiting
Modena, Italy
Site IT39014 Recruiting
Reggio Emilia, Italy
Site IT39006 Recruiting
San Giovanni Rotondo, Italy
Site IT39004 Recruiting
Terni, Italy
Site JP81010 Recruiting
Hirosaki, Aomori, Japan
Site JP81014 Recruiting
Kashiwa, Chiba, Japan
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Sapporo, Hokkaido, Japan
Site JP81020 Recruiting
Tsukuba, Ibaraki, Japan
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Morioka, Iwate, Japan
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Kita-gun, Kagawa, Japan
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Yokohama, Kanagawa, Japan
Site JP81005 Recruiting
Sendai, Miyagi, Japan
Site JP81016 Recruiting
Osakasayama, Osaka, Japan
Site JP81008 Recruiting
Bunkyo-ku, Tokyo, Japan
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Koto-ku, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Ube, Yamaguchi, Japan
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Chiba, Japan
Site JP81019 Recruiting
Fukuoka, Japan
Site JP81004 Recruiting
Hiroshima, Japan
Site JP81001 Recruiting
Kyoto, Japan
Site JP81017 Recruiting
Niigata, Japan
Site JP81003 Recruiting
Okayama, Japan
Site JP81006 Recruiting
Toyama, Japan
Korea, Republic of
Site KR82006 Recruiting
Daejeon, Korea, Republic of
Site KR82007 Recruiting
Goyang-Si, Korea, Republic of
Site KR82002 Recruiting
Incheon, Korea, Republic of
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Seongnam-si, Korea, Republic of
Site KR82003 Recruiting
Seoul, Korea, Republic of
Site KR82004 Recruiting
Seoul, Korea, Republic of
Site KR82008 Recruiting
Seoul, Korea, Republic of
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Shin, Korea, Republic of
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Amsterdam, Netherlands
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Amsterdam, Netherlands
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Lisbon, Portugal
Site ES34014 Recruiting
Córdoba, Spain
Site ES34003 Recruiting
Madrid, Spain
Site ES34013 Recruiting
Madrid, Spain
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Seville, Spain
Site ES34007 Recruiting
Valencia, Spain
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Kaohsiung, Taiwan
Site TW88606 Recruiting
Taichung, Taiwan
Site TW88601 Recruiting
Tainan, Taiwan
Site TW88604 Recruiting
Taipei, Taiwan
United Kingdom
Site UK44005 Recruiting
London, United Kingdom
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Seattle Genetics, Inc.
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Study Director: Senior Medical Director Astellas Pharma Global Development, Inc.

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Responsible Party: Astellas Pharma Global Development, Inc. Identifier: NCT03474107     History of Changes
Other Study ID Numbers: 7465-CL-0301
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
antibody drug conjugate
enfortumab vedotin (EV)
urothelial cancer

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Ureteral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Ureteral Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action