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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
Date last updated
13/06/2025
Titles & IDs
Public title
Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
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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
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Secondary ID [1]
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2019-004542-15
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Secondary ID [2]
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SGN22E-003
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Universal Trial Number (UTN)
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Trial acronym
EV-302
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Urothelial Cancer
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Condition category
Condition code
Intervention/exposure
Study type
Interventional(has expanded access)
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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
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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Blinded Independent Central Review (BICR)
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Assessment method [1]
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PFS was defined as the time from date of randomization to first documentation of disease progression (PD), or to death due to any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). PD could also be unequivocal progression of non-target lesions or the presence of unequivocal new lesions. Kaplan-Meier method was used for analysis.
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Timepoint [1]
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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)
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS was defined as the time from the date of randomization to the date of death from any cause. In the absence of death, OS was censored at the date the participant was last known to be alive. Kaplan-Meier method was used for analysis.
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Timepoint [2]
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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)
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Secondary outcome [1]
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Percentage of Participants With Objective Response Rate (ORR) Per RECIST v1.1 by BICR
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Assessment method [1]
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ORR as per RECIST v1.1 by BICR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) CR was defined as disappearance of all lesions including non-target lesions (not just target lesions). Any pathological lymph nodes must have reduction in short axis to\<10 mm. PR was defined as at least 30 percent \[%\] decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response.
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Timepoint [1]
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From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years)
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Secondary outcome [2]
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Time to Pain Progression (TTPP)
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Assessment method [2]
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TTPP was defined as the time from the date of randomization to date of pain progression. Pain progression was defined as a participant reporting either of the following, whichever came first: 1) Increase of 2 or more points from baseline on Brief Pain Inventory - Short Form (BPI-SF) Question 3 (i.e., pain at its worst in the last 24 hours, score range 0 to 10 with higher scores associated with higher pain levels) maintained for at least two consecutive assessments. 2) Initiation of new opioid medication from baseline for pain with usage maintained for at least two consecutive assessments as recorded in BPI-SF Question 7 (i.e., What medications received for pain).
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Timepoint [2]
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From the date of randomization to date of pain progression (maximum up to approximately 7.4 years)
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Secondary outcome [3]
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Change From Baseline in Worst Pain Using BPI-SF at Week 26
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Assessment method [3]
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Brief Pain Inventory (BPI-SF) was defined as summary of the worst, least, and average pain experienced in the last 24 hours as well as pain right now and number of pain locations were provided for each treatment arm. BPI-sf worst pain measured the severity of pain based on the pain at its worst in the last 24 hours, score range 0 to 10 with higher scores associated with higher pain levels.
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Timepoint [3]
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Baseline, Week 26
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Secondary outcome [4]
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PFS Per RECIST v1.1 by Investigator Assessment
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Assessment method [4]
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PFS as per RECIST v1.1 by investigator was defined as the time from date of randomization to first documentation of PD, or to death due to any cause, whichever comes first. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PD could also be unequivocal progression of non-target lesions or the presence of unequivocal new lesions.
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Timepoint [4]
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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)
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Secondary outcome [5]
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ORR Per RECIST v1.1 by Investigator Assessment
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Assessment method [5]
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ORR as per RECIST v1.1 by investigator was defined as the percentage of participants with confirmed CR or PR. CR was defined as disappearance of all lesions including non-target lesions (not just target lesions). Any pathological lymph nodes must have reduction in short axis to\<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response.
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Timepoint [5]
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From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years)
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Secondary outcome [6]
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Duration of Response (DOR) Per RECIST v1.1 by BICR
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Assessment method [6]
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DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to the first documented PD per RECIST v1.1 per BICR or death from any cause, whichever occurs first. DOR will only include subjects with a confirmed response (CR or PR per RECIST v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to\<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
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Timepoint [6]
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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)
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Secondary outcome [7]
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DOR Per RECIST v1.1 by Investigator Assessment
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Assessment method [7]
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DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to the first documented PD per RECIST v1.1 per investigator or death from any cause, whichever occurs first. DOR will only include subjects with a confirmed response (CR or PR per RECIST v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to\<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response.
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Timepoint [7]
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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)
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Secondary outcome [8]
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Disease Control Rate (DCR) Per RECIST v1.1 by BICR
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Assessment method [8]
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DCR by BICR was defined as the percentage of participants with confirmed response (CR or PR), or SD (or non-CR/non-PD), per RECIST v1.1. Subjects who have no post-baseline response assessments will be considered as non-responders for calculating the DCR. Only response assessments before the first documented PD or subsequent anticancer therapies were considered. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to\<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. SD was defined as a change in tumor size that is neither radiological response (\>30% shrinkage) nor progression (\>20% growth).
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Timepoint [8]
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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)
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Secondary outcome [9]
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DCR Per RECIST v1.1 by Investigator Assessment
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Assessment method [9]
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DCR by BICR was defined as the percentage of participants with confirmed response (CR or PR), or SD (or non-CR/non-PD), per RECIST v1.1. Subjects who have no post-baseline response assessments will be considered as non-responders for calculating the DCR. Only response assessments before the first documented PD or subsequent anticancer therapies were considered. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to\<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. SD was defined as a change in tumor size that is neither radiological response (\>30% shrinkage) nor progression (\>20% growth).
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Timepoint [9]
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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)
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Secondary outcome [10]
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Mean Scores in Patient Reported Outcome (PRO) Assessment Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L)
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Assessment method [10]
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The EQ-5D-5L is a 5-item self-reported measure of functioning and well-being, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (EQ-5D-5L User Guide, 2019). Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems).
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Timepoint [10]
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End of study (approximately up to 7.4 years)
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Secondary outcome [11]
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Change From Baseline in PRO Assessment Measured by the EQ-5D-5L
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Assessment method [11]
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The EQ-5D-5L is a 5-item self-reported measure of functioning and well-being, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (EQ-5D-5L User Guide, 2019). Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems).
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Timepoint [11]
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Baseline, End of study (approximately up to 7.4 years)
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Secondary outcome [12]
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Mean Scores in PRO Assessment Measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
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Assessment method [12]
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EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms.
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Timepoint [12]
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End of study (approximately up to 7.4 years)
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Secondary outcome [13]
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Change From Baseline in PRO Assessment Measured by EORTC QLQ-C30
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Assessment method [13]
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EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.
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Timepoint [13]
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Baseline, End of study (approximately up to 7.4 years)
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Secondary outcome [14]
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Number of Participants With Treatment Emergent Adverse Events Adverse Events (AEs)
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Assessment method [14]
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
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Timepoint [14]
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From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)
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Secondary outcome [15]
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Number of Participants With Serious TEAE
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Assessment method [15]
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SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
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Timepoint [15]
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From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)
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Secondary outcome [16]
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Number of Participants With Grade 3-5 TEAE
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Assessment method [16]
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AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per common terminology criteria for adverse events (CTCAE) version 4, Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE.
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Timepoint [16]
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From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)
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Secondary outcome [17]
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Number of Participants Related to Treatment AEs
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Assessment method [17]
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment relatedness was assessed by the investigator.
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Timepoint [17]
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From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)
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Secondary outcome [18]
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Number of Participants With Laboratory Abnormalities
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Assessment method [18]
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Laboratory abnormalities included Hematology and Serum Chemistry. In Hematology (increased : hemoglobin, lymphocytes, leukocytes, and decreased : hemoglobin, lymphocytes, neutrophils, platelets and leukocytes) and In serum chemistry (increased in : alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium corrected for albumin, creatinine, glucose (non-fasting), potassium, sodium, and decreased in albumin, calcium corrected for albumin, glucose (non-fasting), potassium, phosphate and sodium).
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Timepoint [18]
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From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)
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Secondary outcome [19]
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Number of Participants With Treatment Discontinuation Rate Due to AEs
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Assessment method [19]
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Timepoint [19]
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During study (approximately up to 7.4 years)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/03/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2028
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Actual
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Sample size
Target
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Accrual to date
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Final
886
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Site AU61003 - Box Hill
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Recruitment hospital [2]
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Site AUS61001 - Douglas
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Recruitment hospital [3]
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Site AUS61004 - Heidelberg
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Recruitment hospital [4]
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Site AUS61002 - Macquarie Park
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Recruitment hospital [5]
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Site AUS61006 - South Australia
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Recruitment hospital [6]
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Site AU61005 - South Brisbane
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Recruitment postcode(s) [1]
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3128 - Box Hill
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Recruitment postcode(s) [2]
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4814 - Douglas
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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2109 - Macquarie Park
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Recruitment postcode(s) [5]
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5112 - South Australia
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Recruitment postcode(s) [6]
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4101 - South Brisbane
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Connecticut
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Buenos Aire
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Caba
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La Rioja
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Mendoza
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Rosario
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San Miguel
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Viedma
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Ontario
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Russian Federation
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Tyumen
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Ufa
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Madrid
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Manresa
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HatYai
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Thailand
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Thailand
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Muang
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Thailand
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Antalya
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Turkey
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Edirne
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Istanbul
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Konya
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Turkey
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Malatya
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
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Oxford
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United Kingdom
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Plymouth
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United Kingdom
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Preston
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United Kingdom
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Sheffield
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United Kingdom
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Astellas Pharma Global Development, Inc.
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
0
0
Merck Sharp & Dohme LLC
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Address [1]
0
0
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Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Commercial sector/industry
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Name [2]
0
0
Seagen Inc.
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Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04223856
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
0
0
Zejing Wang, MD, PhD
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Address
0
0
Seagen Inc.
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Seagen Inc. Trial Information Support
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Address
0
0
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Country
0
0
Query!
Phone
0
0
866-333-7436
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/56/NCT04223856/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/56/NCT04223856/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04223856
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