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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04879329
Registration number
NCT04879329
Ethics application status
Date submitted
19/04/2021
Date registered
10/05/2021
Date last updated
2/07/2025
Titles & IDs
Public title
A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2
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Scientific title
A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone or in Combination With Pembrolizumab in Subjects With Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2
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Secondary ID [1]
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C5731002
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Secondary ID [2]
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RC48G001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Urothelial Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Bladder - transitional cell cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - disitamab vedotin
Treatment: Drugs - pembrolizumab
Experimental: Cohort A - DV monotherapy for HER2-positive tumor types - Disitamab vedotin monotherapy
Experimental: Cohort B - DV monotherapy for HER2-low tumor types - Disitamab vedotin monotherapy
Experimental: Cohort C - Non-randomized combination therapy - Disitamab vedotin + pembrolizumab
Experimental: Cohort C - Randomized combination therapy - Disitamab vedotin + pembrolizumab
Experimental: Cohort C - Randomized monotherapy - Disitamab vedotin monotherapy
Experimental: Cohort D - DV monotherapy (Japan only) - Disitamab vedotin monotherapy
Experimental: Cohort E - DV combination therapy (Japan only) - Disitamab vedotin + pembrolizumab
Experimental: Cohort G - DV monotherapy - Disitamab vedotin
Treatment: Drugs: disitamab vedotin
Given into the vein (IV; intravenous) every 2 weeks.
Treatment: Drugs: pembrolizumab
Given by IV on Day 1 of each 6-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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Confirmed Objective Response Rate (cORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) by blinded independent central review (BICR) (Cohorts A, B, C, and G)
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Assessment method [1]
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The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1
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Timepoint [1]
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Duration of treatment; approximately 2 years
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Primary outcome [2]
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Incidence of adverse events (AEs) (Cohorts D and E)
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Assessment method [2]
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Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
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Timepoint [2]
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Approximately 2 years
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Primary outcome [3]
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Incidence of dose alterations (Cohorts D and E)
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Assessment method [3]
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Timepoint [3]
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Approximately 2 years
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Primary outcome [4]
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Incidence of laboratory abnormalities (Cohorts D and E)
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Assessment method [4]
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To be summarized using descriptive statistics.
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Timepoint [4]
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Approximately 2 years
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Primary outcome [5]
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Incidence of electrocardiogram (ECG) abnormalities (Cohorts D and E)
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Assessment method [5]
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Timepoint [5]
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Approximately 2 years
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Primary outcome [6]
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Change from baseline of left ventricular ejection fraction (LVEF) (Cohorts D and E)
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Assessment method [6]
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Timepoint [6]
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Approximately 2 years
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Primary outcome [7]
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Pharmacokinetic (PK) parameter - Area under the curve (AUC) (Cohorts D and E)
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Assessment method [7]
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To be summarized using descriptive statistics.
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Timepoint [7]
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Through 30-37 days following the last dose of DV; up to approximately 2 years
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Primary outcome [8]
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PK parameter - Maximum concentration (Cmax) (Cohorts D and E)
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Assessment method [8]
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To be summarized using descriptive statistics.
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Timepoint [8]
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Through 30-37 days following the last dose of DV; up to approximately 2 years
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Primary outcome [9]
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PK parameter - Time to maximum concentration (Tmax) (Cohorts D and E)
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Assessment method [9]
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To be summarized using descriptive statistics.
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Timepoint [9]
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Through 30-37 days following the last dose of DV; up to approximately 2 years
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Primary outcome [10]
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PK parameter - Trough concentration (Ctrough) (Cohorts D and E)
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Assessment method [10]
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To be summarized using descriptive statistics.
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Timepoint [10]
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Through 30-37 days following the last dose of DV; up to approximately 2 years
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Secondary outcome [1]
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cORR per RECIST v1.1 by investigator assessment (Cohorts A, B, C, and G)
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Assessment method [1]
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The proportion of participants with confirmed CR or PR according to RECIST v1.1
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Timepoint [1]
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Duration of treatment; approximately 2 years
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Secondary outcome [2]
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Confirmed Duration of Response (DOR) per RECIST v1.1 by BICR (Cohorts A, B, C, and G)
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Assessment method [2]
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The time from first documentation of objective tumor response (confirmed CR or PR) to the first documentation of tumor progression per RECIST v1.1 or death due to any cause.
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Timepoint [2]
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From start of treatment to completion of response assessment; approximately 2 years
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Secondary outcome [3]
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Confirmed DOR per RECIST v1.1 by investigator assessment (Cohorts A, B, C, and G)
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Assessment method [3]
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The time from first documentation of objective tumor response (confirmed CR or PR) to the first documentation of tumor progression per RECIST v1.1 or death due to any cause.
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Timepoint [3]
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From start of treatment to completion of response assessment; approximately 2 years
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Secondary outcome [4]
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Progression-free survival (PFS) per RECIST v1.1 by BICR (Cohorts A, B, C, and G)
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Assessment method [4]
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The time from the start of study treatment or randomization (if applicable) to the first documentation of disease progression per RECIST v1.1 or death due to any cause.
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Timepoint [4]
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From start of treatment to completion of response assessment; approximately 2 years
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Secondary outcome [5]
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PFS per RECIST v1.1 by investigator assessment (Cohorts A, B, C, and G)
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Assessment method [5]
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The time from the start of study treatment or randomization (if applicable) to the first documentation of disease progression per RECIST v1.1 or death due to any cause.
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Timepoint [5]
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From start of treatment to completion of response assessment; approximately 2 years
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Secondary outcome [6]
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Disease control rate (DCR) per RECIST v1.1 by BICR (Cohorts A, B, C, and G)
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Assessment method [6]
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The proportion of participants who have achieved objective response (confirmed CR or PR as per RECIST v1.1 criteria) or stable disease (SD) lasting at least 5 weeks.
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Timepoint [6]
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From start of treatment to completion of response assessment; approximately 2 years
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Secondary outcome [7]
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DCR per RECIST v1.1 by investigator (Cohorts A, B, C, and G)
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Assessment method [7]
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The proportion of participants who have achieved objective response (confirmed CR or PR as per RECIST v 1.1 criteria) or SD lasting at least 5 weeks.
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Timepoint [7]
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From start of treatment to completion of response assessment; approximately 2 years
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Secondary outcome [8]
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Overall survival (OS) (Cohorts A, B, C, and G)
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Assessment method [8]
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The time from start of study treatment or randomization (if applicable) to the date of death due to any cause.
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Timepoint [8]
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Duration of study; approximately 3 years
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Secondary outcome [9]
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Incidence of adverse events (AEs) (Cohorts A, B, C, and G)
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Assessment method [9]
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Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
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Timepoint [9]
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Approximately 2 years
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Secondary outcome [10]
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Incidence of dose alterations (Cohorts A, B, C, and G)
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Assessment method [10]
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To be summarized using descriptive statistics.
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Timepoint [10]
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Approximately 2 years
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Secondary outcome [11]
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Incidence of laboratory abnormalities (Cohorts A, B, C, and G)
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Assessment method [11]
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To be summarized using descriptive statistics.
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Timepoint [11]
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Approximately 2 years
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Secondary outcome [12]
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Incidence of ECG abnormalities (Cohorts A, B, C, and G)
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Assessment method [12]
0
0
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Timepoint [12]
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Approximately 2 years
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Secondary outcome [13]
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Change from baseline of LVEF (Cohorts A, B, C, and G)
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Assessment method [13]
0
0
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Timepoint [13]
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Approximately 2 years
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Secondary outcome [14]
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PK parameter - AUC (Cohorts A, B, C, and G)
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Assessment method [14]
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To be summarized using descriptive statistics.
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Timepoint [14]
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Through 30-37 days following the last dose of DV; up to approximately 2 years
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Secondary outcome [15]
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PK parameter - Cmax (Cohorts A, B, C, and G)
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Assessment method [15]
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0
To be summarized using descriptive statistics.
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Timepoint [15]
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Through 30-37 days following the last dose of DV; up to approximately 2 years
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Secondary outcome [16]
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PK parameter - Tmax (Cohorts A, B, C, and G)
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Assessment method [16]
0
0
To be summarized using descriptive statistics.
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Timepoint [16]
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Through 30-37 days following the last dose of DV; up to approximately 2 years
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Secondary outcome [17]
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PK parameter - Ctrough (Cohorts A, B, C, and G)
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Assessment method [17]
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0
To be summarized using descriptive statistics.
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Timepoint [17]
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Through 30-37 days following the last dose of DV; up to approximately 2 years
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Secondary outcome [18]
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PK parameter of pembrolizumab - Cmax (Cohort E)
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Assessment method [18]
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To be summarized using descriptive statistics.
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Timepoint [18]
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Through 30-37 days following the last dose of DV; up to approximately 2 years
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Secondary outcome [19]
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Incidence of anti-drug antibodies (ADAs) against disitamab vedotin (All Cohorts)
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Assessment method [19]
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To be summarized using descriptive statistics.
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Timepoint [19]
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Through 30-37 days following the last dose of DV; up to approximately 2 years
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Secondary outcome [20]
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Incidence of anti-drug antibodies (ADAs) against pembrolizumab (Cohorts C and E)
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Assessment method [20]
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To be summarized using descriptive statistics.
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Timepoint [20]
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Through 30-37 days following the last dose of DV; up to approximately 2 years
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Secondary outcome [21]
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Incidence of neutralizing antibodies (NABs) against disitamab vedotin (All Cohorts)
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Assessment method [21]
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To be summarized using descriptive statistics.
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Timepoint [21]
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Through 30-37 days following the last dose of DV; up to approximately 2 years
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Eligibility
Key inclusion criteria
Cohorts A and B
* Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra
* Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of platinum-containing chemotherapy
* At least one measurable lesion by investigator assessment based on RECIST version 1.1.
* HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Cohort C
* Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra
* No prior systemic therapy for LA/mUC
* Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy
* At least one measurable lesion by investigator assessment based on RECIST v1.1.
* Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation
* HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, on the provided tumor tissue sample
* ECOG performance status of 0, 1, or 2
Cohort D
* Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra
* Based on a participant's eligibility to receive treatment with standard of care therapies in Japan, participants must have received all of the following lines of therapy for LA/mUC:
* a. One prior line of platinum-containing chemotherapy.
* b. Prior therapy with PD-(L)1 inhibitors as (neo)adjuvant therapy, first-line maintenance therapy or as second line treatment.
* c. Prior enfortumab vedotin therapy.
* At least one measurable lesion by investigator assessment based on RECIST v1.1.
* ECOG performance status of 0 or 1
Cohort E
* Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra
* No prior systemic therapy for LA/mUC
* Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy.
* At least one measurable lesion by investigator assessment based on RECIST v1.1.
* Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation
* HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample
* ECOG performance status of 0 or 1
Cohort G
* Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra
* Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of therapy containing enfortumab vedotin as monotherapy or in combination with pembrolizumab
* The last administration of enfortumab vedotin must be 90 days from the start of study treatment. Intervening therapies are allowed between the final dose of enfortumab vedotin and the start of disitamab vedotin.
* At least one measurable lesion by investigator assessment based on RECIST version 1.1.
* HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
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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
Cohorts A and B
* Known hypersensitivity to disitamab vedotin or any of their components
* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohorts A and B)
* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
* Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy
* Major surgery that has not fully recovered within 4 weeks prior to dose administration
* Peripheral sensory or motor neuropathy = Grade 2 at baseline
Cohort C
* Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components
* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study defined as Cycle 1 Day 1 for the single-arm part of Cohort C and as randomization date for the randomized part of Cohort C)
* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
* Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy
* Major surgery that has not fully recovered within 4 weeks prior to dose administration
* Peripheral sensory or motor neuropathy = Grade 2 at baseline
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
* Participants who have previously received any prior treatment with an agent directed to another stimulatory or co-inhibitory T cell receptor (including but not limited to CD137 agonists, CAR-T cell therapy, CTLA-4 inhibitors, or OX-40 agonists) are excluded.
Cohort D
* Known hypersensitivity to disitamab vedotin or any of their components
* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort D)
* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
* Prior HER2-directed therapy
* Any prior history of = Grade 3 non-hematological AEs related to prior therapy
* Major surgery that has not fully recovered within 4 weeks prior to dose administration
* Peripheral sensory or motor neuropathy = Grade 1 at baseline
Cohort E
* Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components
* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort E)
* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
* Any prior history of = Grade 3 non-hematological AEs related to prior therapy
* Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy
* Major surgery that has not fully recovered within 4 weeks prior to dose administration
* Peripheral sensory or motor neuropathy = Grade 1 at baseline
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
Cohort G
* Known hypersensitivity to disitamab vedotin or any of their components
* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort G)
* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
* Prior HER2-directed therapy
* Major surgery that has not fully recovered within 4 weeks prior to dose administration
* Peripheral sensory or motor neuropathy = Grade 2 at baseline
There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
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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
Other
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
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
3/05/2022
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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
14/04/2029
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Actual
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Sample size
Target
372
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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GenesisCare - North Shore - St Leonards
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Recruitment hospital [2]
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Macquarie University - Sydney
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Recruitment hospital [3]
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Mater Cancer Care Centre, Mater Misericordiae Limited - South Brisbane
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Recruitment hospital [4]
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Peninsula & South Eastern Haematology and Oncology Group - Frankston
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Recruitment hospital [5]
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [6]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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2109 - Sydney
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Recruitment postcode(s) [3]
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QLD 4101 - South Brisbane
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Recruitment postcode(s) [4]
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3199 - Frankston
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Recruitment postcode(s) [5]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [6]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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0
United States of America
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Arizona
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California
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United States of America
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District of Columbia
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Florida
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Georgia
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Illinois
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Massachusetts
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United States of America
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Michigan
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New Jersey
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United States of America
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New York
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North Carolina
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Ohio
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Oklahoma
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Wisconsin
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Argentina
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RIO Negro
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Argentina
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Caba
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Argentina
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Ciudad autonoma de Buenos Aires
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Argentina
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Ciudad Autonoma de Buenos Aires
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Argentina
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Cordoba
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Argentina
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Viedma
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Belgium
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Gent
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Belgium
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Namur
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Québec
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Vancouver
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Providencia
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La Serena
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Israel
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Ramat-Gan
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Israel
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Tel Aviv
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Italy
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Lombardy
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Italy
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Terni
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United Kingdom
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London
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Manchester
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Merseyside
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Seagen, a wholly owned subsidiary of Pfizer
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Merck Sharp & Dohme LLC
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Ethics approval
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Summary
Brief summary
This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.
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Trial website
https://clinicaltrials.gov/study/NCT04879329
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Pfizer CT.gov Call Center
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1-800-718-1021
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[email protected]
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Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04879329
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