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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03711032
Registration number
NCT03711032
Ethics application status
Date submitted
15/10/2018
Date registered
18/10/2018
Date last updated
11/06/2024
Titles & IDs
Public title
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
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Scientific title
A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Either Persistent or Recurrent Following BCG Induction or That is Naïve to BCG Treatment (KEYNOTE-676)
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Secondary ID [1]
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MK-3475-676
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Secondary ID [2]
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3475-676
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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:
High-risk Non-muscle Invasive Bladder Cancer
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Condition category
Condition code
Cancer
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Bladder - transitional cell cancer
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Renal and Urogenital
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab
Treatment: Other - BCG
Experimental: BCG plus Pembrolizumab: Post-induction Cohort A (Arm A-1) - Participants receive BCG (Induction and Maintenance) in combination with 200 mg pembrolizumab administered intravenously (IV) every 3 weeks (Q3W) for 35 doses (\~2 years).
Experimental: BCG Monotherapy: Post-induction Cohort A (Arm A-2) - Participants receive BCG monotherapy (Induction and Maintenance).
Experimental: BCG plus Pembrolizumab: BCG Naïve Cohort B-Reduced Maintenance (Arm B-1) - Participants receive BCG (Induction and reduced Maintenance) in combination with 400 mg pembrolizumab administered IV every 6 weeks (Q6W) for 9 doses (\~1 year).
Experimental: BCG plus Pembrolizumab: BCG Naïve Cohort B-Full Maintenance (Arm B-2) - Participants receive BCG (Induction and full Maintenance) in combination with 400 mg pembrolizumab administered IV Q6W for 9 doses (\~1 year).
Experimental: BCG Monotherapy: BCG Naïve Cohort B (Arm B-3) - Participants receive BCG monotherapy (Induction and Maintenance).
Treatment: Other: Pembrolizumab
Pembrolizumab IV infusion of 200 mg Q3W for BCG Post-Induction Cohort (Cohort A), or IV infusion of 400 mg Q6W for BCG Naïve Cohort (Cohort B), according to randomization
Treatment: Other: BCG
BCG (intravesical instillation): powder for instillation fluid for intravesical use, administered during Induction and Maintenance therapy
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Intervention code [1]
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Treatment: Other
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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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Complete Response Rate (CRR) by Blinded Independent Central Review (BICR) (Cohort A)
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Assessment method [1]
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CRR is defined as the percentage of participants with CIS achieving a complete response (CR).
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Timepoint [1]
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Up to ~3.5 years
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Primary outcome [2]
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Event-Free Survival (EFS) (Cohort B)
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Assessment method [2]
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EFS is defined as the time from randomization until urothelial carcinoma (UC)-defined event, or death due to any cause.
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Timepoint [2]
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Up to ~5 years
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Secondary outcome [1]
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EFS (Cohort A)
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Assessment method [1]
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EFS is defined as the time from randomization until UC-defined event, or death due to any cause.
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Timepoint [1]
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Up to ~5 years
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Secondary outcome [2]
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Recurrence-Free Survival (RFS) (Cohorts A and B)
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Assessment method [2]
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RFS is defined as the time from randomization until the first occurrence of any UC recurrence, progression, or death due to any cause.
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Timepoint [2]
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Up to ~5 years
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Secondary outcome [3]
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Overall Survival (OS) (Cohorts A and B)
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Assessment method [3]
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OS is defined as the time from randomization to death due to any cause.
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Timepoint [3]
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Up to ~5 years
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Secondary outcome [4]
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Disease Specific Survival (DSS) (Cohorts A and B)
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Assessment method [4]
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DSS is defined as the time from randomization to death due to bladder cancer.
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Timepoint [4]
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Up to ~5 years
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Secondary outcome [5]
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Time to Cystectomy (Cohorts A and B)
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Assessment method [5]
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Time to cystectomy is defined as the time from a participant's randomization until the date of cystectomy.
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Timepoint [5]
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Up to ~5 years
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Secondary outcome [6]
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12-Month EFS Rate (Cohort A)
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Assessment method [6]
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EFS is defined as the time from randomization until UC-defined event, or death due to any cause. The 12-month EFS rate is defined as the percentage of participants with EFS at 12 months.
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Timepoint [6]
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12 months after EFS (up to ~5 years)
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Secondary outcome [7]
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Duration of Response (DOR) (Cohorts A and B)
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Assessment method [7]
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DOR is defined as the time from first documented CR until end of response or death due to any cause, whichever occurs first.
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Timepoint [7]
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Up to ~5 years
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Secondary outcome [8]
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12-Month DOR Rate (Cohorts A and B)
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Assessment method [8]
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The 12-month DOR Rate is defined as the percentage of participants with a CR of at least 12 months duration.
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Timepoint [8]
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12 months after CR (up to ~4.5 years)
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Secondary outcome [9]
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Percentage of Participants Experiencing Adverse Events (AEs) (Cohorts A and B)
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Assessment method [9]
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An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
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Timepoint [9]
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Up to ~5 years
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Secondary outcome [10]
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Percentage of Participants Discontinuing Study Drug Due to AEs (Cohorts A and B)
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Assessment method [10]
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An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
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Timepoint [10]
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Up to ~5 years
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Secondary outcome [11]
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Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score (Cohorts A and B)
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Assessment method [11]
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The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. The change from baseline in Global Health Status/Quality of Life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented.
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Timepoint [11]
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Baseline, time of last PRO assessment (up to ~2 years)
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Secondary outcome [12]
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Change from Baseline in EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score (Cohorts A and B)
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Assessment method [12]
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EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.
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Timepoint [12]
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Baseline, time of last PRO assessment (up to ~2 years)
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Secondary outcome [13]
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Change from Baseline in EORTC-QLQ-Non-muscle Invasive Bladder Cancer Module 24 (NMIBC24) Total Score (Cohorts A and B)
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Assessment method [13]
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The EORTC-QLQ-NMIBC24 is a 24-item questionnaire developed to supplement the EORTC QLQ-C30 in high-risk NMIBC patients. Each item is scored out of 4 total points (1=Not at All to 4=Very Much). All responses are transformed from 0 to 100, with a high score indicating more symptoms or problems. The change from baseline in EORTC-QLQ-NMIBC24 total score will be presented.
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Timepoint [13]
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Baseline, time of last PRO assessment (up to ~2 years)
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Secondary outcome [14]
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Change from Baseline in European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS) (Cohorts A and B)
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Assessment method [14]
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The EQ-5D-5L VAS records the respondent's self-rated health on a 10 cm vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". The change from baseline in EQ-5D-5L VAS will be presented.
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Timepoint [14]
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Baseline, time of last PRO assessment (up to ~2 years)
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Secondary outcome [15]
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Time to Deterioration (TTD) in the EORTC-QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score (Cohorts A and B)
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Assessment method [15]
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EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. TTD in Global Health Status/Quality of Life is defined as the time from baseline to the first onset of a 10 point or greater decrease from baseline in the Global Health Status/Quality of Life (EORTC QLQ-C30 Items 29 and 30) combined score, with or without subsequent confirmation.
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Timepoint [15]
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Time of last PRO assessment (up to ~2 years)
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Secondary outcome [16]
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TTD in the EQ-5D-5L VAS (Cohorts A and B)
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Assessment method [16]
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The EQ-5D-5L VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". TTD in EQ-5D-5L VAS is defined as the time from baseline to the first onset of a 7 point or greater decrease from baseline in EQ-5D-5L VAS, with or without subsequent confirmation, under a right-censoring rule.
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Timepoint [16]
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Time of last PRO assessment (up to ~2 years)
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Secondary outcome [17]
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CRR by BICR (Cohort B)
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Assessment method [17]
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CRR is defined as the percentage of participants with CIS achieving a CR.
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Timepoint [17]
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Up to ~3.5 years
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Secondary outcome [18]
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24-Month EFS Rate (Cohort B)
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Assessment method [18]
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EFS is defined as the time from randomization until UC-defined event, or death due to any cause. The 24-month EFS rate is defined as the percentage of participants with EFS at 24 months.
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Timepoint [18]
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24 months after EFS (Up to ~5 years)
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Eligibility
Key inclusion criteria
* Have locally and blinded independent central review (BICR)-confirmed histological diagnosis of high-risk non-muscle invasive (T1, high grade Ta and/or CIS) UC of the bladder
* Has undergone cystoscopy/ transurethral resection of bladder tumor (TURBT) to remove all resectable disease
* Has provided tissue for biomarker analysis
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Has adequate organ function
* During the treatment period and for =7 days after the last dose of BCG, male participants are EITHER abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR, must agree to use contraception unless confirmed to be azoospermic
* Female participants who are not pregnant, not breastfeeding, and either not a woman of child bearing potential (WOCBP); or are a WOCBP who agrees to use a contraception method that is highly effective or remains abstinent from heterosexual intercourse during the treatment period and for =7 days after the last dose of BCG or 120 days after the last dose of pembrolizumab, whichever comes last
BCG Post-induction Cohort (Cohort A) Only
* Has been treated with one adequate course of BCG induction therapy for the treatment of HR NMIBC
* Following adequate BCG induction therapy, must have persistent or recurrent HR NMIBC
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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
* Has a history of or concurrent locally advanced (i.e., T2, T3, T4) or metastatic UC
* Has concurrent extra-vesical (i.e, urethra, ureter, renal pelvis) non-muscle invasive urothelial carcinoma or a history of extra-vesical non-muscle invasive UC
* Has received prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks of start of study treatment
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks of start of study treatment
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days of start of study treatment
* Has a known additional malignancy that is progressing or requires active treatment within the past 3 years
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has one or more of the following contraindications to BCG: prior BCG sepsis or systemic infection, total bladder incontinence, or an adverse experience to a previous BCG instillation that resulted in treatment discontinuation and precludes retreating with BCG
* Has an active infection or diagnosis requiring systemic antimicrobial therapy
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of Hepatitis B or known active Hepatitis C virus infection
* Has current active tuberculosis
* Has had an allogenic-tissue/solid organ transplant
* Has any contraindication(s) to IV contrast or is otherwise unable to have screening imaging with IV contrast performed
BCG Post-induction Cohort (Cohort A) Only - Has persistent T1 disease following an induction course of BCG
BCG Naïve Cohort (Cohort B) Only
- Has received any prior treatment with BCG for their NMIBC within the past 2 years prior to study entry
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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
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
24/12/2018
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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
12/10/2028
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Actual
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Sample size
Target
1405
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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GenesisCare North Shore ( Site 0010) - St Leonards
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Recruitment hospital [2]
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Northern Cancer Institute. ( Site 0003) - St Leonards
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Recruitment hospital [3]
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Sydney Adventist Hospital ( Site 0001) - Wahroonga
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Recruitment hospital [4]
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Epworth Hospital ( Site 0009) - Richmond
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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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2076 - Wahroonga
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Recruitment postcode(s) [3]
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3121 - Richmond
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Recruitment outside Australia
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United States of America
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Alaska
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Colorado
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0
Germany
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Rheinland-Pfalz
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Germany
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Thuringen
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Greece
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Achaia
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Country [64]
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Greece
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Attiki
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Greece
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Kentriki Makedonia
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Greece
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Thessalia
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Guatemala
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Guatemala City
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Guatemala
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Guatemala
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Hungary
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Baranya
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Hungary
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Csongrad
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Hungary
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Budapest
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Hungary
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Debrecen
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Italy
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Abruzzo
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Italy
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Milano
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Italy
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Piemonte
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Italy
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Toscana
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Italy
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Trentino-Sudtirol
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Italy
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Arezzo
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Country [79]
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Italy
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Bari
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Country [80]
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Italy
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Genova
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Country [81]
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Italy
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Palermo
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Italy
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Roma
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Italy
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Verona
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Japan
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Aomori
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Japan
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Ehime
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Japan
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Ibaraki
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Country [87]
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Japan
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Kanagawa
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Country [88]
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Japan
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Nara
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Country [89]
0
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Japan
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Shizuoka
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Country [90]
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0
Japan
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Chiba
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Country [91]
0
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Japan
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State/province [91]
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Fukuoka
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Country [92]
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Japan
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State/province [92]
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Osaka
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Country [93]
0
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Japan
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Tokyo
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Korea, Republic of
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Seoul
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Country [95]
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Malaysia
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State/province [95]
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Kuala Lumpur
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Country [96]
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Netherlands
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State/province [96]
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Limburg
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Netherlands
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Zuid-Holland
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Netherlands
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Utrecht
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Country [99]
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Norway
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Akershus
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Norway
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Rogaland
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Country [101]
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Peru
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State/province [101]
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Lima
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Country [102]
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Peru
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State/province [102]
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Muni Metro De Lima
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Country [103]
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Poland
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State/province [103]
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Dolnoslaskie
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Country [104]
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Poland
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State/province [104]
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Kujawsko-pomorskie
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Country [105]
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Poland
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State/province [105]
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Malopolskie
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Poland
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State/province [106]
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Mazowieckie
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Poland
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State/province [107]
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Podkarpackie
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Country [108]
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Poland
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State/province [108]
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Pomorskie
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Country [109]
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Poland
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State/province [109]
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Slaskie
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Country [110]
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Poland
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State/province [110]
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Wielkopolskie
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Country [111]
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Portugal
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State/province [111]
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Braga
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Country [112]
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Portugal
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Coimbra
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Country [113]
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Portugal
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Lisboa
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Country [114]
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Portugal
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Porto
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Country [115]
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Puerto Rico
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State/province [115]
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Ponce
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Country [116]
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Spain
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State/province [116]
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La Coruna
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Country [117]
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Spain
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State/province [117]
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Madrid, Comunidad De
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Country [118]
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Spain
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Navarra
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Country [119]
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Spain
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Barcelona
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Country [120]
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Spain
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Madrid
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Country [121]
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Spain
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Valencia
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Country [122]
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Switzerland
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Basel-Stadt
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Country [123]
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Switzerland
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Geneve
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Country [124]
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Switzerland
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Zurich
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Taiwan
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Taichung
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Country [126]
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Taiwan
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Taipei
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Country [127]
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Turkey
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Ankara
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Country [128]
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Turkey
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Eskisehir
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Country [129]
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Turkey
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Istanbul
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Country [130]
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Turkey
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Izmir
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Country [131]
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Turkey
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Konya
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Country [132]
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United Kingdom
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Highland
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Country [133]
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0
United Kingdom
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0
London, City Of
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG.
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Trial website
https://clinicaltrials.gov/study/NCT03711032
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Public notes
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Contacts
Principal investigator
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0
Medical Director
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Address
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0
Merck Sharp & Dohme LLC
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0
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Contact person for public queries
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Toll Free Number
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0
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Phone
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0
1-888-577-8839
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0
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Email
0
0
[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT03711032
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