Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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
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)
Query!
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)
Query!
Secondary ID [1]
0
0
MK-3475-676
Query!
Secondary ID [2]
0
0
3475-676
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
High-risk Non-muscle Invasive Bladder Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Bladder - transitional cell cancer
Query!
Renal and Urogenital
0
0
0
0
Query!
Other renal and urogenital disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Complete Response Rate (CRR) by Blinded Independent Central Review (BICR) (Cohort A)
Query!
Assessment method [1]
0
0
CRR is defined as the percentage of participants with CIS achieving a complete response (CR).
Query!
Timepoint [1]
0
0
Up to ~3.5 years
Query!
Primary outcome [2]
0
0
Event-Free Survival (EFS) (Cohort B)
Query!
Assessment method [2]
0
0
EFS is defined as the time from randomization until urothelial carcinoma (UC)-defined event, or death due to any cause.
Query!
Timepoint [2]
0
0
Up to ~5 years
Query!
Secondary outcome [1]
0
0
EFS (Cohort A)
Query!
Assessment method [1]
0
0
EFS is defined as the time from randomization until UC-defined event, or death due to any cause.
Query!
Timepoint [1]
0
0
Up to ~5 years
Query!
Secondary outcome [2]
0
0
Recurrence-Free Survival (RFS) (Cohorts A and B)
Query!
Assessment method [2]
0
0
RFS is defined as the time from randomization until the first occurrence of any UC recurrence, progression, or death due to any cause.
Query!
Timepoint [2]
0
0
Up to ~5 years
Query!
Secondary outcome [3]
0
0
Overall Survival (OS) (Cohorts A and B)
Query!
Assessment method [3]
0
0
OS is defined as the time from randomization to death due to any cause.
Query!
Timepoint [3]
0
0
Up to ~5 years
Query!
Secondary outcome [4]
0
0
Disease Specific Survival (DSS) (Cohorts A and B)
Query!
Assessment method [4]
0
0
DSS is defined as the time from randomization to death due to bladder cancer.
Query!
Timepoint [4]
0
0
Up to ~5 years
Query!
Secondary outcome [5]
0
0
Time to Cystectomy (Cohorts A and B)
Query!
Assessment method [5]
0
0
Time to cystectomy is defined as the time from a participant's randomization until the date of cystectomy.
Query!
Timepoint [5]
0
0
Up to ~5 years
Query!
Secondary outcome [6]
0
0
12-Month EFS Rate (Cohort A)
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
12 months after EFS (up to ~5 years)
Query!
Secondary outcome [7]
0
0
Duration of Response (DOR) (Cohorts A and B)
Query!
Assessment method [7]
0
0
DOR is defined as the time from first documented CR until end of response or death due to any cause, whichever occurs first.
Query!
Timepoint [7]
0
0
Up to ~5 years
Query!
Secondary outcome [8]
0
0
12-Month DOR Rate (Cohorts A and B)
Query!
Assessment method [8]
0
0
The 12-month DOR Rate is defined as the percentage of participants with a CR of at least 12 months duration.
Query!
Timepoint [8]
0
0
12 months after CR (up to ~4.5 years)
Query!
Secondary outcome [9]
0
0
Percentage of Participants Experiencing Adverse Events (AEs) (Cohorts A and B)
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Up to ~5 years
Query!
Secondary outcome [10]
0
0
Percentage of Participants Discontinuing Study Drug Due to AEs (Cohorts A and B)
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Up to ~5 years
Query!
Secondary outcome [11]
0
0
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)
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Baseline, time of last PRO assessment (up to ~2 years)
Query!
Secondary outcome [12]
0
0
Change from Baseline in EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score (Cohorts A and B)
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
Baseline, time of last PRO assessment (up to ~2 years)
Query!
Secondary outcome [13]
0
0
Change from Baseline in EORTC-QLQ-Non-muscle Invasive Bladder Cancer Module 24 (NMIBC24) Total Score (Cohorts A and B)
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
Baseline, time of last PRO assessment (up to ~2 years)
Query!
Secondary outcome [14]
0
0
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)
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
Baseline, time of last PRO assessment (up to ~2 years)
Query!
Secondary outcome [15]
0
0
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)
Query!
Assessment method [15]
0
0
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.
Query!
Timepoint [15]
0
0
Time of last PRO assessment (up to ~2 years)
Query!
Secondary outcome [16]
0
0
TTD in the EQ-5D-5L VAS (Cohorts A and B)
Query!
Assessment method [16]
0
0
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.
Query!
Timepoint [16]
0
0
Time of last PRO assessment (up to ~2 years)
Query!
Secondary outcome [17]
0
0
CRR by BICR (Cohort B)
Query!
Assessment method [17]
0
0
CRR is defined as the percentage of participants with CIS achieving a CR.
Query!
Timepoint [17]
0
0
Up to ~3.5 years
Query!
Secondary outcome [18]
0
0
24-Month EFS Rate (Cohort B)
Query!
Assessment method [18]
0
0
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.
Query!
Timepoint [18]
0
0
24 months after EFS (Up to ~5 years)
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
24/12/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
12/10/2028
Query!
Actual
Query!
Sample size
Target
1405
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
GenesisCare North Shore ( Site 0010) - St Leonards
Query!
Recruitment hospital [2]
0
0
Northern Cancer Institute. ( Site 0003) - St Leonards
Query!
Recruitment hospital [3]
0
0
Sydney Adventist Hospital ( Site 0001) - Wahroonga
Query!
Recruitment hospital [4]
0
0
Epworth Hospital ( Site 0009) - Richmond
Query!
Recruitment postcode(s) [1]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [2]
0
0
2076 - Wahroonga
Query!
Recruitment postcode(s) [3]
0
0
3121 - Richmond
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alaska
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kansas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Louisiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Michigan
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New Jersey
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New York
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Ohio
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Oregon
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Pennsylvania
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
South Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Tennessee
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Texas
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Vermont
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Virginia
Query!
Country [21]
0
0
Austria
Query!
State/province [21]
0
0
Oberosterreich
Query!
Country [22]
0
0
Austria
Query!
State/province [22]
0
0
Tirol
Query!
Country [23]
0
0
Austria
Query!
State/province [23]
0
0
Wien
Query!
Country [24]
0
0
Austria
Query!
State/province [24]
0
0
Salzburg
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Antwerpen
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Namur
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Oost-Vlaanderen
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
Ceara
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Parana
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
Sao Paulo
Query!
Country [31]
0
0
Canada
Query!
State/province [31]
0
0
British Columbia
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
New Brunswick
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
Ontario
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
Quebec
Query!
Country [35]
0
0
China
Query!
State/province [35]
0
0
Beijing
Query!
Country [36]
0
0
China
Query!
State/province [36]
0
0
Chongqing
Query!
Country [37]
0
0
China
Query!
State/province [37]
0
0
Fujian
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Guangdong
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Heilongjiang
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Henan
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Hubei
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Hunan
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Jiangsu
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Shaanxi
Query!
Country [45]
0
0
China
Query!
State/province [45]
0
0
Sichuan
Query!
Country [46]
0
0
China
Query!
State/province [46]
0
0
Tianjin
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Zhejiang
Query!
Country [48]
0
0
Colombia
Query!
State/province [48]
0
0
Antioquia
Query!
Country [49]
0
0
Colombia
Query!
State/province [49]
0
0
Cordoba
Query!
Country [50]
0
0
Colombia
Query!
State/province [50]
0
0
Distrito Capital De Bogota
Query!
Country [51]
0
0
Colombia
Query!
State/province [51]
0
0
Risaralda
Query!
Country [52]
0
0
Colombia
Query!
State/province [52]
0
0
Valle Del Cauca
Query!
Country [53]
0
0
Costa Rica
Query!
State/province [53]
0
0
San Jose
Query!
Country [54]
0
0
Finland
Query!
State/province [54]
0
0
Pirkanmaa
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Bourgogne
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Hauts-de-Seine
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Ille-et-Vilaine
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Nord
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Seine-et-Marne
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Bayern
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Rheinland-Pfalz
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Thuringen
Query!
Country [63]
0
0
Greece
Query!
State/province [63]
0
0
Achaia
Query!
Country [64]
0
0
Greece
Query!
State/province [64]
0
0
Attiki
Query!
Country [65]
0
0
Greece
Query!
State/province [65]
0
0
Kentriki Makedonia
Query!
Country [66]
0
0
Greece
Query!
State/province [66]
0
0
Thessalia
Query!
Country [67]
0
0
Guatemala
Query!
State/province [67]
0
0
Guatemala City
Query!
Country [68]
0
0
Guatemala
Query!
State/province [68]
0
0
Guatemala
Query!
Country [69]
0
0
Hungary
Query!
State/province [69]
0
0
Baranya
Query!
Country [70]
0
0
Hungary
Query!
State/province [70]
0
0
Csongrad
Query!
Country [71]
0
0
Hungary
Query!
State/province [71]
0
0
Budapest
Query!
Country [72]
0
0
Hungary
Query!
State/province [72]
0
0
Debrecen
Query!
Country [73]
0
0
Italy
Query!
State/province [73]
0
0
Abruzzo
Query!
Country [74]
0
0
Italy
Query!
State/province [74]
0
0
Milano
Query!
Country [75]
0
0
Italy
Query!
State/province [75]
0
0
Piemonte
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
Toscana
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Trentino-Sudtirol
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Arezzo
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Bari
Query!
Country [80]
0
0
Italy
Query!
State/province [80]
0
0
Genova
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Palermo
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
Roma
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
Verona
Query!
Country [84]
0
0
Japan
Query!
State/province [84]
0
0
Aomori
Query!
Country [85]
0
0
Japan
Query!
State/province [85]
0
0
Ehime
Query!
Country [86]
0
0
Japan
Query!
State/province [86]
0
0
Ibaraki
Query!
Country [87]
0
0
Japan
Query!
State/province [87]
0
0
Kanagawa
Query!
Country [88]
0
0
Japan
Query!
State/province [88]
0
0
Nara
Query!
Country [89]
0
0
Japan
Query!
State/province [89]
0
0
Shizuoka
Query!
Country [90]
0
0
Japan
Query!
State/province [90]
0
0
Chiba
Query!
Country [91]
0
0
Japan
Query!
State/province [91]
0
0
Fukuoka
Query!
Country [92]
0
0
Japan
Query!
State/province [92]
0
0
Osaka
Query!
Country [93]
0
0
Japan
Query!
State/province [93]
0
0
Tokyo
Query!
Country [94]
0
0
Korea, Republic of
Query!
State/province [94]
0
0
Seoul
Query!
Country [95]
0
0
Malaysia
Query!
State/province [95]
0
0
Kuala Lumpur
Query!
Country [96]
0
0
Netherlands
Query!
State/province [96]
0
0
Limburg
Query!
Country [97]
0
0
Netherlands
Query!
State/province [97]
0
0
Zuid-Holland
Query!
Country [98]
0
0
Netherlands
Query!
State/province [98]
0
0
Utrecht
Query!
Country [99]
0
0
Norway
Query!
State/province [99]
0
0
Akershus
Query!
Country [100]
0
0
Norway
Query!
State/province [100]
0
0
Rogaland
Query!
Country [101]
0
0
Peru
Query!
State/province [101]
0
0
Lima
Query!
Country [102]
0
0
Peru
Query!
State/province [102]
0
0
Muni Metro De Lima
Query!
Country [103]
0
0
Poland
Query!
State/province [103]
0
0
Dolnoslaskie
Query!
Country [104]
0
0
Poland
Query!
State/province [104]
0
0
Kujawsko-pomorskie
Query!
Country [105]
0
0
Poland
Query!
State/province [105]
0
0
Malopolskie
Query!
Country [106]
0
0
Poland
Query!
State/province [106]
0
0
Mazowieckie
Query!
Country [107]
0
0
Poland
Query!
State/province [107]
0
0
Podkarpackie
Query!
Country [108]
0
0
Poland
Query!
State/province [108]
0
0
Pomorskie
Query!
Country [109]
0
0
Poland
Query!
State/province [109]
0
0
Slaskie
Query!
Country [110]
0
0
Poland
Query!
State/province [110]
0
0
Wielkopolskie
Query!
Country [111]
0
0
Portugal
Query!
State/province [111]
0
0
Lisboa
Query!
Country [112]
0
0
Portugal
Query!
State/province [112]
0
0
Braga
Query!
Country [113]
0
0
Portugal
Query!
State/province [113]
0
0
Coimbra
Query!
Country [114]
0
0
Portugal
Query!
State/province [114]
0
0
Porto
Query!
Country [115]
0
0
Puerto Rico
Query!
State/province [115]
0
0
Ponce
Query!
Country [116]
0
0
Spain
Query!
State/province [116]
0
0
La Coruna
Query!
Country [117]
0
0
Spain
Query!
State/province [117]
0
0
Madrid, Comunidad De
Query!
Country [118]
0
0
Spain
Query!
State/province [118]
0
0
Navarra
Query!
Country [119]
0
0
Spain
Query!
State/province [119]
0
0
Barcelona
Query!
Country [120]
0
0
Spain
Query!
State/province [120]
0
0
Madrid
Query!
Country [121]
0
0
Spain
Query!
State/province [121]
0
0
Valencia
Query!
Country [122]
0
0
Switzerland
Query!
State/province [122]
0
0
Basel-Stadt
Query!
Country [123]
0
0
Switzerland
Query!
State/province [123]
0
0
Geneve
Query!
Country [124]
0
0
Switzerland
Query!
State/province [124]
0
0
Zurich
Query!
Country [125]
0
0
Taiwan
Query!
State/province [125]
0
0
Taichung
Query!
Country [126]
0
0
Taiwan
Query!
State/province [126]
0
0
Taipei
Query!
Country [127]
0
0
Turkey
Query!
State/province [127]
0
0
Ankara
Query!
Country [128]
0
0
Turkey
Query!
State/province [128]
0
0
Eskisehir
Query!
Country [129]
0
0
Turkey
Query!
State/province [129]
0
0
Istanbul
Query!
Country [130]
0
0
Turkey
Query!
State/province [130]
0
0
Izmir
Query!
Country [131]
0
0
Turkey
Query!
State/province [131]
0
0
Konya
Query!
Country [132]
0
0
United Kingdom
Query!
State/province [132]
0
0
Highland
Query!
Country [133]
0
0
United Kingdom
Query!
State/province [133]
0
0
London, City Of
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Merck Sharp & Dohme LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Researchers are looking for new ways to treat high-risk non muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment. The goals of this study are to learn: 1. If more people who receive pembrolizumab with Bacillus Calmette-Guerin (BCG) have no signs of cancer in their body and live longer without the cancer growing, spreading, or coming back compared to people who receive BCG alone. 2. About the safety and how well people tolerate BCG alone or in combination with pembrolizumab.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03711032
Query!
Trial related presentations / publications
Kamat AM, Shore N, Hahn N, Alanee S, Nishiyama H, Shariat S, Nam K, Kapadia E, Frenkl T, Steinberg G. KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC. Future Oncol. 2020 Apr;16(10):507-516. doi: 10.2217/fon-2019-0817. Epub 2020 Mar 12.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Director
Query!
Address
0
0
Merck Sharp & Dohme LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Toll Free Number
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-888-577-8839
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
Query!
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/NCT03711032