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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03924856
Registration number
NCT03924856
Ethics application status
Date submitted
22/04/2019
Date registered
23/04/2019
Titles & IDs
Public title
Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866)
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Scientific title
A Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy Versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-866)
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Secondary ID [1]
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MK-3475-866
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Secondary ID [2]
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3475-866
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Universal Trial Number (UTN)
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Trial acronym
KEYNOTE-866
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer
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Condition category
Condition code
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 - Pembrolizumab
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Cisplatin
Treatment: Surgery - Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Treatment: Drugs - Placebo
Experimental: Pembrolizumab + Gemcitabine + Cisplatin + Surgery - Participants received 4 preoperative cycles of pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative pembrolizumab.
Placebo comparator: Placebo + Gemcitabine + Cisplatin + Surgery - Participants received 4 preoperative cycles of placebo to pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative placebo to pembrolizumab.
Treatment: Drugs: Pembrolizumab
Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle
Treatment: Drugs: Gemcitabine
Gemcitabine 1000 mg/m\^2, IV infusion on Days 1 and 8 of each 21-day cycle
Treatment: Drugs: Cisplatin
Cisplatin 70 mg/m\^2, IV infusion on Day 1 of each 21-day cycle
Treatment: Surgery: Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Surgical RC+PLND will be done in accordance with the American Urological Association (AUA)/American Society of Clinical Oncology (ASCO)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO) guidelines.
Treatment: Drugs: Placebo
Placebo to pembrolizumab by IV infusion, given on Day 1 of each 21-day cycle
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Surgery
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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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Event-Free Survival (EFS)
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Assessment method [1]
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EFS is defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC surgery; failure to undergo RC surgery in participants with residual disease and any radiographical disease present; gross residual disease left behind at the time of surgery; local or distant recurrence based on investigator assessments and/or biopsy, or death due to any cause.
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Timepoint [1]
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Up to approximately 60 months
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Secondary outcome [1]
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Pathologic Complete Response (pCR) Rate
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Assessment method [1]
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pCR rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0N0) in examined tissue from RC and PLND, as assessed by blinded independent central review (BICR).
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Timepoint [1]
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Up to approximately 72 months
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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Overall survival is defined as the time from randomization to death due to any cause.
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Timepoint [2]
0
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Up to approximately 72 months
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Secondary outcome [3]
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Disease-Free Survival (DFS)
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Assessment method [3]
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0
DFS is defined as the time from post-surgery baseline scan until the first occurrence of either local or distant recurrence as assessed by investigator by CT or MRI and/or computerized tomography (CT) or magnetic resonance imaging (MRI) and or biopsy or death from any cause.
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Timepoint [3]
0
0
From approximately 20 weeks up to approximately 72 months
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Secondary outcome [4]
0
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Pathologic Downstaging (pDS) Rate
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Assessment method [4]
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pDS rate is defined as the percentage of participants having pDS. pDS is defined as participants with a tumor classification of \<pT2 (includes pT0, pTis, pTa, pT1) and N0 in examined tissue from RC plus PLND as assessed by BICR.
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Timepoint [4]
0
0
Up to approximately 72 months
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Secondary outcome [5]
0
0
Number of Participants Who Experienced an Adverse Event (AE)
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Assessment method [5]
0
0
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
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Timepoint [5]
0
0
Up to approximately 72 months
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Secondary outcome [6]
0
0
Number of Participants Who Discontinued Study Treatment Due to an AE
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Assessment method [6]
0
0
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
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Timepoint [6]
0
0
Up to approximately 12 months
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Secondary outcome [7]
0
0
Number of Participants Who Experienced Perioperative Complications
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Assessment method [7]
0
0
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
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Timepoint [7]
0
0
Up to approximately 12 months
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Secondary outcome [8]
0
0
Change in Patient-Reported Outcomes from Baseline in Total Score of Functional Assessment of Cancer Therapy - General (FACT-G)
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Assessment method [8]
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The FACT-G is a health-related quality of life (HRQoL) 27-item questionnaire in patients being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 to 4, with higher scores indicating higher HRQoL. The total score can range from 0 to 108.
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Timepoint [8]
0
0
Baseline, Up to approximately 72 months
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Secondary outcome [9]
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Change in Patient-Reported Outcomes from Baseline in Total Score of FACT-Bladder- (FACT-BI-Cys)
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Assessment method [9]
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Total Score of FACT BI-Cys is the sum of FACT-G total score and FACT-Bl-Cys score. FACT-Bl-Cys contains 17 items on the bowel, bladder, and sexual symptoms following cystectomy. The FACT-G is a health-related quality of life (HRQoL) 27-item questionnaire in patients being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 to 4, with higher scores indicating higher HRQoL. The total score of FACT-Bl-Cys can range from 0 to 168.
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Timepoint [9]
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Baseline, Up to approximately 72 months
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Secondary outcome [10]
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Change in Patient-Reported Outcomes from Baseline in FACT-BI-Cys-Trial Outcome Index (TOI)
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Assessment method [10]
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FACT-Bl-Cys Trial Outcome Index (TOI) is the sum of FACT-G PWB score, FWB score, and FACT-Bl-Cys score. FACT-Bl-Cys contains 17 items on the bowel, bladder, and sexual symptoms following cystectomy. The FACT-G is a health-related quality of life (HRQoL) 27-item questionnaire in patients being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 to 4, with higher scores indicating higher HRQoL. The total score of FACT-Bl-Cys TOI can range from 0 to 116.
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Timepoint [10]
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0
Baseline, Up to approximately 72 months
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Secondary outcome [11]
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Change in Patient-Reported Outcomes from Baseline in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) Visual Analog Score (VAS)
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Assessment method [11]
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The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. In the EQ-5D-5L VAS, the participant rates his or her general state of health at the time of the assessment on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
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Timepoint [11]
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Baseline, Up to approximately 72 months
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Secondary outcome [12]
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Time to Deterioration (TTD) in the Total Score of FACT-G
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Assessment method [12]
0
0
The FACT-G is a health-related quality of life (HRQoL) 27-item questionnaire in patients being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0-4, with higher scores indicating higher HRQoL. TTD is defined as the time from baseline to the first onset of patient-reported outcomes (PRO) deterioration. For the FACT-G questionnaire, deteriorations are defined as a decrease of 7 points or more (out of 108) from baseline in total score.
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Timepoint [12]
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Up to approximately 72 months
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Secondary outcome [13]
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TTD in EQ-5D-5L VAS
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Assessment method [13]
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The EQ-5D-5L is a standardized instrument for use as a measure of health outcome and includes 5 health state dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In the EQ-5D-5L VAS, the participant rates his or her general state of health at the time of the assessment on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. TTD is defined as the time from baseline to the first onset of PRO deterioration. For the EQ 5D-5L, deterioration is defined as a decrease of 7 points or more from baseline in the VAS.
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Timepoint [13]
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Up to approximately 72 months
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Eligibility
Key inclusion criteria
* Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (=50%) urothelial histology.
* Have clinically non-metastatic bladder cancer (N=1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI)) of the chest/abdomen/pelvis.
* Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND).
* Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Have adequate organ function.
* Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
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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 known additional malignancy that is progressing or has required active anti-cancer treatment =3 years of study randomization with certain exceptions.
* Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).
* Has =N2 disease or metastatic disease (M1) as identified by imaging.
* Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol.
* Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder.
* Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC.
* Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention.
* Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection, Hepatitis B infection or known active Hepatitis C infection.
* Has a known psychiatric or substance abuse disorder.
* Has had an allogenic tissue/solid organ transplant.
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/06/2019
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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
15/06/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
907
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Mid North Coast Cancer Institute ( Site 1256) - Port Macquarie
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Recruitment hospital [2]
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Southside Cancer Care Centre ( Site 1252) - Sydney
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Cairns Base Hospital ( Site 1257) - Cairns
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Eastern Health ( Site 1255) - Box Hill
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Recruitment hospital [5]
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Peninsula Health Frankston Hospital ( Site 1258) - Frankston
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Recruitment postcode(s) [1]
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2444 - Port Macquarie
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Recruitment postcode(s) [2]
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2228 - Sydney
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Recruitment postcode(s) [3]
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4870 - Cairns
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment postcode(s) [5]
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3199 - Frankston
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Recruitment outside Australia
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United States of America
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California
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District of Columbia
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Florida
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Indiana
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Louisiana
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Maine
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Israel
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Israel
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Pavia
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Roma
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Chiba
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Country [78]
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Japan
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Ehime
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Japan
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0
Hokkaido
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Japan
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Ibaraki
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Japan
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Kanagawa
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Japan
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Nara
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Japan
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Saitama
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Japan
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Fukuoka
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Japan
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Hiroshima
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Japan
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Nagano
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Japan
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Osaka
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Japan
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Tokushima
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Japan
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Tokyo
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Seoul
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Mexico
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Nuevo Leon
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Mexico
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Aguascalientes
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Mexico
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Chihuahua
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Mexico
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Tlalpan
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Poland
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Dolnoslaskie
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Poland
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Kujawsko-pomorskie
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Poland
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Mazowieckie
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Poland
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Slaskie
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Russian Federation
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Baskortostan, Respublika
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Russian Federation
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Ivanovskaya Oblast
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Russian Federation
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Krasnoyarskiy Kray
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Russian Federation
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Kurskaya Oblast
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Russian Federation
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Moskva
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Russian Federation
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Murmanskaya Oblast
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Russian Federation
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Nizhegorodskaya Oblast
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Russian Federation
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Omskaya Oblast
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Saratovskaya Oblast
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Spain
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Extremadura
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Spain
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Gerona
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Spain
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Madrid, Comunidad De
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Spain
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Valenciana, Comunitat
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Country [117]
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Sweden
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Jonkopings Lan
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Country [118]
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Sweden
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Uppsala Lan
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Sweden
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Vasterbottens Lan
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Country [120]
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Thailand
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Krung Thep Maha Nakhon
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Country [121]
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Thailand
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Chiang Mai
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Country [122]
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Thailand
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Khon Kaen
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Turkey
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Ankara
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Country [124]
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Turkey
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Istanbul
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Turkey
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Konya
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Country [126]
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Turkey
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Sakarya
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Country [127]
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Turkey
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Trabzon
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Ukraine
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Cherkaska Oblast
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Ukraine
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Dnipropetrovska Oblast
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Ukraine
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Kharkivska Oblast
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Ukraine
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Kyivska Oblast
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Ukraine
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Lvivska Oblast
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Country [133]
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Ukraine
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Kyiv
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Country [134]
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0
United Kingdom
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Aberdeen City
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Country [135]
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0
United Kingdom
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Devon
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Country [136]
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0
United Kingdom
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England
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Country [137]
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United Kingdom
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Hertfordshire
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Country [138]
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United Kingdom
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London, City Of
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Country [139]
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United Kingdom
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Norfolk
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Country [140]
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0
United Kingdom
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Truro
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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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Country
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Ethics approval
Ethics application status
Query!
Summary
Brief summary
A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.
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Trial website
https://clinicaltrials.gov/study/NCT03924856
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Trial related presentations / publications
Galsky MD, Hoimes CJ, Necchi A, Shore N, Witjes JA, Steinberg G, Bedke J, Nishiyama H, Fang X, Kataria R, Sbar E, Jia X, Siefker-Radtke A. Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303. Future Oncol. 2021 Aug;17(24):3137-3150. doi: 10.2217/fon-2021-0273. Epub 2021 May 19.
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Public notes
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Contacts
Principal investigator
Name
0
0
Medical Director
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Address
0
0
Merck Sharp & Dohme LLC
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Country
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0
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Phone
0
0
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Fax
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0
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Email
0
0
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Contact person for public queries
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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/NCT03924856