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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04700124
Registration number
NCT04700124
Ethics application status
Date submitted
5/01/2021
Date registered
7/01/2021
Titles & IDs
Public title
Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)
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Scientific title
A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)
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Secondary ID [1]
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MK-3475-B15
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Secondary ID [2]
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3475-B15
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Universal Trial Number (UTN)
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Trial acronym
KEYNOTE-B15
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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: Other - Pembrolizumab
Treatment: Other - Enfortumab vedotin (EV)
Treatment: Surgery - RC + PLND
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Cisplatin
Experimental: Arm A: Perioperative EV+ Pembrolizumab and RC + PLND - Participants receive 4 cycles (each cycle length = 21 days) of EV intravenous (IV) infusion plus pembrolizumab IV infusion preoperatively, followed by RC + PLND, followed by 5 cycles of adjuvant EV IV infusion plus 13 cycles of adjuvant pembrolizumab IV infusion postoperatively. The total treatment duration is up to approximately 1 year.
Active comparator: Arm B: Standard of Care (SOC)-Neoadjuvant chemotherapy (gemcitabine + cisplatin) and RC + PLND - Participants receive 4 cycles (each cycle length = 21 days) of standard of care (SOC) chemotherapy (gemcitabine IV infusion plus cisplatin IV infusion) preoperatively, followed by RC + PLND. The total treatment duration is up to approximately 3 months.
Treatment: Other: Pembrolizumab
200 mg of Pembrolizumab IV infusion, on Day 1 Q3W for 4 cycles (each cycle length = 21 days) in preoperative phase (up to approximately 3 months) and on Day 1 Q3W for 13 cycles in postoperative phase (up to approximately 9 months). The total duration of treatment is up to approximately 1 year.
Treatment: Other: Enfortumab vedotin (EV)
1.25 mg/kg of EV IV infusion, on Day 1 and Day 8 Q3W for 4 cycles (each cycle length = 21 days) in preoperative phase (up to approximately 3 months) and on Day 1 and Day 8 Q3W for 5 cycles (each cycle length = 21 days) in postoperative phase (up to approximately 4 months). The total duration of treatment is up to approximately 7 months.
Treatment: Surgery: RC + PLND
Curative intent RC + PLND surgery will be administered to all participants randomized to Arm A and B after completion of preoperative systemic treatment (RC + PLND to be done approximately at 15 weeks from randomization).
Treatment: Drugs: Gemcitabine
1000 mg/m\^2 of Gemcitabine IV infusion, Day 1 and Day 8 Q3W for 4 cycles in preoperative phase (up to approximately 3 months)
Treatment: Drugs: Cisplatin
70 mg/m\^2 of Cisplatin IV infusion, Day 1, Q3W for 4 cycles in preoperative phase (up to approximately 3 months)
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Surgery
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Intervention code [3]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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 following events: radiographic disease progression precluding RC + PLND, failure to undergo surgery in participants with residual disease, gross residual disease left behind at time of surgery, local or distant recurrence based on blinded independent central review (BICR) or death due to any cause.
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Timepoint [1]
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Up to ~68 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 defined as the proportion of participants having pCR. pCR is defined as absence of viable tumor (pT0N0) in examined tissue from radical cystectomy (RC) + pelvic lymph node dissection (PLND), as assessed by blinded central pathologic review.
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Timepoint [1]
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Up to ~47 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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OS is defined as the time from randomization to death due to any cause.
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Timepoint [2]
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Up to ~68 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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DFS is defined as the time from postsurgery baseline scan until the first occurrence of either local/distant recurrence as assessed by BICR imaging and/or biopsy or death from any cause.
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Timepoint [3]
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From ~12 months to up to ~68 months
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Secondary outcome [4]
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Pathologic Downstaging (pDS) Rate
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Assessment method [4]
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pDS is defined as participants with \<pT2 (includes pT0, pTis, pTa, and pT1) and N0 in examined tissue from RC plus PLND, based on central pathologic review.
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Timepoint [4]
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Up to ~47 months
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Secondary outcome [5]
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Number of Participants Who Experienced An Adverse Event (AE) (Arm A only)
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Assessment method [5]
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented.
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Timepoint [5]
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Up to ~68 months
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Secondary outcome [6]
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Number of Participants Who Discontinued Study Treatment Due to An AE (Arm A only)
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Assessment method [6]
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be presented.
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Timepoint [6]
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Up to ~68 months
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Secondary outcome [7]
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Number of Participants Experiencing Perioperative Complications
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Assessment method [7]
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Perioperative complications are defined as both intraoperative and postoperative complications, potentially contributing to increased length of inpatient care and/or delay of adjuvant therapy. The number of participants experiencing perioperative complications will be presented.
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Timepoint [7]
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Up to ~68 months
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Secondary outcome [8]
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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
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Assessment method [8]
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The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Participant responses to questions 29 ("How would you rate your overall health during the past week?") and 30 ("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). A higher score indicates a better overall health/quality of life status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined scores will be presented.
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Timepoint [8]
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Baseline, Up to ~68 months
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Secondary outcome [9]
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Change from Baseline in EORTC QLQ-C30 Physical Functioning Scale
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Assessment method [9]
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The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall 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). A higher score indicates a better quality of life. The change from baseline in physical function (EORTC QLQ-C30 Items 1-5) score will be presented.
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Timepoint [9]
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Baseline, Up to ~68 months
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Secondary outcome [10]
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Change From Baseline in Urinary, Bowel and Sexual Domains per Bladder Cancer Index (BCI)
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Assessment method [10]
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The BCI is a 36-item validated, condition-specific health questionnaire to assess the quality of life among participants with bladder cancer. The BCI contains 3 domains: urinary (14 items), bowel (10 items), and sexual (12 items) with function (Likert response scale: 0 \[Never\] - 4 \[Always\]) and bother (Likert response scale: 0 \[No problem\] - 4 \[Big problem\]) subdomains. The domain and subdomain scores are standardized to a 0 to 100 point scale where higher scores correspond better functioning and health-related qualify of life. The change from baseline in the combined scores of the urinary, bowel, and sexual domains of the BCI will be presented.
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Timepoint [10]
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Baseline, Up to ~68 months
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Secondary outcome [11]
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Change from Baseline in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS)
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Assessment method [11]
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The EQ-5D-5L VAS records the respondent's self-rated health on a 10 centimeter (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 [11]
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Baseline, Up to ~68 months
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Secondary outcome [12]
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Change from Baseline in EORTC QLQ-C30 Role Functioning Combined Score (Items 6-7)
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Assessment method [12]
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The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a better level of role functioning. Change from baseline in the role functioning (EORTC QLQ-C30 Items 6-7) combined score will be presented.
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Timepoint [12]
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Baseline, Up to ~68 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.
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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
* Has ongoing sensory or motor neuropathy Grade 2 or higher
* Has active keratitis (superficial punctate keratitis) or corneal ulcerations
* Has a history of uncontrolled diabetes defined as hemoglobin A1c (HbA1c) =8% or HbA1c 7% to <8% with associated diabetes symptoms
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/04/2021
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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
23/12/2026
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Actual
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Sample size
Target
784
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Macquarie University-MQ Health Clinical Trials Unit ( Site 1259) - Macquarie University
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Recruitment hospital [2]
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Mater Hospital Brisbane ( Site 1257) - South Brisbane
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Recruitment hospital [3]
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Lyell McEwin Hospital ( Site 1252) - Elizabeth Vale
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Recruitment hospital [4]
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Frankston Hospital-Oncology and Haematology ( Site 1258) - Frankston
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Recruitment postcode(s) [1]
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2109 - Macquarie University
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [4]
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3199 - Frankston
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Recruitment outside Australia
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Distrito Capital De Bogota
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Grad Zagreb
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Jihomoravsky Kraj
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Csongrad
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Debrecen
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Haifa
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Israel
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Israel
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Zerifin
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Catania
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Milano
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Italy
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Padova
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Aomori
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Japan
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State/province [82]
0
0
Ibaraki
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Country [83]
0
0
Japan
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State/province [83]
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0
Ishikawa
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Country [84]
0
0
Japan
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State/province [84]
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0
Kanagawa
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Country [85]
0
0
Japan
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State/province [85]
0
0
Miyagi
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Country [86]
0
0
Japan
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State/province [86]
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0
Shizuoka
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Country [87]
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0
Japan
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State/province [87]
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0
Gifu
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Country [88]
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0
Japan
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State/province [88]
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0
Nagasaki
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Country [89]
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0
Japan
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State/province [89]
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0
Okayama
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Country [90]
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0
Japan
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State/province [90]
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Osaka
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Country [91]
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0
Japan
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State/province [91]
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0
Tokyo
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Country [92]
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0
Japan
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State/province [92]
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Toyama
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Country [93]
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Korea, Republic of
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State/province [93]
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0
Jeonranamdo
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Country [94]
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0
Korea, Republic of
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State/province [94]
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Kyonggi-do
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Country [95]
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Korea, Republic of
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State/province [95]
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Seoul
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Country [96]
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Korea, Republic of
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State/province [96]
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Taegu-Kwangyokshi
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Country [97]
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Korea, Republic of
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State/province [97]
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Incheon
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Country [98]
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Malaysia
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State/province [98]
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Kuala Lumpur
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Country [99]
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Malaysia
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State/province [99]
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Pulau Pinang
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Malaysia
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State/province [100]
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Sarawak
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Country [101]
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Malaysia
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State/province [101]
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Selangor
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Country [102]
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Philippines
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State/province [102]
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Iloilo
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Country [103]
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0
Poland
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State/province [103]
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0
Dolnoslaskie
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Country [104]
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Poland
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State/province [104]
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Mazowieckie
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Country [105]
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Poland
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State/province [105]
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Podkarpackie
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Country [106]
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Poland
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State/province [106]
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Wielkopolskie
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Country [107]
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Poland
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State/province [107]
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Zachodniopomorskie
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Country [108]
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Portugal
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State/province [108]
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Coimbra
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Country [109]
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Portugal
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State/province [109]
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Lisboa
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Country [110]
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Portugal
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State/province [110]
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Porto
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Country [111]
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Romania
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State/province [111]
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Cluj
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Country [112]
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Romania
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State/province [112]
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0
Dolj
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Country [113]
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Romania
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State/province [113]
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0
Timis
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Country [114]
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0
Romania
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State/province [114]
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0
Bucuresti
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Country [115]
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0
Russian Federation
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State/province [115]
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0
Altayskiy Kray
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Country [116]
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Russian Federation
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State/province [116]
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Kaluzskaja Oblast
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Country [117]
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Russian Federation
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State/province [117]
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Moskva
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Country [118]
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Russian Federation
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State/province [118]
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0
Nizhegorodskaya Oblast
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Country [119]
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Russian Federation
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State/province [119]
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0
Sankt-Peterburg
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Country [120]
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Russian Federation
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State/province [120]
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Sverdlovskaya Oblast
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Country [121]
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Russian Federation
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State/province [121]
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Volgogradskaya Oblast
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Country [122]
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Singapore
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State/province [122]
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Central Singapore
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Country [123]
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South Africa
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State/province [123]
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Gauteng
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Country [124]
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South Africa
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State/province [124]
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Western Cape
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Country [125]
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Spain
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State/province [125]
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Asturias
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Country [126]
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Spain
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State/province [126]
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Barcelona
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Country [127]
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Spain
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State/province [127]
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Gerona
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Country [128]
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Spain
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State/province [128]
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La Coruna
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Country [129]
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Spain
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State/province [129]
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Las Palmas
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Country [130]
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Spain
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State/province [130]
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Valenciana, Comunitat
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Country [131]
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Spain
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State/province [131]
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Madrid
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Country [132]
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Spain
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State/province [132]
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Sevilla
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Country [133]
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Taiwan
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State/province [133]
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Kaohsiung
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Taiwan
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State/province [134]
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Taichung
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Country [135]
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Taiwan
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State/province [135]
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Taipei
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Country [136]
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Ukraine
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State/province [136]
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Dnipropetrovska Oblast
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Country [137]
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Ukraine
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State/province [137]
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Kharkivska Oblast
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Country [138]
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Ukraine
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State/province [138]
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Lvivska Oblast
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Country [139]
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Ukraine
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State/province [139]
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Zhytomyrska Oblast
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Country [140]
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United Kingdom
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State/province [140]
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Devon
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Country [141]
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0
United Kingdom
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State/province [141]
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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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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
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0
Seagen Inc.
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Address [1]
0
0
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Country [1]
0
0
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Other collaborator category [2]
0
0
Commercial sector/industry
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Name [2]
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0
Astellas Pharma Inc
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Address [2]
0
0
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Country [2]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy \[gemcitabine plus cisplatin\] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The primary hypothesis is perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).
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Trial website
https://clinicaltrials.gov/study/NCT04700124
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Medical Director
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Address
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Merck Sharp & Dohme LLC
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0
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Phone
0
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Fax
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Email
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Contact person for public queries
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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)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
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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/NCT04700124