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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02450331
Registration number
NCT02450331
Ethics application status
Date submitted
19/05/2015
Date registered
21/05/2015
Date last updated
18/06/2023
Titles & IDs
Public title
A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection
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Scientific title
A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma After Surgical Resection
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Secondary ID [1]
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2014-005603-25
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Secondary ID [2]
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WO29636
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Universal Trial Number (UTN)
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Trial acronym
IMvigor010
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Transitional Cell
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
0
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Kidney
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Cancer
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0
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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 - Atezolizumab
Experimental: Atezolizumab - Participants will receive intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
No intervention: Observation - Participants will undergo observation starting on Day 1 for 16 cycles (up to 1 year).
Treatment: Drugs: Atezolizumab
Atezolizumab will be administered at a dose of 1200 milligrams (mg).
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Disease-Free Survival (DFS), as Assessed by Investigator
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Assessment method [1]
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DFS is defined as the time from randomization to the time of first occurrence of a DFS event. DFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); urinary tract recurrence of UC (including all pathological stages and grades); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations.
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Timepoint [1]
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Randomization up to first occurrence of DFS event (up to approximately 50 months)
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Overall survival is defined as the time from randomization to the date of death from any cause, regardless of whether the death occurs during study treatment or following treatment discontinuation.
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Timepoint [1]
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Randomization until death due to any cause (up to approximately 80 months)
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Secondary outcome [2]
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Disease-Specific Survival (DSS), as Assessed by Investigator
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Assessment method [2]
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DSS is defined as the time from randomization until the date of death from UC.
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Timepoint [2]
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Randomization until death due to UC (up to approximately 50 months)
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Secondary outcome [3]
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Distant Metastasis-Free Survival (DMFS)
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Assessment method [3]
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DMFS is defined as the time from randomization to the date of diagnosis of distant (that is, non-locoregional) metastases or death from any cause. Tumor assessment will be performed using radiographic evaluations.
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Timepoint [3]
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Randomization up to diagnosis of distant metastases or death from any cause (up to approximately 50 months)
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Secondary outcome [4]
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Non-Urinary Tract Recurrence-Free Survival (NURFS)
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Assessment method [4]
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NURFS is defined as the time from randomization to the time of first occurrence of a NURFS event. NURFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations.
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Timepoint [4]
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Randomization up to time of first occurrence of a NURFS event (up to approximately 50 months)
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Secondary outcome [5]
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Percentage of Participants With Adverse Events (AEs)
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Assessment method [5]
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Percentage of participants with at least one Adverse Event.
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Timepoint [5]
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Screening up to approximately 80 months
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Secondary outcome [6]
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Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
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Assessment method [6]
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Percentage of participants with anti-therapeutic antibodies to atezolizumab.
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Timepoint [6]
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Baseline up to approximately 50 months
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Secondary outcome [7]
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EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score
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Assessment method [7]
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The EQ-5D-5L is a generic preference-based HRQoL questionnaire that provides a single index value for health status and is used to inform pharmacoeconomic evaluations and to measure general health status. Visual analog scale (VAS) allows the patient to indicate, on a scale of 0-100, how his or her health is on the day of assessment, with 100 being the "best imaginable health state" and 0 being the "worst imaginable health state."
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Timepoint [7]
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Day 1 of Cycle 1 up to approximately 50 months (Cycle length = 21 days)
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Secondary outcome [8]
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Minimum Observed Serum Atezolizumab Concentration (Cmin)
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Assessment method [8]
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Minimum observed serum atezolizumab concentration (Cmin) prior to infusion on Day 1 of Cycles 1, 2, 3, and 4; every 8 cycles starting on Cycle 8; at treatment discontinuation; and at 120 days after the last dose of atezolizumab.
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Timepoint [8]
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Pre-dose (Hour 0) on Day 1 of Cycles 1, 2, 3, 4, every 8 cycles from Cycle 8, at treatment discontinuation, 120 days after treatment discontinuation (up to approximately 50 months))(Cycle length = 21 days)
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Secondary outcome [9]
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Maximum Observed Serum Atezolizumab Concentration (Cmax)
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Assessment method [9]
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Maximum observed serum atezolizumab concentration (Cmax) after infusion on Day 1 of Cycle 1.
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Timepoint [9]
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Day 1 of Cycle 1 (Cycle length = 21 days)
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Eligibility
Key inclusion criteria
* Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma) of the bladder or upper urinary tract (i.e., renal pelvis or ureters)
* For participants treated with prior neoadjuvant chemotherapy: tumor stage of ypT2-4a or ypN+ (ypT2-4 or ypN+ for participants with upper urinary tract UC) and M0
* For participants who have not received prior neoadjuvant chemotherapy: tumor stage of pT3-4a or pN+ (pT3-4 or pN+ for participants with upper urinary tract UC) and M0
* Representative formalin-fixed paraffin-embedded tumor specimens from surgical resection (i.e., radical cystectomy, nephroureterectomy, or lymph node dissection) in paraffin blocks (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor programmed death-ligand 1 (PD-L1) expression prior to study enrollment
* Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging scan of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization
* Full recovery from cystectomy or nephroureterectomy within 14 weeks following surgery
* Eastern Cooperative Oncology Group performance status of less than or equal to (</=) 2
* Life expectancy greater than or equal to (>/=) 12 weeks
* Adequate hematologic and end-organ function
* For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use contraceptive methods that result in a failure rate of less than (<) 1 percent (%) per year during the treatment period and for at least 5 months after the last dose of atezolizumab
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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
* Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
* Adjuvant chemotherapy or radiation therapy for UC following surgical resection
* Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives of the drug prior to enrollment
* Malignancies other than UC within 5 years prior to Cycle 1, Day 1
* Pregnancy or breastfeeding
* Significant cardiovascular disease
* Severe infections within 4 weeks prior to Cycle 1, Day 1
* Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1
* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
* Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
* History of autoimmune disease
* Prior allogeneic stem cell or solid organ transplant
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
* Positive test for human immunodeficiency virus and/or active hepatitis B or hepatitis C or tuberculosis
* Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1
* Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-CD40, anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
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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
Stopped early
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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
5/10/2015
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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
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Actual
14/06/2022
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Sample size
Target
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Accrual to date
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Final
809
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Macquarie University Hospital - Macquarie Park
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Recruitment hospital [2]
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Royal Brisbane & Women's Hosp; Cancer Care Serv - Herston
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Recruitment hospital [3]
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Monash Medical Centre; Oncology - Clayton
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Recruitment hospital [4]
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Austin and Repatriation Medical Centre; Cancer Services - Melbourne
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Recruitment postcode(s) [1]
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2109 - Macquarie Park
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3084 - Melbourne
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Recruitment outside Australia
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Baskortostan
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Russian Federation
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Niznij Novgorod
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Russian Federation
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Russian Federation
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Turkey
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Kar??yaka
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Ukraine
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Ukraine
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United Kingdom
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Birmingham
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Southampton
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Funding & Sponsors
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Hoffmann-La Roche
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Summary
Brief summary
This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group.
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Trial website
https://clinicaltrials.gov/study/NCT02450331
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Trial related presentations / publications
Bellmunt J, Hussain M, Gschwend JE, Albers P, Oudard S, Castellano D, Daneshmand S, Nishiyama H, Majchrowicz M, Degaonkar V, Shi Y, Mariathasan S, Grivas P, Drakaki A, O'Donnell PH, Rosenberg JE, Geynisman DM, Petrylak DP, Hoffman-Censits J, Bedke J, Kalebasty AR, Zakharia Y, van der Heijden MS, Sternberg CN, Davarpanah NN, Powles T; IMvigor010 Study Group. Adjuvant atezolizumab versus observation in muscle-invasive urothelial carcinoma (IMvigor010): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):525-537. doi: 10.1016/S1470-2045(21)00004-8. Epub 2021 Mar 12.
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Public notes
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Contacts
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Hoffmann-La Roche
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/31/NCT02450331/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/31/NCT02450331/SAP_001.pdf
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Results are available at
https://clinicaltrials.gov/study/NCT02450331
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