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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03024996
Registration number
NCT03024996
Ethics application status
Date submitted
17/01/2017
Date registered
19/01/2017
Date last updated
3/08/2023
Titles & IDs
Public title
A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy
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Scientific title
A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy
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Secondary ID [1]
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2016-001881-27
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Secondary ID [2]
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WO39210
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Universal Trial Number (UTN)
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Trial acronym
IMmotion010
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Other interventions - Placebo
Experimental: Atezolizumab - Participants will receive atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).
Placebo comparator: Placebo - Participants will receive placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).
Treatment: Drugs: Atezolizumab
Atezolizumab 1200 mg IV infusion q3w
Other interventions: Placebo
Placebo matching to atezolizumab q3w
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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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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Investigator-assessed Disease-Free Survival (DFS)
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Assessment method [1]
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Investigator-assessed DFS, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS.
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Timepoint [1]
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From baseline up to first occurence of event by investigator assessment (up to approximately 64 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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OS was defined as the time from randomization to death from any cause.
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Timepoint [1]
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From baseline up to death due to any cause (up to approximately 64 months)
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Secondary outcome [2]
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Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3
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Assessment method [2]
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Investigator assessed DFS for participants with PD-L1 expression of IC1/2/3 vs IC0, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS. PD-L1 IC0 was defined as \<1% and IC1/2/3 was defined as \>=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC.
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Timepoint [2]
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From baseline until first occurrence of DFS event (up to approximately 64 months)
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Secondary outcome [3]
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Independent Review Facility (IRF)-Assessed DFS
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Assessment method [3]
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IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first.
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Timepoint [3]
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From baseline until first documented recurrence event (up to approximately 64 months)
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Secondary outcome [4]
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IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3
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Assessment method [4]
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IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first. PD-L1 IC0 was defined as \<1% and IC1/2/3 was defined as \>=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay.
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Timepoint [4]
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From baseline until first occurrence of DFS event (up to approximately 64 months)
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Secondary outcome [5]
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IRF-assessed Event-free Survival (EFS)
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Assessment method [5]
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IRF-assessed EFS was defined as the time from randomization to death from any cause, or the first documented recurrence in participants without baseline disease by IRF or the first documented disease progression in participants identified as having baseline disease by IRF, whichever occurred first. Disease progression was defined as either unequivocal progression of baseline disease or new unequivocal lesions.
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Timepoint [5]
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From baseline until first documented recurrence event (up to approximately 64 months)
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Secondary outcome [6]
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Disease-Specific Survival
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Assessment method [6]
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Disease-specific survival was defined as the time from randomization to death from renal cell carcinoma (RCC).
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Timepoint [6]
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From baseline up to death due to RCC (up to approximately 64 months)
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Secondary outcome [7]
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Distant Metastasis-Free Survival
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Assessment method [7]
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Distant metastasis-free survival, defined as the time from randomization to death from any cause or the date of diagnosis of distant (i.e., non-locoregional) metastases assessed by the investigator, whichever occurred first.
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Timepoint [7]
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From baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 64 months)
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Secondary outcome [8]
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Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3
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Assessment method [8]
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IRF-assessed DFS was defined as the percentage of participants being alive and free of recurrence assessed by IRF at Year 1, 2, and 3 after randomization.
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Timepoint [8]
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Up to 3 years
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Secondary outcome [9]
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Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3
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Assessment method [9]
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Investigator-assessed DFS rate was defined as the percentage of participants being alive and free of recurrence assessed by investigator at Year 1, 2, and 3 after randomization.
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Timepoint [9]
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Up to 3 years
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Secondary outcome [10]
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Percentage of Participants With Adverse Events
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Assessment method [10]
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An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs.
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Timepoint [10]
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From baseline up to death due to any cause (up to approximately 71 months)
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Secondary outcome [11]
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Maximum Serum Concentration (Cmax) of Atezolizumab
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Assessment method [11]
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Timepoint [11]
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Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)
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Secondary outcome [12]
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Minimum Serum Concentration (Cmin) of Atezolizumab
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Assessment method [12]
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Timepoint [12]
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Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)
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Secondary outcome [13]
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Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab
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Assessment method [13]
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Timepoint [13]
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Predose (hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)
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Eligibility
Key inclusion criteria
* ECOG performance status of less than or equal to (</=) 1
* Pathologically confirmed RCC with a component of either clear cell histology or sarcomatoid histology that has not been previously treated in the adjuvant or neoadjuvant setting and classified as being at high risk of RCC recurrence
* Radical or partial nephrectomy with lymphadenectomy in select participants
* Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization. Confirmation of disease-free status will be assessed by an independent central radiologic review of imaging data.
* Absence of brain metastasis, as confirmed by a negative CT with contrast or magnetic resonance imaging (MRI) scan of the brain, no more than 4 weeks prior to randomization. Applicable only to metastasectomy participants
* Full recovery from nephrectomy or metastasectomy within 12 weeks from randomization following surgery
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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
* Bilateral synchronous tumors with inheritable forms of RCC including von Hippel-Lindau
* Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
* Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days or five half-lives of the investigational agent, whichever is longer, prior to enrollment
* Malignancies other than RCC within 5 years prior to Cycle 1, Day 1
* History of autoimmune disease
* Participants with prior allogeneic stem cell or solid organ transplantation
* History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan
* Positive test for HIV
* Participants with active hepatitis B or hepatitis C
* Active tuberculosis
* Severe infections within 4 weeks prior to randomization including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
* Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
* Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
* Prior treatment with cluster of differentiation (CD)137 agonists, anti-cytotoxic T-lymphocyte-associated protein-4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), or anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibody or pathway-targeting agents
* Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to randomization
* Treatment with systemic immunosuppressive medications (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to randomization or anticipated need for systemic immunosuppressive medications during the study
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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 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
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
3/01/2017
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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
8/12/2022
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Sample size
Target
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Accrual to date
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Final
778
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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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Calvary Mater Newcastle; Medical Oncology - Waratah
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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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Ashford Cancer Center Research - Kurralta Park
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Recruitment hospital [4]
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Austin Hospital; Medical Oncology - Heidelberg
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Recruitment postcode(s) [1]
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2298 - Waratah
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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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5037 - Kurralta Park
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment outside Australia
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Arizona
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Ukraine
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United Kingdom
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Leicester
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Funding & Sponsors
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Commercial sector/industry
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Name
Hoffmann-La Roche
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Summary
Brief summary
This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.
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Trial website
https://clinicaltrials.gov/study/NCT03024996
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Trial related presentations / publications
Pal SK, Uzzo R, Karam JA, Master VA, Donskov F, Suarez C, Albiges L, Rini B, Tomita Y, Kann AG, Procopio G, Massari F, Zibelman M, Antonyan I, Huseni M, Basu D, Ci B, Leung W, Khan O, Dubey S, Bex A. Adjuvant atezolizumab versus placebo for patients with renal cell carcinoma at increased risk of recurrence following resection (IMmotion010): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2022 Oct 1;400(10358):1103-1116. doi: 10.1016/S0140-6736(22)01658-0. Epub 2022 Sep 10. Marconi L, Sun M, Beisland C, Klatte T, Ljungberg B, Stewart GD, Dabestani S, Choueiri TK, Bex A. Prevalence, Disease-free, and Overall Survival of Contemporary Patients With Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials. Clin Genitourin Cancer. 2021 Apr;19(2):e92-e99. doi: 10.1016/j.clgc.2020.12.005. Epub 2021 Jan 7.
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Public notes
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Contacts
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Clinical Trials
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Hoffmann-La Roche
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/96/NCT03024996/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/96/NCT03024996/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03024996
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