A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy
Universitätsklinikum Jena, Urologische Klinik und Poliklinik 07743 Jena (Thüringen) GermanyRekrutierend» Google-MapsKlinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik 81675 München (Bayern) GermanyRekrutierend» Google-MapsUniversitätsklinikum Münster, Klinik für Urologie und Kinderurologie 48149 Münster (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsUniversitätsklinikum Tübingen; Klinik für Urologie 72076 Tübingen (Baden-Württemberg) GermanyRekrutierend» Google-MapsUniversitätsklinikum Ulm; Klinik für Urologie 89081 Ulm (Baden-Württemberg) GermanyRekrutierend» Google-MapsUniversitätsklinikum Würzburg; Klinik und Poliklinik für Urologie und Kinderurologie 97080 Würzburg (Bayern) GermanyRekrutierend» Google-MapsSansum Clinic 93105 Santa Barbara United StatesZurückgezogen» Google-MapsRocky Mountain Cancer Center - Denver 80120 Littleton United StatesRekrutierend» Google-MapsWoodlands Medical Specialists, P.A. 32503 Pensacola United StatesZurückgezogen» Google-MapsCancer Care Centers of Brevard 32955 Rockledge United StatesZurückgezogen» Google-MapsOptum Health Care 89102 Las Vegas United StatesRekrutierend» Google-MapsWake Forest Baptist Medical Center 27157 Winston-Salem United StatesRekrutierend» Google-MapsCleveland Clinic 44195 Cleveland United StatesRekrutierend» Google-MapsAllegheny General Hospital 15212 Pittsburgh United StatesRekrutierend» Google-MapsTexas Oncology Cancer Center 78731 Austin United StatesZurückgezogen» Google-MapsTexas Oncology-Medical City Dallas 75230 Dallas United StatesZurückgezogen» Google-MapsTexas Oncology-Denton South 76201 Denton United StatesZurückgezogen» Google-MapsTexas Oncology-Fort Worth 12th Ave 76104 Fort Worth United StatesZurückgezogen» Google-MapsTexas Oncology - Houston (Gessner) 77024 Houston United StatesZurückgezogen» Google-MapsTexas Oncology - Willowbrook 77070 Houston United StatesZurückgezogen» Google-MapsTexas Oncology P.A. 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1. Investigator-assessed DFS (Time Frame - Randomization up to first occurrence of DFS event (up to approximately 40 months)): Investigator-assessed disease-free survival (DFS), defined as the time from randomization to the first occurrence of a DFS event, defined as any of the following:
Local (pelvic) recurrence of urothelial carcinoma (UC) (including soft tissue and regional lymph nodes)
Urinary tract recurrence of UC (including all pathological stages and grades)
Distant metastasis of UC
Death from any cause
Secondary outcome:
1. Overall survival (OS) (Time Frame - Randomization up to death from any cause (up to approximately 10 years)): Overall survival (OS), defined as the time from randomization to death from any cause.
2. Independent Review Facility (IRF)-Assessed DFS (Time Frame - Randomization up to first occurrence of DFS event (up to approximately 40 months))
3. Investigator-Assessed Disease-Specific Survival (Time Frame - Randomization to death from UC (up to approximately 10 years)): Investigator-assessed disease-specific survival, defined as the time from randomization to death from UC per investigator assessment of cause of death.
4. Investigator-Assessed Distant Metastasis-Free Survival (Time Frame - Randomization to diagnosis of distant metastases or death from any cause (up to approximately 10 years)): Investigator-assessed distant metastasis-free survival, defined as the time from randomization to the diagnosis of distant (i.e., non-locoregional) metastases or death from any cause.
5. Time to Confirmed Deterioration of Function and Health Related Quality of Life (HRQoL) (Time Frame - Randomization to participant's first score decrease of >=10 points from Baseline on EORTC QLQ-C30 physical function scale, role function scale, and the GHS/QoL Scale (up to approximately 10 years)): Time to confirmed deterioration of function and health-related quality of life (HRQoL), defined as the time from randomization to the date of a participant's first score decrease of >= 10 points from baseline on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) physical function scale, role function scale, and the global health status (GHS)/QoL scale (separately), held for at least two consecutive time points or followed by death.
6. ctDNA Clearance (Time Frame - Baseline, Cycle 3 Day 1 or Cycle 5 Day 1 (each cycle is 28 days)): ctDNA clearance, defined as the proportion of patients who are ctDNA positive at baseline and ctDNA negative at Cycle 3, Day 1 or Cycle 5, Day 1.
7. Percentage of Participants With Adverse Events (Time Frame - Baseline up to approximately 10 years)
8. Serum Concentration of Atezolizumab (Time Frame - At pre-defined intervals from first administration of study drug up to approximately 10 years)
9. Incidence of Anti-Drug Antibodies (ADAs) to Atezolizumab (Time Frame - Baseline up to approximately 10 years): Incidence of anti-drug antibodies (ADAs) to atezolizumab after initiation of study treatment (postbaseline incidence).
10. Prevalence of ADAs to Atezolizumab (Time Frame - Baseline): Prevalence of ADAs to atezolizumab at baseline.
Experimental: Arm A: Atezolizumab Atezolizumab will be administered intravenously at a dose of 1680 milligrams (mg) on Day 1 of each 28-day cycle for 12 cycles or up to 1 year (whichever occurs first). Atezolizumab will be discontinued in the event of IRF-assessed disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor.
Placebo Comparator: Arm B: Placebo Placebo will be administered intravenously on Day 1 of each 28-day cycle. Placebo will be discontinued in the event of IRF-assessed disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor.
Atezolizumab (Tecentriq): Participants will receive 1680 mg intravenously every 4 weeks (Q4W) on Day 1 of each 28-day cycle.
Placebo: Participants will receive placebo intravenously Q4W on Day 1 of each 28-day cycle
Quelle: ClinicalTrials.gov
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"A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy"
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