Um estudo de atezolizumabe versus placebo como terapia adjuvante em pacientes com câncer de bexiga músculo-invasivo de alto risco que são positivos para ctDNA após cistectomia (IMvigor011)
Um estudo de Fase III, duplo-cego, multicêntrico, randomizado de atezolizumabe (anticorpo anti-PDL1) versus placebo como terapia adjuvante em pacientes com câncer de bexiga invasivo de músculo de alto risco que são positivos para ctDNA após cistectomia
This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are circulating tumour deoxyribonucleic acid (ctDNA) positive and are at high risk for recurrence following cystectomy.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
-
-
-
Düsseldorf, Alemanha, 40225
- Universitätsklinikum Düsseldorf
-
Halle, Alemanha, 06120
- Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
-
Herne, Alemanha, 44625
- Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik
-
Tübingen, Alemanha, 72076
- Universitätsklinikum Tübingen
-
Ulm, Alemanha, 89081
- Universitätsklinikum Ulm
-
Würzburg, Alemanha, 97080
- Universitätsklinikum Würzburg
-
-
-
-
-
Buenos Aires, Argentina, 1019
- Centro Medico Austral
-
Buenos Aires, Argentina, 1426
- Instituto Alexander Fleming
-
-
-
-
Ceará
-
Fortaleza, Ceará, Brasil, 60170-170
- Oncocentro Serviços Medicos E Hospitalares Ltda
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brasil, 30110022
- CETUS Hospital Dia Oncologia
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasil, 91350-200
- Hospital Nossa Senhora da Conceicao
-
Porto Alegre, Rio Grande do Sul, Brasil, 90610-000
- Hospital Sao Lucas - PUCRS
-
-
São Paulo
-
Barretos, São Paulo, Brasil, 14784-400
- *X*Fundação Pio XII Hospital de Câncer de Barretos
-
Jaú, São Paulo, Brasil, 17210-120
- Hospital Amaral Carvalho
-
São Paulo, São Paulo, Brasil, 01323-020
- Hospital Alemao Oswaldo Cruz
-
São Paulo, São Paulo, Brasil, 01246-000
- Instituto do Cancer do Estado de Sao Paulo - ICESP
-
-
-
-
-
Brasschaat, Bélgica, 2930
- AZ KLINA
-
Ghent, Bélgica, 9000
- UZ Gent
-
-
-
-
-
Beijing, China, 100050
- Friendship Hospital, Capital Medical University
-
Changchun, China, 130021
- the First Hospital of Jilin University
-
Changsha, China, 410006
- Hu Nan Provincial Cancer Hospital
-
Fuzhou, China, 350005
- The First Affiliated Hospital of Fujian Medical University
-
Guangzhou, China, 510120
- The First Affiliated Hospital of Guangzhou Medical University
-
Nanjing, China, 210009
- Jiangsu Cancer Hospital
-
Nanjing, China, 210029
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
-
Nanjing, China, 210029
- Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
-
Shanghai, China, 200032
- Zhongshan Hospital Fudan University
-
Shanghai, China, 200120
- Fudan University Shanghai Cancer Center
-
Tianjin, China, 300060
- Tianjin Cancer Hospital
-
Yantai, China, 264099
- Yantai Yu Huangding Hospital
-
-
-
-
-
Singapore, Cingapura, 168583
- National Cancer Centre
-
-
-
-
-
Bogotá, Colômbia, 11001
- Clinica del Country
-
Medellín, Colômbia, 050024
- Instituto Cancerología Medellin
-
Montería, Colômbia, 230002
- Oncomedica S.A.
-
-
-
-
-
Goyang-si, Coréia do Sul, 10408
- National Cancer Center
-
Seoul, Coréia do Sul, 03080
- Seoul National University Hospital
-
Seoul, Coréia do Sul, 05505
- Asan Medical Center
-
Seoul, Coréia do Sul, (0)6351
- Samsung Medical Center
-
-
-
-
-
Barcelona, Espanha, 08035
- Hospital Universitari Vall d'Hebron
-
Barcelona, Espanha, 08041
- Hospital de la Santa Creu i Sant Pau
-
Barcelona, Espanha, 08036
- Hospital Clínic i Provincial
-
Madrid, Espanha, 28040
- Hospital Clinico San Carlos
-
Madrid, Espanha, 28041
- Hospital Universitario 12 de Octubre
-
Madrid, Espanha, 28046
- Hospital Universitario La Paz
-
Madrid, Espanha, 28034
- Hospital Ramon y Cajal
-
Valencia, Espanha, 46009
- Instituto Valenciano Oncologia
-
Valencia, Espanha, 46010
- Hospital Clinico Universitario de Valencia
-
-
Barcelona
-
Sabadell, Barcelona, Espanha, 08208
- Corporacio Sanitaria Parc Tauli
-
-
Cantabria
-
Santander, Cantabria, Espanha, 39008
- Hospital Universitario Marques de Valdecilla
-
-
Cordoba
-
Córdoba, Cordoba, Espanha, 14004
- Hospital Universitario Reina Sofia
-
-
Guipuzcoa
-
Donostia / San Sebastian, Guipuzcoa, Espanha, 20080
- Hospital de Donostia
-
-
-
-
Florida
-
Rockledge, Florida, Estados Unidos, 32955
- Cancer Care Centers of Brevard
-
-
Ohio
-
Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Estados Unidos, 15212
- AHN Cancer Institute ? Allegheny General Hospital
-
-
-
-
-
Angers, França, 49055
- ICO Paul Papin
-
Avignon, França, 84918
- Institut Sainte Catherine
-
Bordeaux, França, 33075
- Hopital Saint Andre
-
Clermont-Ferrand, França, 63011
- Centre Jean Perrin
-
Lyon, França, 69373
- Centre Léon Bérard
-
Nancy, França, 54100
- Centre D'Oncologie de Gentilly
-
Paris, França, 75674
- Institut Mutualiste Montsouris
-
Suresnes, França, 92151
- Hopital Foch
-
Toulouse, França, 31059
- Institut Claudius Régaud
-
Villejuif, França, 94805
- Institut Gustave Roussy
-
-
-
-
-
Ahens, Grécia, 124 64
- Attikon University General Hospital
-
Athens, Grécia, 115 28
- Alexandras General Hospital of Athens
-
Larissa, Grécia, 411 10
- University Hospital of Larissa
-
Pátrai, Grécia, 265 04
- University Hospital of Patras Medical Oncology
-
Thessaloniki, Grécia, 54007
- Theageneio Hospital
-
-
-
-
-
Hong Kong, Hong Kong
- Queen Mary Hospital
-
-
-
-
-
Cork, Irlanda
- Cork Uni Hospital
-
Dublin, Irlanda, D24 NR0A
- Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital
-
-
-
-
-
Tel Aviv, Israel, 6423906
- Tel Aviv Sourasky Medical Ctr
-
-
-
-
Campania
-
Naples, Campania, Itália, 80131
- Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli", Day Hospital Oncologico
-
Naples, Campania, Itália, 80131
- Istituto Nazionale Tumori Irccs Fondazione G. Pascale
-
-
Emilia-Romagna
-
Bologna, Emilia-Romagna, Itália, 40138
- AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica
-
-
Lazio
-
Rome, Lazio, Itália, 00168
- Policlinico Universitario "Agostino Gemelli"
-
-
Liguria
-
Genoa, Liguria, Itália, 16132
- A.O. Universitaria S. Martino Di Genova
-
-
Lombardy
-
Milan, Lombardy, Itália, 20133
- Irccs Istituto Nazionale Dei Tumori (Int)
-
Milan, Lombardy, Itália, 20141
- Istituto Europeo Di Oncologia
-
Milan, Lombardy, Itália, 20132
- Irccs Ospedale San Raffaele
-
-
Piedmont
-
Orbassano, Piedmont, Itália, 10043
- A.O. Universitaria S. Luigi Gonzaga
-
-
Tuscany
-
Arezzo, Tuscany, Itália, 52100
- Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato
-
-
Veneto
-
Padova, Veneto, Itália, 35128
- IOV - Istituto Oncologico Veneto - IRCCS
-
-
-
-
-
Aichi, Japão, 466-8560
- Nagoya University Hospital
-
Chiba, Japão, 260-8717
- Chiba Cancer Center
-
Chiba, Japão, 285-8741
- Toho University Sakura Medical Center
-
Ehime, Japão, 791-0280
- Shikoku Cancer Center
-
Hiroshima, Japão, 730-8518
- Hiroshima City Hiroshima Citizens Hospital
-
Hiroshima, Japão, 721-8511
- Fukuyama City Hospital
-
Hokkaido, Japão, 003-0804
- National Hospital Organization Hokkaido Cancer Center
-
Ibaraki, Japão, 305-8576
- University of Tsukuba Hospital
-
Kanagawa, Japão, 216-8511
- St. Marianna University Hospital
-
Kanagawa, Japão, 238-8558
- Yokosuka Kyosai Hospital
-
Kyoto, Japão, 606-8507
- Kyoto University Hospital
-
Nagano, Japão, 381-8551
- Nagano Municipal Hospital
-
Numakunai, Japão, 028-3695
- Iwate Medical University Hospital
-
Osaka, Japão, 541-8567
- Osaka International Cancer Institute
-
Saitama, Japão, 350-1298
- Saitama Medical University International Medical Center
-
Saitama, Japão, 362-0806
- Saitama Cancer Center
-
Shizuoka, Japão, 411-8777
- Shizuoka Cancer Center
-
Tokushima, Japão, 770-8503
- Tokushima University Hospital
-
Tokyo, Japão, 104-0045
- National Cancer Center Hospital
-
Tokyo, Japão, 160-8582
- Keio University Hospital
-
Toyama, Japão, 930-0194
- Toyama University Hospital
-
-
-
-
-
Krakow, Polônia, 30-727
- PRATIA MCM Kraków
-
Poznan, Polônia, 60-569
- Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu
-
Warsaw, Polônia, 04-073
- Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
-
Wroclaw, Polônia
- Dolnoslaskie Centrum Onkologii
-
-
-
-
-
Cambridge, Reino Unido, CB2 0QQ
- Addenbrookes Hospital
-
Edinburgh, Reino Unido, EH4 2XU
- Western General Hospital
-
London, Reino Unido, W6 8RF
- Charing Cross Hospital
-
London, Reino Unido, SW3 6JJ
- Royal Marsden Hospital - London
-
London, Reino Unido, NW1 2PG
- University College London NHS Foundation Trust
-
London, Reino Unido, EC1M 6BQ
- Barts Hospital
-
Plymouth, Reino Unido, PL6 8DH
- Derriford Hospital
-
Preston, Reino Unido, PR2 9HT
- Royal Preston Hospital
-
Sheffield, Reino Unido, S10 2SJ
- Weston Park Hospital
-
Southampton, Reino Unido, SO16 6YD
- Southampton University Hospitals NHS Trust
-
Sutton, Reino Unido, SM2 5PT
- Royal Marsden Hospital (Sutton)
-
-
-
-
-
Ivanovo, Rússia, 153040
- Ivanovo Regional Oncology Dispensary
-
-
Leningrad
-
Kuzmolovo, Leningrad, Rússia, 188663
- St-Petersburg Regional Oncology Dispensary
-
-
Niznij Novgorod
-
Nizhny Novgorod, Niznij Novgorod, Rússia, 603001
- Privolzhsk Regional Medical Center
-
-
Sankt-Peterburg
-
Saint Petersburg, Sankt-Peterburg, Rússia, 197758
- FSI Russian Centre of Radiology and Surgical Technologies
-
-
-
-
-
Olomouc, Tcheca, 779 00
- Fakultni nemocnice Olomouc
-
Prague, Tcheca, 150 06
- Fakultni nemocnice v Motole
-
Praha 4 - Krc, Tcheca, 140 59
- Fakultni Thomayerova nemocnice
-
-
-
-
-
Adana, Turquia (Türkiye), 01230
- Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital
-
Ankara, Turquia (Türkiye), 06700
- Ankara University Faculty of Medicine Cebeci Hospital
-
Bakirkoy / Istanbul, Turquia (Türkiye), 34147
- Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
-
Cordaleo, Turquia (Türkiye), 35575
- Medikal Park Izmir Hospital
-
Edirne, Turquia (Türkiye), 22030
- Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
-
Istanbul, Turquia (Türkiye), 34098
- Istanbul University Cerrahpasa Faculty of Medicine
-
Istanbul, Turquia (Türkiye), 34730
- Medeniyet University Goztepe Training and Research Hospital.
-
Samsun, Turquia (Türkiye), 55200
- Medikal Park Samsun
-
-
-
-
-
Dnipropetrovsk, Ucrânia, 49102
- CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR
-
Kyiv, Ucrânia, 03115
- Kyiv City Clinical Oncological Center
-
-
KIEV Governorate
-
Dnipro, KIEV Governorate, Ucrânia, 49005
- ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
-
Lviv, KIEV Governorate, Ucrânia, 79010
- Lviv Regional Clinical Hospital
-
-
Kharkiv Governorate
-
Kharkiv, Kharkiv Governorate, Ucrânia, 61037
- Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Inclusion Criteria for the Surveillance Phase:
- Histologically confirmed MIUC (also termed transitional cell carcinoma [TCC]) of the bladder
- Tumor, nodes, and metastases (TNM) classification (based on American Joint Committee on Cancer [AJCC] Cancer Staging Manual, 8th Edition; Amin et al. 2016) at pathological examination of surgical resection specimen as follows: For participants treated with prior neoadjuvant chemotherapy (NAC): tumor stage of ypT2-4a or ypN+ and M0. For participants who have not received prior NAC: tumor stage of pT2-4a or pN+ and M0
- Surgical resection of MIUC of the bladder
- Participants who have not received prior platinum-based NAC must be ineligible for cisplatin-based adjuvant chemotherapy, have refused it, or will not receive it based on physician's decision
- ctDNA assay developed based on tumor tissue specimen and matched normal DNA from blood
- Tumor programmed death ligand (PD-L1) expression per immunohistochemistry (IHC) that is evaluable by central testing of a representative tumor tissue specimen
- Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest no more than 4 weeks prior to enrollment
- Full recovery from cystectomy and enrollment within 24 weeks following cystectomy. Minimum of 6 weeks must have elapsed from surgery
Additional Inclusion Criteria for the Treatment Phase:
- Blood for plasma ctDNA sample evaluated to be ctDNA positive, defined as the presence of two or more mutations out of the 16 mutations identified based on participant' whole exome sequencing (WES) evaluable (ctDNA assay designability) report
- Absence of residual disease and absence of metastasis, as confirmed by a negative baseline CT or MRI scan of the pelvis, abdomen, and chest no more than 28 days prior to randomization, as assessed by the investigator and Independent Review Facility
- Eastern cooperative oncology group (ECOG) performance status of ≤ 2
- Life expectancy ≥12 weeks
- Adequate hematologic and end-organ function
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs
Exclusion Criteria:
General Medical Exclusion Criteria for the Surveillance Phase:
- Known PD-L1 IHC result for adjuvant therapy. The decision for the adjuvant therapy should not be based on the PD-L1 IHC result
- Pregnancy or breastfeeding
- Positive test for human immunodeficiency virus (HIV), with the following exception: Participants with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy, have a cluster of differentiation 4 (CD4) count ≥ 200 per microliter (/µL), and have an undetectable viral load
- Participants with active hepatitis B virus (HBV) or hepatitis C virus (HCV). Participants with past HBV infection or resolved HBV infection are eligible. A negative HBV deoxyribonucleic acid (DNA) test must be obtained in these participants prior to enrollment. Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA
- Active tuberculosis (TB) confirmed by a test performed within 3 months prior to treatment initiation
- 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. Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study. Participants with controlled type I diabetes mellitus (T1DM) on a stable dose of insulin regimen may be eligible for this study
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction (MI) within the previous 3 months, unstable arrhythmias, or unstable angina
Cancer-Specific Exclusion Criteria for the Surveillance Phase:
- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to study enrollment
- Adjuvant chemotherapy or radiation therapy for UC following cystectomy
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or 5 half-lives of the drug, whichever is longer, prior to enrollment
- Malignancies other than UC within 5 years prior to study enrollment
Additional Exclusion Criteria for the Treatment Phase:
- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to randomization to the treatment phase. Hormone-replacement therapy or oral contraceptives are allowed
- Adjuvant chemotherapy or radiation therapy for UC following cystectomy
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or 5 half-lives of the drug, whichever is longer, prior to randomization to the treatment phase
- Positive test for HIV, with the following exception: Participants with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy, have a CD4 count ≥200/μL, and have an undetectable viral load
- Participants with active HBV or HCV
- Active tuberculosis confirmed by a test performed within 3 months prior to treatment initiation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Arm A: Atezolizumab
Atezolizumab will be administered intravenously (IV) 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 disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor. |
ctDNA positive participants will receive 1680 mg IV, every 4 weeks (Q4W) on Day 1 of each 28-day cycle.
Outros nomes:
Signatera will be used to evaluate whether ctDNA is detected during serial monitoring of peripheral blood samples for participants enrolled in surveillance. Participants with a ctDNA positive result will be screened for inclusion in the treatment phase. Participants who remain ctDNA negative at 12 months from the date of cystectomy will not be randomized to treatment and will enter surveillance follow-up. |
|
Comparador de Placebo: Arm B: Placebo
Placebo will be administered IV on Day 1 of each 28-day cycle. Placebo will be discontinued in the event of disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor. Following the primary analysis, participants randomized to the comparator arm might discontinue placebo and may receive treatment outside the study at the investigator's discretion. |
Signatera will be used to evaluate whether ctDNA is detected during serial monitoring of peripheral blood samples for participants enrolled in surveillance. Participants with a ctDNA positive result will be screened for inclusion in the treatment phase. Participants who remain ctDNA negative at 12 months from the date of cystectomy will not be randomized to treatment and will enter surveillance follow-up. ctDNA positive participants will receive placebo IV, Q4W on Day 1 of each 28-day cycle |
|
Experimental: Arm C: Surveillance Follow-Up
Participants who remain ctDNA negative at 12 months from the date of cystectomy will not be randomized to treatment and will enter surveillance follow-up. |
Signatera will be used to evaluate whether ctDNA is detected during serial monitoring of peripheral blood samples for participants enrolled in surveillance. Participants with a ctDNA positive result will be screened for inclusion in the treatment phase. Participants who remain ctDNA negative at 12 months from the date of cystectomy will not be randomized to treatment and will enter surveillance follow-up. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
INV-assessed Disease-free Survival (DFS)
Prazo: From randomization to the first occurrence of a DFS event (Up to 48.2 months)
|
INV-assessed DFS was 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; or death from any cause. Participants without an INV-assessed DFS event were censored at the last date the participant was assessed to be alive and recurrence-free as determined with radiographic evidence. Kaplan-Meier (KM) methodology was used to estimate the median DFS. |
From randomization to the first occurrence of a DFS event (Up to 48.2 months)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Survival (OS)
Prazo: From randomization to death from any cause (Up to 48.2 months)
|
OS was defined as the time from randomization to death from any cause. Data for participants who did not die at the time of analysis were censored at the date last known to be alive. Data for participants who did not have post-baseline information were censored at the date of randomization. KM methodology was used to estimate the median OS. |
From randomization to death from any cause (Up to 48.2 months)
|
|
Independent Review Facility (IRF)-Assessed DFS
Prazo: From randomization to the first occurrence of a DFS event (Up to 48.2 months)
|
IRF-assessed DFS was defined as the time from randomization to the first occurrence of a DFS event, defined as any of the following: 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. Participants without an IRF-assessed DFS event were censored at the last date the participant was assessed to be alive and recurrence-free as determined with radiographic evidence. KM methodology was used to estimate the median DFS. |
From randomization to the first occurrence of a DFS event (Up to 48.2 months)
|
|
INV-assessed Disease-specific Survival (DSS)
Prazo: From randomization to death from UC (Up to 48.2 months)
|
INV-assessed DSS was defined as the time from randomization to death from UC per investigator assessment of cause of death. Data for participants who did not die will be censored at the last date they were known to be alive. Data for participants who died from causes other than bladder cancer were censored at the date of death. KM methodology was used to estimate the median DSS. |
From randomization to death from UC (Up to 48.2 months)
|
|
INV-assessed Distant Metastasis-free Survival (DMFS)
Prazo: From randomization to the first occurrence of a DMFS event (Up to 48.2 months)
|
INV-assessed DMFS was defined as the time from randomization to the first occurrence of a DMFS event, defined as diagnosis of distant (i.e., non-locoregional) metastasis or death from any cause. Data for participants without a DMFS event were censored at the last date the participant was assessed to be alive and free of distant metastasis. Data for participants with no post-baseline disease assessment were censored at the randomization date. KM methodology was used to estimate the median DMFS. |
From randomization to the first occurrence of a DMFS event (Up to 48.2 months)
|
|
Time to Confirmed Deterioration (TTCD) in Physical Functioning, Role Functioning & Global Health Status/Quality of Life (GHS/QoL), Assessed by European Organisation for Research & Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Prazo: Up to 11.8 months
|
TTCD of physical functioning (PF), role functioning (RF) & health-related quality of life (HRQoL) was defined as time from randomization to first documented confirmed deterioration. Confirmed deterioration=participant's first ≥10-point score decrease from baseline on EORTC QLQ C30 PF, RF or GHS/QoL scale that must be held for ≤2 consecutive time points or followed by death due to cancer progression within 8 weeks from last patient-reported outcomes (PRO) assessment. EORTC QLQ-C30 has 30 questions assessing 5 aspects of participant functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting & pain), GHS/QoL & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). Functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much) & GHS/QoL on a 7-point scale (1=very poor to 7=excellent). Scores are linearly transformed on a scale of 0 to 100. High score=better functioning/better QoL. |
Up to 11.8 months
|
|
Percentage of Participants With ctDNA Clearance
Prazo: Baseline, Day 1 of Cycles 3 or 5 (Cycle length = 28 days)
|
ctDNA clearance was defined as the percentage of participants who were ctDNA positive at baseline and ctDNA negative at Cycle 3, Day 1 or Cycle 5, Day 1. Percentages have been rounded off. |
Baseline, Day 1 of Cycles 3 or 5 (Cycle length = 28 days)
|
|
Number of Participants With Adverse Events (AEs)
Prazo: From initiation of study treatment up to approximately 5 years
|
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
From initiation of study treatment up to approximately 5 years
|
|
Maximum Serum Concentration (Cmax) of Atezolizumab
Prazo: 30 minutes post dose on Cycle 1 Day 1 (Cycle length = 28 days)
|
30 minutes post dose on Cycle 1 Day 1 (Cycle length = 28 days)
|
|
|
Minimum Serum Concentration (Cmin) of Atezolizumab
Prazo: Pre-dose on Day 1 of Cycles 2, 3, 4, 8 and 12 (Cycle length = 28 days)
|
Pre-dose on Day 1 of Cycles 2, 3, 4, 8 and 12 (Cycle length = 28 days)
|
|
|
Number of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab
Prazo: Up to 12.8 months
|
Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample have been reported here. |
Up to 12.8 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Clinical Trials, Hoffmann-La Roche
Publicações e links úteis
Publicações Gerais
- Jackson-Spence F, Toms C, O'Mahony LF, Choy J, Flanders L, Szabados B, Powles T. IMvigor011: a study of adjuvant atezolizumab in patients with high-risk MIBC who are ctDNA+ post-surgery. Future Oncol. 2023 Mar;19(7):509-515. doi: 10.2217/fon-2022-0868. Epub 2023 Apr 21.
- Powles T, Kann AG, Castellano D, Gross-Goupil M, Nishiyama H, Bracarda S, Bjerggaard Jensen J, Makaroff L, Jiang S, Ku JH, Park SH, Reig Torras O, Ye D, Maruzzo M, Necchi A, Morales-Barrera R, Giunta EF, Lee JL, Tortora G, Urun Y, Dolowy L, Erdem D, Pinto A, Grando F, Zou W, Assaf ZJ, Vuky J, Degaonkar V, Steinberg EE, Bellmunt J, Gschwend JE; IMvigor011 Investigators. ctDNA-Guided Adjuvant Atezolizumab in Muscle-Invasive Bladder Cancer. N Engl J Med. 2025 Dec 18;393(24):2395-2408. doi: 10.1056/NEJMoa2511885. Epub 2025 Oct 20.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- BO42843
- 2020-004418-36 (Número EudraCT)
- 2022-502705-15-00 (Ctis)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .