Bladder Cancer Clinical Trial

A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy

Summary

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 ctDNA positive and are at high risk for recurrence following cystectomy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria for the Surveillance Phase:

Histologically confirmed MIUC (also termed TCC) of the bladder
TNM classification (based on AJCC Cancer Staging Manual, 8th Edition; Amin et al. 2016) at pathological examination of surgical resection specimen as follows: For patients treated with prior NAC: tumor stage of ypT2-4a or ypN+ and M0. For patients who have not received prior NAC: tumor stage of pT2-4a or pN+ and M0
Surgical resection of MIUC of the bladder
Patients who have received prior platinum-based NAC.
Patients who have not received prior platinum-based NAC, have refused, or are ineligible ("unfit") for cisplatin-based adjuvant chemotherapy.
ctDNA assay developed based on tumor tissue specimen and matched normal DNA from blood.
Tumor PD-L1 expression per 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 patient's 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.
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

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 HIV, with the following exception: Patients 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
Patients with active hepatitis B virus or hepatitis C. Patients with past HBV infection or resolved HBV infection are eligible. HBV DNA must be obtained in these patients prior to enrollment.

Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.

Active tuberculosis confirmed by a test performed within 3 months prior to treatment start.
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. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study. Patients with controlled Type I diabetes mellitus 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 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: Patients 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.
Patients with active hepatitis B virus or hepatitis C
Active tuberculosis confirmed by a test performed within 3 months prior to treatment initiation

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

495

Study ID:

NCT04660344

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 187 Locations for this study

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Sansum Clinic
Santa Barbara California, 93105, United States
Rocky Mountain Cancer Center - Denver
Littleton Colorado, 80120, United States
Woodlands Medical Specialists, P.A.
Pensacola Florida, 32503, United States
Cancer Care Centers of Brevard
Rockledge Florida, 32955, United States
Optum Health Care
Las Vegas Nevada, 89102, United States
Wake Forest Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
Texas Oncology Cancer Center
Austin Texas, 78731, United States
Texas Oncology-Medical City Dallas
Dallas Texas, 75230, United States
Texas Oncology-Denton South
Denton Texas, 76201, United States
Texas Oncology-Fort Worth 12th Ave
Fort Worth Texas, 76104, United States
Texas Oncology - Houston (Gessner)
Houston Texas, 77024, United States
Texas Oncology - Willowbrook
Houston Texas, 77070, United States
Texas Oncology P.A. (McKinney)
McKinney Texas, 75071, United States
Centro Medico Austral
Buenos Aires , 1019, Argentina
Instituto Alexander Fleming
Buenos Aires , 1426, Argentina
Cemic; Oncologia Clinica
Buenos Aires , C1431, Argentina
AZ KLINA
Brasschaat , 2930, Belgium
UZ Gent
Gent , 9000, Belgium
AZ Delta (Campus Rumbeke)
Roeselare , 8800, Belgium
Oncocentro Serviços Medicos E Hospitalares Ltda
Fortaleza CE, 60135, Brazil
Crio - Centro Regional Integrado de Oncologia
Fortaleza CE, 60336, Brazil
CETUS Hospital Dia Oncologia
Uberaba MG, 38082, Brazil
Hospital Erasto Gaertner
Curitiba PR, 81520, Brazil
Hospital Moinhos de Vento
Porto Alegre RS, 90035, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre RS, 90610, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre RS, 91350, Brazil
Clinica Viver
Santa Maria RS, 97015, Brazil
Centro de Pesquisas Oncologicas - CEPON
Florianopolis SC, 88034, Brazil
*X*Fundação Pio XII Hospital de Câncer de Barretos
Barretos SP, 14784, Brazil
Hospital Amaral Carvalho
Jau SP, 17210, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo SP, 01246, Brazil
Hospital Alemao Oswaldo Cruz; Pesquisa Clinica
Sao Paulo SP, 01323, Brazil
Beneficencia Portuguesa de Sao Paulo
São Paulo SP, 01321, Brazil
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Health Sciences North
Sudbury Ontario, P3E 5, Canada
Sunnybrook Research Institute
Toronto Ontario, M4N 3, Canada
Princess Margaret Cancer Center
Toronto Ontario, M5G 1, Canada
Peking University First Hospital
Beijing City , 10003, China
Friendship Hospital, Capital Medical University
Beijing , 10005, China
the First Hospital of Jilin University
Changchun , 13002, China
Hu Nan Provincial Cancer Hospital
Changsha , 41000, China
Chongqing Cancer Hospital
Chongqing , 40003, China
The First Affiliated Hospital of Fujian Medical University
Fu Zhou , 35000, China
Fujian Medical University Union Hospital
Fuzhou City , 35000, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou , 51012, China
Harbin Medical University Cancer Hospital
Harbin , 15008, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing City , 21000, China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing City , 21002, China
Jiangsu Cancer Hospital
Nanjing City , 21110, China
Huashan Hospital Affiliated to Fudan University
Shanghai City , 20004, China
Fudan University Shanghai Cancer Center
Shanghai City , 20012, China
Zhongshan Hospital Fudan University
Shanghai , 20003, China
Liaoning cancer Hospital & Institute
Shenyang , 11004, China
Tianjin Cancer Hospital
Tianjin , 30006, China
Xinjiang Medical University Cancer Hospital
Urumqi City , 83001, China
The First Affiliated Hospital of Xiamen University
Xiamen , 36100, China
Clinica del Country
Bogota , 11001, Colombia
Instituto Cancerologia Medellin; Clinica Las Americas
Medellin , 05002, Colombia
Oncomedica S.A.
Monteria , 23000, Colombia
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc , 779 0, Czechia
Thomayerova nemocnice; Onkologicka klinika 1. LF UK A TN
Praha 4 - Krc , 140 5, Czechia
Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol
Praha 5 , 150 0, Czechia
ICO Paul Papin; Oncologie Medicale.
Angers , 49055, France
Institut Sainte Catherine;Recherche Clinique
Avignon , 84918, France
CHU Besançon - Hôpital Jean Minjoz
Besançon Cedex , 25030, France
Hopital Saint Andre
Bordeaux , 33075, France
Centre Jean Perrin
Clermont Ferrand , 63011, France
Centre Léon Bérard; Centre régional; le cancer Rhône-Alpes
Lyon , 69373, France
Centre D'Oncologie de Gentilly; Oncology
Nancy , 54100, France
Centre Antoine Lacassagne
Nice , 06189, France
Institut Mutualiste Montsouris; Oncologie
Paris , 75674, France
Hopital Foch; Oncologie
Suresnes , 92151, France
Institut Claudius Régaud
Toulouse , 31059, France
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif , 94805, France
Universitätsklinikum Düsseldorf; Urologische Klinik
Düsseldorf , 40225, Germany
Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
Halle (Saale) , 06120, Germany
Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik
Herne , 44625, Germany
Universitätsklinikum Jena, Urologische Klinik und Poliklinik
Jena , 07743, Germany
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
München , 81675, Germany
Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie
Münster , 48149, Germany
Universitätsklinikum Tübingen; Klinik für Urologie
Tübingen , 72076, Germany
Universitätsklinikum Ulm; Klinik für Urologie
Ulm , 89081, Germany
Universitätsklinikum Würzburg; Klinik und Poliklinik für Urologie und Kinderurologie
Würzburg , 97080, Germany
Attikon University General Hospital
Ahens , 124 6, Greece
Alexandras General Hospital of Athens; Oncology Department
Athens , 115 2, Greece
University Hospital of Larissa;Department of Medical Oncology
Larissa , 411 1, Greece
University Hospital of Patras Medical Oncology
Patras , 265 0, Greece
Theageneio Hospital
Thessaloniki , 54007, Greece
Cork Uni Hospital; Oncology Dept
Cork , , Ireland
Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit
Dublin , 24, Ireland
St Vincents University Hospital
Dublin , , Ireland
Rambam Medical Center; Oncology
Haifa , 31096, Israel
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem , 91120, Israel
Rabin Medical Center; Oncology Dept
Petach Tikva , 49414, Israel
Tel Aviv Sourasky Medical Ctr; Oncology
Tel Aviv , 64239, Israel
Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli", Day Hospital Oncologico
Napoli Campania, 80131, Italy
ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
Napoli Campania, 80131, Italy
AZ.Osp S. Orsola - Malpighi-Reparto di Oncologia Medica
Bologna Emilia-Romagna, 40138, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola Emilia-Romagna, 47014, Italy
Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
Roma Lazio, 00168, Italy
A.O. Universitaria S. Martino Di Genova
Genova Liguria, 16132, Italy
Irccs Ospedale San Raffaele
Milano Lombardia, 20132, Italy
Istituto Europeo Di Oncologia
Milano Lombardia, 20141, Italy
A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica
Orbassano Piemonte, 10043, Italy
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
Arezzo Toscana, 52100, Italy
Azienda Ospedaliera Santa Maria di Terni
Terni Umbria, 20089, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padova Veneto, 35128, Italy
Nagoya University Hospital
Aichi , 466-8, Japan
Chiba Cancer Center
Chiba , 260-8, Japan
Toho University Sakura Medical Center
Chiba , 285-8, Japan
Shikoku Cancer Center
Ehime , 791-0, Japan
Kyushu University Hospital
Fukuoka , 812-8, Japan
Fukuyama City Hospital
Hiroshima , 721-8, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima , 730-8, Japan
National Hospital Organization Hokkaido Cancer Center
Hokkaido , 003-0, Japan
University of Tsukuba Hospital
Ibaraki , 305-8, Japan
Iwate Medical University Hospital
Iwate , 028-3, Japan
St. Marianna University Hospital
Kanagawa , 216-8, Japan
Yokosuka Kyosai Hospital
Kanagawa , 238-8, Japan
Kyoto University Hospital
Kyoto , 606-8, Japan
Nagano Municipal Hospital
Nagano , 381-8, Japan
Okayama University Hospital
Okayama , 700-8, Japan
Osaka International Cancer Institute
Osaka , 541-8, Japan
Osaka University Hospital
Osaka , 565-0, Japan
Saitama Medical University International Medical Center
Saitama , 350-1, Japan
Saitama Cancer Center
Saitama , 362-0, Japan
Shizuoka Cancer Center
Shizuoka , 411-8, Japan
Tokushima University Hospital
Tokushima , 770-8, Japan
National Cancer Center Hospital
Tokyo , 104-0, Japan
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan
Keio University Hospital
Tokyo , 160-8, Japan
Toyama University Hospital
Toyama , 930-0, Japan
Kyungpook National University Chilgok Hospital
Daegu , 41404, Korea, Republic of
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
Brzozów , 36-20, Poland
Szpital Uniwersytecki Nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy; Klinika Urologii i Onkologicznej
Bydgoszcz , 85-09, Poland
PRATIA MCM Kraków
Kraków , 30-51, Poland
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu; Oddział Chemioterapii
Poznań , 60-56, Poland
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.
Warszawa , 04-07, Poland
Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
Wrocław , 53-41, Poland
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi
Łódź , 93-51, Poland
FSBI National Medical Research Radiological Center; A. TSYB MEDICAL RADIOLOGICAL RESEARCH CENTER
Obninsk Kaluga, 24903, Russian Federation
Ivanovo Regional Oncology Dispensary
Ivanovo , 15304, Russian Federation
St-Petersburg Regional Oncology Dispensary; Oncology
Kuzmolovo , 18866, Russian Federation
Russian Scientific Center of Roentgenoradiology
Moscow , 11799, Russian Federation
Murmansk Regional Clinical Hospital named after P.A. Bayandin
Murmansk , 18304, Russian Federation
Privolzhsk Regional Medical Center
Nizhny Novgorod , 60300, Russian Federation
FSI Russian Centre of Radiology and Surgical Technologies
Saint-Petersburg , 19775, Russian Federation
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell Barcelona, 8208, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba Cordoba, 14004, Spain
Hospital de Donostia; Servicio de Oncologia Medica
San Sebastian Guipuzcoa, 20080, Spain
Hospital Universitari Vall d'Hebron; Oncology
Barcelona , 08035, Spain
Hospital Clínic i Provincial; Servicio de Oncología
Barcelona , 08036, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona , 08041, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid , 28007, Spain
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
Madrid , 28033, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid , 28034, Spain
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid , 28041, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid , 28046, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
Instituto Valenciano Oncologia; Oncologia Medica
Valencia , 46009, Spain
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
Adana , 01230, Turkey
Ankara University Faculty of Medicine Cebeci Hospital
Ankara , 06700, Turkey
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
Bakirkoy / Istanbul , 34147, Turkey
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne , 22030, Turkey
Istanbul University Cerrahpasa Faculty of Medicine
Istanbul , 34098, Turkey
Medeniyet University Goztepe Training and Research Hospital.
Kadiköy , 34722, Turkey
Medikal Park Izmir Hospital
Karşıyaka , 35575, Turkey
Medikal Park Samsun
Samsun , 55200, Turkey
Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
Kharkiv Kharkiv Governorate, 61037, Ukraine
ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
Dnipro KIEV Governorate, 49005, Ukraine
Lviv Regional Clinical Hospital
Lviv KIEV Governorate, 79010, Ukraine
CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR
Dnipropetrovsk , 49102, Ukraine
Kyiv City Clinical Oncological Center
Kyiv , 03115, Ukraine
Belfast City Hospital
Belfast , BT9 7, United Kingdom
Addenbrookes Hospital
Cambridge , CB2 0, United Kingdom
Western General Hospital
Edinburgh , EH4 2, United Kingdom
Barts Hospital; Institute of Cancer
London , EC1M , United Kingdom
University College London NHS Foundation Trust
London , NW1 2, United Kingdom
Royal Marsden Hospital - London
London , SW3 6, United Kingdom
Charing Cross Hospital
London , W6 8R, United Kingdom
Derriford Hospital
Plymouth , PL6 8, United Kingdom
Royal Preston Hospital
Preston , PR2 9, United Kingdom
Weston Park Hospital
Sheffield , S10 2, United Kingdom
Southampton University Hospitals NHS Trust
Southampton , SO16 , United Kingdom
Royal Marsden Hospital (Sutton)
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

495

Study ID:

NCT04660344

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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