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BRIEF TITLE: Atezolizumab (Anti-PDL1 Antibody) Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy

A Phase III, Double-Blind, Multicenter, Randomized Study of Atezolizumab (Anti-PDL1 Antibody) Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy


  • Org Study ID: BO42843
  • Secondary ID:
  • NCT ID: NCT04660344
  • NCT Alias:
  • Sponsor: Hoffmann-La Roche - Industry
  • Source: Hoffmann-La Roche

Brief 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.

Overal Status Start Date Phase Study Type
Recruiting April 25, 2021 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: IRF-assessed DFS in Participants Who Are ctDNA Positive Within 20 Weeks of Cystectomy

Primary Outcome 1 - Time Frame: Randomization up to first occurrence of DFS event (up to approximately 73 months)

Condition:

  • Muscle-invasive Bladder Cancer

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, 7th Edition; Edge et al.
2010) 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 pT3-4a or pN+ and M0

- Surgical resection of MIUC of the bladder

- 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 and confirmed diagnosis of MIUC as documented through
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 14 weeks following cystectomy.
Minimum of 6 weeks must have elapsed from surgery.

Additional Inclusion Criteria for the Treatment Phase:

- Plasma sample evaluated to be ctDNA positive

- 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 4 weeks 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:

- Pregnancy or breastfeeding

- 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.

- Positive test for HIV

- Patients with active hepatitis B virus or hepatitis C

- Active tuberculosis

- 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:

- 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Reference Study ID Number: BO42843 www.roche.com/about_roche/roche_worldwide.htm

Phone: 888-662-6728 (U.S. and Canada)

Email: global.rochegenentechtrials@roche.com

Locations

Facility Status Contact
Mayo Clinic - Arizona
Phoenix, Arizona 85054
United States
Not yet recruiting
Sansum Clinic
Santa Barbara, California 93105
United States
Not yet recruiting
UCLA Cancer Center; Premiere Oncology, A Medical Corporation
Santa Monica, California 90404
United States
Not yet recruiting
Rocky Mountain Cancer Center - Denver
Littleton, Colorado 80120
United States
Not yet recruiting
Woodlands Medical Specialists, P.A.
Pensacola, Florida 32503
United States
Not yet recruiting
Cancer Care Centers of Brevard
Rockledge, Florida 32955
United States
Not yet recruiting
Urology Cancer Center & GU Research Network
Omaha, Nebraska 68130
United States
Not yet recruiting
Optum Health Care
Las Vegas, Nevada 89106
United States
Not yet recruiting
University of Rochester
Rochester, New York 14642
United States
Not yet recruiting
Duke Cancer Institute
Durham, North Carolina 27710
United States
Not yet recruiting
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157
United States
Not yet recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United States
Not yet recruiting
Texas Oncology Cancer Center
Austin, Texas 78731
United States
Not yet recruiting
Texas Oncology-Medical City Dallas
Dallas, Texas 75230
United States
Not yet recruiting
Texas Oncology-Denton South
Denton, Texas 76201
United States
Not yet recruiting
Texas Oncology - Houston (Gessner)
Houston, Texas 77024
United States
Not yet recruiting
Texas Oncology - Willowbrook
Houston, Texas 77070
United States
Not yet recruiting
Texas Oncology P.A. (McKinney)
McKinney, Texas 75071
United States
Not yet recruiting
AZ KLINA
Brasschaat, 2930
Belgium
Not yet recruiting
UZ Gent
Gent, 9000
Belgium
Not yet recruiting
AZ Delta (Campus Rumbeke)
Roeselare, 8800
Belgium
Not yet recruiting
Oncocentro Serviços Medicos E Hospitalares Ltda
Fortaleza, CE 60130-241
Brazil
Not yet recruiting
Crio - Centro Regional Integrado de Oncologia
Fortaleza, CE 60336-550
Brazil
Not yet recruiting
CETUS Hospital Dia Oncologia
Belo Horizonte, MG 30110022
Brazil
Not yet recruiting
Hospital Erasto Gaertner
Curitiba, PR 81520-060
Brazil
Not yet recruiting
Hospital Moinhos de Vento
Porto Alegre, RS 90035-001
Brazil
Not yet recruiting
Hospital Sao Lucas - PUCRS
Porto Alegre, RS 90610-000
Brazil
Not yet recruiting
Hospital Nossa Senhora da Conceicao
Porto Alegre, RS 91350-200
Brazil
Not yet recruiting
Clinica Viver
Santa Maria, RS 97015-373
Brazil
Not yet recruiting
Centro de Pesquisas Oncologicas - CEPON
Florianopolis, SC 88034-000
Brazil
Not yet recruiting
*X*Fundação Pio XII Hospital de Câncer de Barretos
Barretos, SP 14784-400
Brazil
Not yet recruiting
Hospital Amaral Carvalho
Jau, SP 17210-120
Brazil
Not yet recruiting
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo, SP 01246-000
Brazil
Not yet recruiting
Hospital Alemao Oswaldo Cruz; Pesquisa Clinica
Sao Paulo, SP 01323-020
Brazil
Not yet recruiting
Hospital Beneficência Portuguesa
São Paulo, SP 01323-000
Brazil
Not yet recruiting
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
Canada
Not yet recruiting
Health Sciences North
Sudbury, Ontario P3E 5J1
Canada
Not yet recruiting
Sunnybrook Research Institute
Toronto, Ontario M4N 3M5
Canada
Not yet recruiting
Princess Margaret Cancer Center
Toronto, Ontario M5G 1Z5
Canada
Not yet recruiting
Jewish General Hospital
Montreal, Quebec H3T 1E2
Canada
Not yet recruiting
CHU de Québec - Université Laval - Hôtel-Dieu de Québec
Quebec, G1R 2J6
Canada
Not yet recruiting
Peking University First Hospital
Beijing City, 100034
China
Not yet recruiting
Friendship Hospital, Capital Medical University
Beijing, 100050
China
Not yet recruiting
the First Hospital of Jilin University
Changchun, 130021
China
Not yet recruiting
Hu Nan Provincial Cancer Hospital
Changsha, 410006
China
Not yet recruiting
The First Affiliated Hospital of Fujian Medical University
Fu Zhou, 350005
China
Not yet recruiting
Fujian Medical University Union Hospital
Fujian, 350001
China
Not yet recruiting
The Second Affiliated Hospital, Sun Yat-sen University
Guangzhou City, 510120
China
Not yet recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120
China
Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, 150081
China
Not yet recruiting
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing City, 210029
China
Not yet recruiting
Jiangsu Cancer Hospital
Nanjing City, 211100
China
Not yet recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai City, 200040
China
Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai City, 200120
China
Not yet recruiting
Zhongshan Hospital Fudan University
Shanghai, 200032
China
Not yet recruiting
Liaoning cancer Hospital & Institute
Shenyang, 110042
China
Not yet recruiting
Tianjin Cancer Hospital
Tianjin, 300060
China
Not yet recruiting
Xinjiang Medical University Cancer Hospital
Urumqi City, 830011
China
Not yet recruiting
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, 779 00
Czechia
Not yet recruiting
Thomayerova nemocnice; Onkologicka klinika 1. LF UK A TN
Praha 4 - Krc, 140 59
Czechia
Not yet recruiting
Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol
Praha 5, 150 06
Czechia
Not yet recruiting
ICO Paul Papin; Oncologie Medicale.
Angers, 49055
France
Not yet recruiting
Institut Sainte Catherine;Recherche Clinique
Avignon, 84918
France
Not yet recruiting
CHU Besançon - Hôpital Jean Minjoz
Besançon Cedex, 25030
France
Not yet recruiting
Hopital Saint Andre
Bordeaux, 33075
France
Not yet recruiting
Centre Jean Perrin
Clermont Ferrand, 63011
France
Not yet recruiting
Centre D'Oncologie de Gentilly; Oncology
Nancy, 54100
France
Not yet recruiting
Centre Antoine Lacassagne
Nice, 06189
France
Not yet recruiting
Institut Mutualiste Montsouris; Oncologie
Paris, 75674
France
Not yet recruiting
Hopital Foch; Oncologie
Suresnes, 92151
France
Not yet recruiting
Universitätsklinikum Düsseldorf; Urologische Klinik
Düsseldorf, 40225
Germany
Not yet recruiting
Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
Halle (Saale), 06120
Germany
Not yet recruiting
Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik
Herne, 44625
Germany
Not yet recruiting
Universitätsklinikum Jena, Urologische Klinik und Poliklinik
Jena, 07743
Germany
Not yet recruiting
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
München, 81675
Germany
Not yet recruiting
Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie
Münster, 48149
Germany
Not yet recruiting
Universitätsklinikum Tübingen; Klinik für Urologie
Tübingen, 72076
Germany
Not yet recruiting
Universitätsklinikum Ulm; Klinik für Urologie
Ulm, 89081
Germany
Not yet recruiting
Universitätsklinikum Würzburg; Klinik und Poliklinik für Urologie und Kinderurologie
Würzburg, 97080
Germany
Not yet recruiting
Alexandras General Hospital of Athens; Oncology Department
Athens, 115 28
Greece
Not yet recruiting
Attikon University General Hospital
Athens, 124 64
Greece
Not yet recruiting
University Hospital of Larissa;Department of Medical Oncology
Larissa, 411 10
Greece
Not yet recruiting
University Hospital of Patras Medical Oncology
Patras, 265 04
Greece
Not yet recruiting
Theageneio Hospital
Thessaloniki, 54007
Greece
Not yet recruiting
Cork Uni Hospital; Oncology Dept
Cork,
Ireland
Not yet recruiting
Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit
Dublin, 24
Ireland
Not yet recruiting
St Vincents University Hospital
Dublin,
Ireland
Not yet recruiting
Rambam Medical Center; Oncology
Haifa, 3109601
Israel
Not yet recruiting
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, 9112000
Israel
Not yet recruiting
Rabin Medical Center; Oncology Dept
Petach Tikva, 4941492
Israel
Not yet recruiting
Ichilov Sourasky Medical Center; Heamatology
Tel Aviv, 6423906
Israel
Not yet recruiting
Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli", Day Hospital Oncologico
Napoli, Campania 80131
Italy
Not yet recruiting
ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
Napoli, Campania 80131
Italy
Not yet recruiting
AZ.Osp S. Orsola - Malpighi-Reparto di Oncologia Medica
Bologna, Emilia-Romagna 40138
Italy
Not yet recruiting
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna 47014
Italy
Not yet recruiting
Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
Roma, Lazio 00168
Italy
Not yet recruiting
A.O. Universitaria S. Martino Di Genova
Genova, Liguria 16132
Italy
Not yet recruiting
Istituto Europeo Di Oncologia
Milano, Lombardia 20141
Italy
Not yet recruiting
A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica
Orbassano, Piemonte 10043
Italy
Not yet recruiting
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
Arezzo, Toscana 52100
Italy
Not yet recruiting
Azienda Ospedaliera Santa Maria di Terni
Terni, Umbria 20089
Italy
Not yet recruiting
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padova, Veneto 35128
Italy
Not yet recruiting
Kyushu University Hospital
Fukuoka, 812-8582
Japan
Not yet recruiting
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518
Japan
Not yet recruiting
National Hospital Organization Hokkaido Cancer Center
Hokkaido, 003-0804
Japan
Not yet recruiting
University of Tsukuba Hospital
Ibaraki, 305-8576
Japan
Not yet recruiting
Iwate Medical University Hospital
Iwate, 028-3695
Japan
Not yet recruiting
St. Marianna University School of Medicine Hospital
Kanagawa, 216-8511
Japan
Not yet recruiting
Kyoto University Hospital
Kyoto, 606-8507
Japan
Not yet recruiting
Okayama University Hospital
Okayama, 700-8558
Japan
Not yet recruiting
Osaka International Cancer Institute
Osaka, 541-8567
Japan
Not yet recruiting
Osaka University Hospital
Osaka, 565-0871
Japan
Not yet recruiting
Saitama Medical University International Medical Center
Saitama, 350-1298
Japan
Not yet recruiting
Saitama Cancer Center
Saitama, 362-0806
Japan
Not yet recruiting
Shizuoka Cancer Center
Shizuoka, 411-8777
Japan
Not yet recruiting
Tokushima University Hospital
Tokushima, 770-8503
Japan
Not yet recruiting
National Cancer Center Hospital
Tokyo, 104-0045
Japan
Not yet recruiting
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550
Japan
Not yet recruiting
Keio University Hospital
Tokyo, 160-8582
Japan
Not yet recruiting
Kyungpook National University Chilgok Hospital
Daegu, 41404
Korea, Republic of
Recruiting
National Cancer Center
Goyang-si, 10408
Korea, Republic of
Recruiting
Samsung Medical Center
Seoul, (0)6351
Korea, Republic of
Not yet recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic of
Recruiting
Asan Medical Center
Seoul, 05505
Korea, Republic of
Recruiting
Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
Brzozów, 36-200
Poland
Not yet recruiting
Szpital Uniwersytecki Nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy; Klinika Urologii i Onkologicznej
Bydgoszcz, 85-094
Poland
Not yet recruiting
PRATIA MCM Kraków
Kraków, 30-510
Poland
Not yet recruiting
Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego; Chemotherapy
Poznań, 60-569
Poland
Not yet recruiting
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.
Warszawa, 04-073
Poland
Not yet recruiting
Dolnoslaskie Centrum Onkologii
Wrocław, 53-413
Poland
Not yet recruiting
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi
Łódź, 93-513
Poland
Not yet recruiting
FSBI National Medical Research Radiological Center; A. TSYB MEDICAL RADIOLOGICAL RESEARCH CENTER
Obninsk, Kaluga 249036
Russian Federation
Not yet recruiting
St-Petersburg Regional Oncology Dispensary; Oncology
Kuzmolovo, 188663
Russian Federation
Not yet recruiting
FSBSI "N. N. Blokhin Russian Cancer Research Center"
Moscow, 115478
Russian Federation
Not yet recruiting
Russian Scientific Center of Roentgenoradiology
Moscow, 117997
Russian Federation
Not yet recruiting
Privolzhsk Regional Medical Center
Nizhny Novgorod, 603001
Russian Federation
Not yet recruiting
FSI Russian Centre of Radiology and Surgical Technologies
Saint-Petersburg, 197758
Russian Federation
Not yet recruiting
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona 8208
Spain
Not yet recruiting
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba 14004
Spain
Not yet recruiting
Hospital de Donostia; Servicio de Oncologia Medica
San Sebastian, Guipuzcoa 20080
Spain
Not yet recruiting
Hospital Universitari Vall d'Hebron; Oncology
Barcelona, 08035
Spain
Not yet recruiting
Hospital Clínic i Provincial; Servicio de Oncología
Barcelona, 08036
Spain
Not yet recruiting
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, 08041
Spain
Recruiting
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, 28007
Spain
Not yet recruiting
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, 28034
Spain
Recruiting
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid, 28040
Spain
Recruiting
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 28041
Spain
Recruiting
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, 28046
Spain
Recruiting
Instituto Valenciano Oncologia; Oncologia Medica
Valencia, 46009
Spain
Recruiting
Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
Kharkiv, Kharkiv Governorate 61037
Ukraine
Not yet recruiting
Lviv Regional Clinical Hospital
Lviv, KIEV Governorate 79010
Ukraine
Not yet recruiting
CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR
Dnipropetrovsk, 49102
Ukraine
Not yet recruiting
Kyiv City Clinical Oncological Center
Kyiv, 03115
Ukraine
Not yet recruiting
Belfast City Hospital
Belfast, BT9 7AB
United Kingdom
Not yet recruiting
Addenbrookes Hospital
Cambridge, CB2 0QQ
United Kingdom
Not yet recruiting
Western General Hospital
Edinburgh, EH4 2XU
United Kingdom
Not yet recruiting
St James Hospital; Dept of Oncology/Hematology
Leeds, LS9 7TF
United Kingdom
Not yet recruiting
Barts Hospital; Institute of Cancer
London, EC1M 6BQ
United Kingdom
Not yet recruiting
University College London NHS Foundation Trust
London, NW1 2PG
United Kingdom
Not yet recruiting
Derriford Hospital
Plymouth, PL6 8DH
United Kingdom
Not yet recruiting
Royal Preston Hospital
Preston, PR2 9HT
United Kingdom
Not yet recruiting
Weston Park Hospital
Sheffield, S10 2SJ
United Kingdom
Not yet recruiting
Southampton University Hospitals NHS Trust
Southampton, SO16 6YD
United Kingdom
Not yet recruiting
Royal Marsden Hospital (Sutton)
Sutton, SM2 5PT
United Kingdom
Not yet recruiting