AzTrials
AzTrials

Muscle-invasive Bladder CancerPhase 3IMvigor011NCT04660344

A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Participants With High-risk Muscle-invasive Bladder Cancer (MIBC) Who Are ctDNA Positive Following Cystectomy

A Phase 3 study testing Atezolizumab and Signatera in people with Muscle-invasive Bladder Cancer, run by Hoffmann-La Roche at 141 sites in 23 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 circulating tumour deoxyribonucleic acid (ctDNA) positive and are at high risk for recurrence… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Muscle-invasive Bladder Cancer
What is being tested?
Atezolizumab and Signatera
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
761 participants
Where
141 sitesin 23 countries
Study dates
3 May 2021to 1 Oct 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

141 sites in 23 countries.

141 sites in 23 countries

Japan20 sites

  • Nagoya University Hospital

    Aichi, 466-8560

  • Chiba Cancer Center

    Chiba, 260-8717

  • Toho University Sakura Medical Center

    Chiba, 285-8741

  • Shikoku Cancer Center

    Ehime, 791-0280

  • Fukuyama City Hospital

    Hiroshima, 721-8511

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518

  • National Hospital Organization Hokkaido Cancer Center

    Hokkaido, 003-0804

  • University of Tsukuba Hospital

    Ibaraki, 305-8576

  • St. Marianna University Hospital

    Kanagawa, 216-8511

  • Yokosuka Kyosai Hospital

    Kanagawa, 238-8558

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Nagano Municipal Hospital

    Nagano, 381-8551

  • Iwate Medical University Hospital

    Numakunai, 028-3695

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Saitama Medical University International Medical Center

    Saitama, 350-1298

  • Saitama Cancer Center

    Saitama, 362-0806

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • Keio University Hospital

    Tokyo, 160-8582

  • Toyama University Hospital

    Toyama, 930-0194

Other trials in Japan

Spain14 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic i Provincial

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario Reina Sofia

    Córdoba, Cordoba, 14004

  • Hospital de Donostia

    Donostia / San Sebastian, Guipuzcoa, 20080

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Instituto Valenciano Oncologia

    Valencia, 46009

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

China12 sites

  • Friendship Hospital, Capital Medical University

    Beijing, 100050

  • the First Hospital of Jilin University

    Changchun, 130021

  • Hu Nan Provincial Cancer Hospital

    Changsha, 410006

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, 350005

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • Jiangsu Cancer Hospital

    Nanjing, 210009

  • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

    Nanjing, 210029

  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

    Nanjing, 210029

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

  • Tianjin Cancer Hospital

    Tianjin, 300060

  • Yantai Yu Huangding Hospital

    Yantai, 264099

Other trials in China

Italy12 sites

  • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato

    Arezzo, Tuscany, 52100

  • AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica

    Bologna, Emilia-Romagna, 40138

  • A.O. Universitaria S. Martino Di Genova

    Genoa, Liguria, 16132

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

    Meldola, Emilia-Romagna, 47014

  • Irccs Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milan, Lombardy, 20133

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141

  • Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli", Day Hospital Oncologico

    Naples, Campania, 80131

  • Istituto Nazionale Tumori Irccs Fondazione G. Pascale

    Naples, Campania, 80131

  • A.O. Universitaria S. Luigi Gonzaga

    Orbassano, Piedmont, 10043

  • IOV - Istituto Oncologico Veneto - IRCCS

    Padova, Veneto, 35128

  • Policlinico Universitario "Agostino Gemelli"

    Rome, Lazio, 00168

Other trials in Italy

United Kingdom11 sites

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Barts Hospital

    London, EC1M 6BQ

  • University College London NHS Foundation Trust

    London, NW1 2PG

  • Royal Marsden Hospital - London

    London, SW3 6JJ

  • Charing Cross Hospital

    London, W6 8RF

  • Derriford Hospital

    Plymouth, PL6 8DH

  • Royal Preston Hospital

    Preston, PR2 9HT

  • Weston Park Hospital

    Sheffield, S10 2SJ

  • Southampton University Hospitals NHS Trust

    Southampton, SO16 6YD

  • Royal Marsden Hospital (Sutton)

    Sutton, SM2 5PT

Other trials in United Kingdom

France10 sites

  • ICO Paul Papin

    Angers, 49055

  • Institut Sainte Catherine

    Avignon, 84918

  • Hopital Saint Andre

    Bordeaux, 33075

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Léon Bérard

    Lyon, 69373

  • Centre D'Oncologie de Gentilly

    Nancy, 54100

  • Institut Mutualiste Montsouris

    Paris, 75674

  • Hopital Foch

    Suresnes, 92151

  • Institut Claudius Régaud

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Brazil9 sites

  • *X*Fundação Pio XII Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784-400

  • CETUS Hospital Dia Oncologia

    Belo Horizonte, Minas Gerais, 30110022

  • Oncocentro Serviços Medicos E Hospitalares Ltda

    Fortaleza, Ceará, 60170-170

  • Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-120

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01323-020

Other trials in Brazil

Turkey (Türkiye)8 sites

  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital

    Adana, 01230

  • Ankara University Faculty of Medicine Cebeci Hospital

    Ankara, 06700

  • Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

    Bakirkoy / Istanbul, 34147

  • Medikal Park Izmir Hospital

    Cordaleo, 35575

  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

    Edirne, 22030

  • Istanbul University Cerrahpasa Faculty of Medicine

    Istanbul, 34098

  • Medeniyet University Goztepe Training and Research Hospital.

    Istanbul, 34730

  • Medikal Park Samsun

    Samsun, 55200

Other trials in Turkey (Türkiye)

Germany6 sites

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie

    Halle, 06120

  • Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik

    Herne, 44625

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Universitätsklinikum Ulm

    Ulm, 89081

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

Greece5 sites

  • Attikon University General Hospital

    Ahens, 124 64

  • Alexandras General Hospital of Athens

    Athens, 115 28

  • University Hospital of Larissa

    Larissa, 411 10

  • University Hospital of Patras Medical Oncology

    Pátrai, 265 04

  • Theageneio Hospital

    Thessaloniki, 54007

Other trials in Greece

Ukraine5 sites

  • ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council

    Dnipro, KIEV Governorate, 49005

  • CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR

    Dnipropetrovsk, 49102

  • Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4

    Kharkiv, Kharkiv Governorate, 61037

  • Kyiv City Clinical Oncological Center

    Kyiv, 03115

  • Lviv Regional Clinical Hospital

    Lviv, KIEV Governorate, 79010

Other trials in Ukraine

Poland4 sites

  • PRATIA MCM Kraków

    Krakow, 30-727

  • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu

    Poznan, 60-569

  • Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.

    Warsaw, 04-073

  • Dolnoslaskie Centrum Onkologii

    Wroclaw

Other trials in Poland

Russia4 sites

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040

  • St-Petersburg Regional Oncology Dispensary

    Kuzmolovo, Leningrad, 188663

  • Privolzhsk Regional Medical Center

    Nizhny Novgorod, Niznij Novgorod, 603001

  • FSI Russian Centre of Radiology and Surgical Technologies

    Saint Petersburg, Sankt-Peterburg, 197758

Other trials in Russia

South Korea4 sites

  • National Cancer Center

    Goyang-si, 10408

  • Samsung Medical Center

    Seoul, (0)6351

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

United States3 sites

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • AHN Cancer Institute ? Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Cancer Care Centers of Brevard

    Rockledge, Florida, 32955

Other trials in United States

Colombia3 sites

  • Clinica del Country

    Bogotá, 11001

  • Instituto Cancerología Medellin

    Medellín, 050024

  • Oncomedica S.A.

    Montería, 230002

Other trials in Colombia

Czechia3 sites

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Fakultni nemocnice v Motole

    Prague, 150 06

  • Fakultni Thomayerova nemocnice

    Praha 4 - Krc, 140 59

Other trials in Czechia

Belgium2 sites

  • AZ KLINA

    Brasschaat, 2930

  • UZ Gent

    Ghent, 9000

Other trials in Belgium

Ireland2 sites

  • Cork Uni Hospital

    Cork

  • Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital

    Dublin, D24 NR0A

Other trials in Ireland

Argentina1 site

  • Centro Medico Austral

    Buenos Aires, 1019

Other trials in Argentina

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Israel1 site

  • Tel Aviv Sourasky Medical Ctr

    Tel Aviv, 6423906

Other trials in Israel

Singapore1 site

  • National Cancer Centre

    Singapore, 168583

Other trials in Singapore

About this study

Official title: 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

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.

Being tested
Atezolizumab, Placebo, Signatera

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Tecentriq

    ctDNA positive participants will receive 1680 mg IV, every 4 weeks (Q4W) on Day 1 of each 28-day cycle.

  • PlaceboOther

    ctDNA positive participants will receive placebo IV, Q4W on Day 1 of each 28-day cycle

  • SignateraDevice

    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.

Study groups in NCT04660344
Study groupRoleWhat they receive
Arm A: AtezolizumabExperimentalAtezolizumab 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.
Receives: Drug: Atezolizumab; Device: Signatera
Arm B: PlaceboPlacebo comparatorPlacebo 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.
Receives: Other: Placebo; Device: Signatera
Arm C: Surveillance Follow-UpExperimentalParticipants who remain ctDNA negative at 12 months from the date of cystectomy will not be randomized to treatment and will enter surveillance follow-up.
Receives: Device: Signatera

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. INV-assessed Disease-free Survival (DFS)

    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.

    Measured: From randomization to the first occurrence of a DFS event (Up to 48.2 months)

Secondary outcomes (10)

  1. Overall Survival (OS)

    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.

    Measured: From randomization to death from any cause (Up to 48.2 months)

  2. Independent Review Facility (IRF)-Assessed DFS

    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.

    Measured: From randomization to the first occurrence of a DFS event (Up to 48.2 months)

  3. INV-assessed Disease-specific Survival (DSS)

    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.

    Measured: From randomization to death from UC (Up to 48.2 months)

  4. INV-assessed Distant Metastasis-free Survival (DMFS)

    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.

    Measured: From randomization to the first occurrence of a DMFS event (Up to 48.2 months)

  5. 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)

    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.

    Measured: Up to 11.8 months

  6. Percentage of Participants With ctDNA Clearance

    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.

    Measured: Baseline, Day 1 of Cycles 3 or 5 (Cycle length = 28 days)

  7. Number of Participants With Adverse Events (AEs)

    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.

    Measured: From initiation of study treatment up to approximately 5 years

  8. Maximum Serum Concentration (Cmax) of Atezolizumab

    Measured: 30 minutes post dose on Cycle 1 Day 1 (Cycle length = 28 days)

  9. Minimum Serum Concentration (Cmin) of Atezolizumab

    Measured: Pre-dose on Day 1 of Cycles 2, 3, 4, 8 and 12 (Cycle length = 28 days)

  10. Number of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab

    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.

    Measured: Up to 12.8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2020
  2. Study start3 May 2021
  3. Primary completion15 Jun 2025
  4. Study completion1 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
761 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04660344
Sponsor's protocol ID
BO42843
Other IDs
2020-004418-36, 2022-502705-15-00
Acronym
IMvigor011
Status last verified
Sep 2026
First submitted
1 Dec 2020
Last updated
28 Sep 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 41124204

  • 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.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab and Signatera in people with Muscle-invasive Bladder Cancer, run by Hoffmann-La Roche at 141 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in Japan, Spain, China, Italy, United Kingdom and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

INV-assessed Disease-free Survival (DFS) (time frame: From randomization to the first occurrence of a DFS event (Up to 48.2 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04660344, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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