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TerminatedNCT02450331IMvigor010Updated Jun 18, 2023Results posted

A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection

A Phase 3 interventional study of Atezolizumab in Carcinoma, Transitional Cell, sponsored by Hoffmann-La Roche. Terminated at 186 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-18.

Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment

Why this study was terminated
Sponsor decided to terminate the study early because the study did not meet its primary endpoint and because the study had met its goals of providing safety and additional exploratory efficacy information for atezolizumab monotherapy in MIBC.
Phase
Phase 3
Study type
Interventional
Enrollment
809
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group.

02

Conditions studied

  • Carcinoma, Transitional Cell
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 809 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma) of the bladder or upper urinary tract (i.e., renal pelvis or ureters)
  • For participants treated with prior neoadjuvant chemotherapy: tumor stage of ypT2-4a or ypN+ (ypT2-4 or ypN+ for participants with upper urinary tract UC) and M0
  • For participants who have not received prior neoadjuvant chemotherapy: tumor stage of pT3-4a or pN+ (pT3-4 or pN+ for participants with upper urinary tract UC) and M0
  • Representative formalin-fixed paraffin-embedded tumor specimens from surgical resection (i.e., radical cystectomy, nephroureterectomy, or lymph node dissection) in paraffin blocks (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor programmed death-ligand 1 (PD-L1) expression prior to study enrollment
  • Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging scan of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization
  • Full recovery from cystectomy or nephroureterectomy within 14 weeks following surgery
  • Eastern Cooperative Oncology Group performance status of less than or equal to (\</=) 2
  • Life expectancy greater than or equal to (>/=) 12 weeks
  • Adequate hematologic and end-organ function
  • For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use contraceptive methods that result in a failure rate of less than (\<) 1 percent (%) per year during the treatment period and for at least 5 months after the last dose of atezolizumab

Exclusion criteria

Exclusion Criteria:

  • Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
  • Adjuvant chemotherapy or radiation therapy for UC following surgical resection
  • Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives of the drug prior to enrollment
  • Malignancies other than UC within 5 years prior to Cycle 1, Day 1
  • Pregnancy or breastfeeding
  • Significant cardiovascular disease
  • Severe infections within 4 weeks prior to Cycle 1, Day 1
  • Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1
  • 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
  • Prior allogeneic stem cell or solid organ transplant
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • Positive test for human immunodeficiency virus and/or active hepatitis B or hepatitis C or tuberculosis
  • Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1
  • Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-CD40, anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
809 participants (actual)

Study arms

  • Experimental
    Atezolizumab

    Participants will receive intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).

    Drug: Atezolizumab

  • No intervention
    Observation

    Participants will undergo observation starting on Day 1 for 16 cycles (up to 1 year).

Interventions

  • DrugAtezolizumab

    Atezolizumab will be administered at a dose of 1200 milligrams (mg).

    Also known as: TECENTRIQ®; MPDL3280A

06

What researchers measure

Primary outcomes

  1. Disease-Free Survival (DFS), as Assessed by Investigator

    DFS is defined as the time from randomization to the time of first occurrence of a DFS event. DFS events include: 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. Tumor assessment will be performed using radiographic evaluations.

    Time frame: Randomization up to first occurrence of DFS event (up to approximately 50 months)

Secondary outcomes

  1. Overall Survival (OS)

    Overall survival is defined as the time from randomization to the date of death from any cause, regardless of whether the death occurs during study treatment or following treatment discontinuation.

    Time frame: Randomization until death due to any cause (up to approximately 80 months)

  2. Disease-Specific Survival (DSS), as Assessed by Investigator

    DSS is defined as the time from randomization until the date of death from UC.

    Time frame: Randomization until death due to UC (up to approximately 50 months)

  3. Distant Metastasis-Free Survival (DMFS)

    DMFS is defined as the time from randomization to the date of diagnosis of distant (that is, non-locoregional) metastases or death from any cause. Tumor assessment will be performed using radiographic evaluations.

    Time frame: Randomization up to diagnosis of distant metastases or death from any cause (up to approximately 50 months)

  4. Non-Urinary Tract Recurrence-Free Survival (NURFS)

    NURFS is defined as the time from randomization to the time of first occurrence of a NURFS event. NURFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations.

    Time frame: Randomization up to time of first occurrence of a NURFS event (up to approximately 50 months)

  5. Percentage of Participants With Adverse Events (AEs)

    Percentage of participants with at least one Adverse Event.

    Time frame: Screening up to approximately 80 months

  6. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab

    Percentage of participants with anti-therapeutic antibodies to atezolizumab.

    Time frame: Baseline up to approximately 50 months

  7. EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score

    The EQ-5D-5L is a generic preference-based HRQoL questionnaire that provides a single index value for health status and is used to inform pharmacoeconomic evaluations and to measure general health status. Visual analog scale (VAS) allows the patient to indicate, on a scale of 0-100, how his or her health is on the day of assessment, with 100 being the "best imaginable health state" and 0 being the "worst imaginable health state."

    Time frame: Day 1 of Cycle 1 up to approximately 50 months (Cycle length = 21 days)

  8. Minimum Observed Serum Atezolizumab Concentration (Cmin)

    Minimum observed serum atezolizumab concentration (Cmin) prior to infusion on Day 1 of Cycles 1, 2, 3, and 4; every 8 cycles starting on Cycle 8; at treatment discontinuation; and at 120 days after the last dose of atezolizumab.

    Time frame: Pre-dose (Hour 0) on Day 1 of Cycles 1, 2, 3, 4, every 8 cycles from Cycle 8, at treatment discontinuation, 120 days after treatment discontinuation (up to approximately 50 months))(Cycle length = 21 days)

  9. Maximum Observed Serum Atezolizumab Concentration (Cmax)

    Maximum observed serum atezolizumab concentration (Cmax) after infusion on Day 1 of Cycle 1.

    Time frame: Day 1 of Cycle 1 (Cycle length = 21 days)

07

Results

Posted Nov 18, 2020

Participant flow

Participant flow — Overall Study
MilestoneObservationAtezolizumab
Started403406
Completed171178
Not completed232228
Withdrew: Death162171
Withdrew: Lost to follow-up1412
Withdrew: Withdrawal by subject5544
Withdrew: Non-specified other11

Outcome measures

PrimaryDisease-Free Survival (DFS), as Assessed by Investigator

DFS is defined as the time from randomization to the time of first occurrence of a DFS event. DFS events include: 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. Tumor assessment will be performed using radiographic evaluations.

Time frame:
Randomization up to first occurrence of DFS event (up to approximately 50 months)
Reported as:
Median · Months
Disease-Free Survival (DFS), as Assessed by Investigator
MonthsObservationAtezolizumab
Disease-Free Survival (DFS), as Assessed by Investigator16.6 (11.2 to 24.8)19.4 (15.9 to 24.8)
Statistical analysis
  • Observation vs Atezolizumab · Log Rank · p = 0.2446 · Hazard ratio (hr): 0.892 · 95% CI 0.735 to 1.081
SecondaryOverall Survival (OS)

Overall survival is defined as the time from randomization to the date of death from any cause, regardless of whether the death occurs during study treatment or following treatment discontinuation.

Time frame:
Randomization until death due to any cause (up to approximately 80 months)
Reported as:
Median · Months
Overall Survival (OS)
MonthsObservationAtezolizumab
Overall Survival (OS)59.0 (47.7 to NA)61.4 (47.0 to NA)
Statistical analysis
  • Observation vs Atezolizumab · Log Rank · p = 0.3172 · Hazard ratio (hr): 0.897 · 95% CI 0.726 to 1.109
SecondaryDisease-Specific Survival (DSS), as Assessed by Investigator

DSS is defined as the time from randomization until the date of death from UC.

Time frame:
Randomization until death due to UC (up to approximately 50 months)
Reported as:
Median · Months
Disease-Specific Survival (DSS), as Assessed by Investigator
MonthsObservationAtezolizumab
Disease-Specific Survival (DSS), as Assessed by InvestigatorNA (NA to NA)NA (NA to NA)
Statistical analysis
  • Observation vs Atezolizumab · Log Rank · p = 0.2235 · Hazard ratio (hr): 0.836 · 95% CI 0.626 to 1.116
SecondaryDistant Metastasis-Free Survival (DMFS)

DMFS is defined as the time from randomization to the date of diagnosis of distant (that is, non-locoregional) metastases or death from any cause. Tumor assessment will be performed using radiographic evaluations.

Time frame:
Randomization up to diagnosis of distant metastases or death from any cause (up to approximately 50 months)
Reported as:
Median · Months
Distant Metastasis-Free Survival (DMFS)
MonthsObservationAtezolizumab
Distant Metastasis-Free Survival (DMFS)31.1 (21.7 to 41.4)27.5 (22.6 to NA)
Statistical analysis
  • Observation vs Atezolizumab · Log Rank · p = 0.4291 · Hazard ratio (hr): 0.918 · 95% CI 0.743 to 1.134
SecondaryNon-Urinary Tract Recurrence-Free Survival (NURFS)

NURFS is defined as the time from randomization to the time of first occurrence of a NURFS event. NURFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations.

Time frame:
Randomization up to time of first occurrence of a NURFS event (up to approximately 50 months)
Reported as:
Median · Months
Non-Urinary Tract Recurrence-Free Survival (NURFS)
MonthsObservationAtezolizumab
Non-Urinary Tract Recurrence-Free Survival (NURFS)19.5 (12.3 to 27.7)22.1 (17.2 to 27.6)
Statistical analysis
  • Observation vs Atezolizumab · Log Rank · p = 0.1994 · Hazard ratio (hr): 0.879 · 95% CI 0.722 to 1.070
SecondaryPercentage of Participants With Adverse Events (AEs)

Percentage of participants with at least one Adverse Event.

Time frame:
Screening up to approximately 80 months
Reported as:
Number · Percentage of Participants
Percentage of Participants With Adverse Events (AEs)
Percentage of ParticipantsObservationAtezolizumab
Percentage of Participants With Adverse Events (AEs)79.194.4
SecondaryPercentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab

Percentage of participants with anti-therapeutic antibodies to atezolizumab.

Time frame:
Baseline up to approximately 50 months
Reported as:
Number · Percentage of Participants
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Percentage of ParticipantsAtezolizumab
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab29.3
SecondaryEuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score

The EQ-5D-5L is a generic preference-based HRQoL questionnaire that provides a single index value for health status and is used to inform pharmacoeconomic evaluations and to measure general health status. Visual analog scale (VAS) allows the patient to indicate, on a scale of 0-100, how his or her health is on the day of assessment, with 100 being the "best imaginable health state" and 0 being the "worst imaginable health state."

Time frame:
Day 1 of Cycle 1 up to approximately 50 months (Cycle length = 21 days)
Reported as:
Mean · Score on scale
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score
Score on scaleObservationAtezolizumab
Cycle 1 Day 177.41 ± 15.7478.89 ± 16.13
Cycle 3 Day 178.64 ± 15.7381.05 ± 14.96
Cycle 5 Day 179.94 ± 16.3281.95 ± 14.32
Cycle 7 Day 180.81 ± 16.3782.39 ± 14.43
Cycle 9 Day 181.24 ± 15.7082.06 ± 15.34
Cycle 11 Day 181.39 ± 17.0282.81 ± 14.96
Cycle 13 Day 181.39 ± 16.9982.59 ± 14.81
Cycle 15 Day 182.78 ± 16.0183.67 ± 14.47
Treatment Discontinuation82.68 ± 16.1981.91 ± 15.96
SecondaryMinimum Observed Serum Atezolizumab Concentration (Cmin)

Minimum observed serum atezolizumab concentration (Cmin) prior to infusion on Day 1 of Cycles 1, 2, 3, and 4; every 8 cycles starting on Cycle 8; at treatment discontinuation; and at 120 days after the last dose of atezolizumab.

Time frame:
Pre-dose (Hour 0) on Day 1 of Cycles 1, 2, 3, 4, every 8 cycles from Cycle 8, at treatment discontinuation, 120 days after treatment discontinuation (up to approximately 50 months))(Cycle length = 21 days)
Reported as:
Mean · µg/mL
Minimum Observed Serum Atezolizumab Concentration (Cmin)
µg/mLAtezolizumab
Cycle 2 Day 178.4 ± 25.2
Cycle 3 Day 1125 ± 46.0
Cycle 4 Day 1152 ± 71.1
Cycle 8 Day 1203 ± 92.0
Cycle 16 Day 1225 ± 106
Day 120 Post Last Dose MPDL3280A15.9 ± 19.5
Study Drug or Study Phase Comp or Early Disc164 ± 106
SecondaryMaximum Observed Serum Atezolizumab Concentration (Cmax)

Maximum observed serum atezolizumab concentration (Cmax) after infusion on Day 1 of Cycle 1.

Time frame:
Day 1 of Cycle 1 (Cycle length = 21 days)
Reported as:
Mean · µg/mL
Maximum Observed Serum Atezolizumab Concentration (Cmax)
µg/mLAtezolizumab
Maximum Observed Serum Atezolizumab Concentration (Cmax)365 ± 121

Adverse events

Collected over From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
OBSERVATION162/403 (40.2%)72/398 (18.1%)234/398 (58.8%)
ATEZOLIZUMAB171/406 (42.1%)122/390 (31.3%)324/390 (83.1%)
Most frequent serious events
Showing 10 of 137
Most frequent serious events
EventOBSERVATIONATEZOLIZUMAB
Urinary tract infectionInfections and infestations19/39830/390
PyelonephritisInfections and infestations9/39812/390
PyrexiaGeneral disorders3/39811/390
Acute kidney injuryRenal and urinary disorders4/3988/390
DiarrhoeaGastrointestinal disorders0/3985/390
Pulmonary embolismRespiratory, thoracic and mediastinal disorders5/3981/390
ColitisGastrointestinal disorders0/3984/390
Intestinal obstructionGastrointestinal disorders2/3984/390
PneumoniaInfections and infestations2/3984/390
DeathGeneral disorders1/3983/390
Most frequent other events
Showing 10 of 30
Most frequent other events
EventOBSERVATIONATEZOLIZUMAB
PruritusSkin and subcutaneous tissue disorders10/39892/390
FatigueGeneral disorders43/39889/390
DiarrhoeaGastrointestinal disorders25/39881/390
PyrexiaGeneral disorders30/39871/390
Urinary tract infectionInfections and infestations59/39863/390
ArthralgiaMusculoskeletal and connective tissue disorders26/39853/390
NauseaGastrointestinal disorders20/39852/390
ConstipationGastrointestinal disorders39/39851/390
CoughRespiratory, thoracic and mediastinal disorders23/39847/390
Decreased appetiteMetabolism and nutrition disorders20/39845/390

Baseline characteristics

Age, Continuous
Age, Continuous(Years)ObservationAtezolizumabTotal
Mean65.9 ± 9.366.0 ± 9.065.9 ± 9.1
Sex: Female, Male
Sex: Female, Male(Participants)ObservationAtezolizumabTotal
Female8784171
Male316322638
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)ObservationAtezolizumabTotal
Hispanic or Latino91625
Not Hispanic or Latino357369726
Unknown or Not Reported372158
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Number of Participants)ObservationAtezolizumabTotal
American Indian or Alaska Native011
Asian6864132
Black or African American336
White307320627
Other4610
Unknown211233
08

Study locations

186 sites
  • HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network
    Scottsdale, Arizona 85258, United States
  • UCLA
    Los Angeles, California 90024, United States
  • USC Norris Cancer Center
    Los Angeles, California 90033, United States
  • Stanford University Medical Center
    Palo Alto, California 94304, United States
  • University Of Colorado
    Aurora, Colorado 80045, United States
  • The Urology Center of Colorado
    Denver, Colorado 80211, United States
  • Yale Cancer Center; Medical Oncology
    New Haven, Connecticut 06520, United States
  • Northwestern University Feinberg School Of Medicine
    Chicago, Illinois 60611, United States
  • University of Chicago; Hematology/Oncology
    Chicago, Illinois 60637, United States
  • University of Iowa Hospital & Clinic; Division of Hematology/Oncology
    Iowa City, Iowa 52242, United States
  • Albert B. Chandler Medical Center; University of Kentucky
    Lexington, Kentucky 40536, United States
  • Norton Cancer Institute
    Louisville, Kentucky 40202, United States
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
    Baltimore, Maryland 21287, United States
  • Chesapeake Urology Research Associates
    Towson, Maryland 21204, United States
  • Dana Farber Cancer Inst.
    Boston, Massachusetts 02115, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Massachusetts General Hospital.
    Boston, Massachusetts 2114, United States
  • University Of Michigan
    Ann Arbor, Michigan 48109, United States
  • Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
  • Henry Ford Health System
    Detroit, Michigan 48202, United States
  • MSK @Basking Ridge
    Basking Ridge, New Jersey 07920, United States
  • Saint Barnabas Medical Center Cancer Center
    Livingston, New Jersey 07039, United States
  • Memorial Sloan-Kettering Cancer Center
    Commack, New York 11725, United States
  • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
    New York, New York 10016, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • Levine Cancer Institute
    Charlotte, North Carolina 28204, United States
  • Duke Cancer Center
    Durham, North Carolina 27710, United States
  • Wake Forest University Baptist Medical Center
    Winston-Salem, North Carolina 27157, United States
  • Cleveland Clinic
    Cleveland, Ohio 44106, United States
  • Fairview Hospital; Cleveland Clinic Cancer Center
    Cleveland, Ohio 44111, United States
  • The Ohio State University Wexner Medical Center
    Columbus, Ohio 43212, United States
  • Cleveland CL N Coast Cancer Cr
    Sandusky, Ohio 44870, United States
  • Abramson Cancer Center; Univ of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Kimmel Cancer Center Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
  • Fox Chase-Temple Cancer Center
    Philadelphia, Pennsylvania 19111, United States
  • Miriam Hospital
    Providence, Rhode Island 02906, United States
  • University of Texas Southwestern
    Dallas, Texas 75390-8897, United States
  • Baylor College of Medicine; Gastroenterology
    Houston, Texas 77030, United States
  • University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78229, United States
  • University of Virginia
    Charlottesville, Virginia 22906, United States
  • Seattle Cancer Care Alliance
    Seattle, Washington 98109, United States
  • Macquarie University Hospital
    Macquarie Park, New South Wales 2109, Australia
  • Royal Brisbane & Women's Hosp; Cancer Care Serv
    Herston, Queensland 4029, Australia
  • Monash Medical Centre; Oncology
    Clayton, Victoria 3168, Australia
  • Austin and Repatriation Medical Centre; Cancer Services
    Melbourne, Victoria 3084, Australia
  • Institut Jules Bordet
    Anderlecht, 1070, Belgium
  • Cliniques Universitaires St-Luc
    Bruxelles, 1200, Belgium
  • UZ Gent
    Gent, 9000, Belgium
  • UZ Leuven Gasthuisberg
    Leuven, 3000, Belgium
  • Cross Cancer Institute ; Dept of Medical Oncology
    Edmonton, Alberta T6G 1Z2, Canada
  • BCCA-Vancouver Cancer Centre
    Vancouver, British Columbia V5Z 4E6, Canada
  • Royal Victoria Hospital
    Barrie, Ontario L4M 6M2, Canada
  • London Regional Cancer Centre
    London, Ontario N6A 4L6, Canada
  • Lakeridge Health Oshawa; Oncology
    Oshawa, Ontario L1G 2B9, Canada
  • The Ottawa Hospital Cancer Centre; Oncology
    Ottawa, Ontario K1H 8L6, Canada
  • North York General Hospital
    Toronto, Ontario M2J 1V1, Canada
  • Sunnybrook Odette Cancer Centre
    Toronto, Ontario M4N 3M5, Canada
  • McGill University; Glen Site; Oncology
    Montreal, Quebec H4A 3J1, Canada
  • CHU de Quebec Hotel-Dieu de Quebec
    Quebec City, Quebec G1R 2J6, Canada
  • Peking University First Hospital
    Beijing City, 100034, China
  • Friendship Hospital, Capital Medical University
    Beijing, 100050, China
  • Beijing Cancer Hospital
    Beijing, 100142, China
  • The Second Affiliated Hospital, Sun Yat-sen University
    Guangzhou City, 510120, China
  • Jiangsu Cancer Hospital
    Nanjing City, 211100, China
  • Jiangsu Province Hospital
    Nanjing, 210008, China
  • Huashan Hospital Affiliated to Fudan University
    Shanghai City, 200040, China
  • Fudan University Shanghai Cancer Center
    Shanghai City, 200120, China
  • Zhongshan Hospital Fudan University
    Shanghai, 200032, China
  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    Shanghai, 200092, China
  • Masarykuv onkologicky ustav
    Brno, 656 53, Czechia
  • Fakultni nemocnice Olomouc; Onkologicka klinika
    Olomouc, 779 00, Czechia
  • Multiscan s.r.o.
    Pardubice, 532 03, Czechia
  • University Hospital Motol; Department of Urology
    Praha 5, 15006, Czechia
  • Helsinki University Central Hospital; Urology Clinics
    Helsinki, 00029, Finland
  • Tampere University Hospital; Dept Of Urology
    Tampere, 33520, Finland
  • Turku University Central Hospital; Urology clinic
    Turku, 20520, Finland
  • ICO Paul Papin; Oncologie Medicale.
    Angers, 49055, France
  • Institut Sainte Catherine;Recherche Clinique
    Avignon, 84918, France
  • Hopital Saint Andre
    Bordeaux, 33075, France
  • Centre Francois Baclesse; Recherche Clinique
    Caen, 14076, France
  • Centre Jean Perrin
    Clermont Ferrand, 63011, France
  • Centre Leon Berard; Departement Oncologie Medicale
    Lyon, 69373, France
  • Centre D'Oncologie de Gentilly; Oncology
    Nancy, 54100, France
  • Centre Antoine Lacassagne
    Nice, 06189, France
  • Hopital Cochin; Unite Fonctionnelle D Oncologie
    Paris, 75014, France
  • Hopital Saint Louis; Oncologie Medicale
    Paris, 75475, France
  • Institut Mutualiste Montsouris; Oncologie
    Paris, 75674, France
  • Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
    Paris, 75908, France
  • ICO - Site René Gauducheau
    Saint Herblain, 44805, France
  • Institut Claudius Regaud; Departement Oncologie Medicale
    Toulouse, 31059, France
  • Campus Charitè Mitte Charité Centrum 10. Klinik f.Urologie
    Berlin, 10117, Germany
  • Augusta-Kranken-Anstalt gGmbH; Klinik für Hämatologie, Onkologie & Palliativmedizin
    Bochum, 44791, Germany
  • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
    Dresden, 01307, Germany
  • Universitätsklinikum Düsseldorf; Urologische Klinik
    Düsseldorf, 40225, Germany
  • Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik
    Herne, 44625, Germany
  • Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie
    Mannheim, 68167, Germany
  • Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
    München, 81675, Germany
  • Universitätsmedizin Rostock, Urologische Klinik und Poliklinik
    Rostock, 18057, Germany
  • Diakonie-Klinikum Stuttgart; Urologische Klinik
    Stuttgart, 70176, Germany
  • Universitätsklinikum Tübingen; Klinik für Urologie
    Tübingen, 72076, Germany

Showing the first 100 of 186 sites across 24 countries.

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References and documents

Publications

  • Bellmunt J, Hussain M, Gschwend JE, Albers P, Oudard S, Castellano D, Daneshmand S, Nishiyama H, Majchrowicz M, Degaonkar V, Shi Y, Mariathasan S, Grivas P, Drakaki A, O'Donnell PH, Rosenberg JE, Geynisman DM, Petrylak DP, Hoffman-Censits J, Bedke J, Kalebasty AR, Zakharia Y, van der Heijden MS, Sternberg CN, Davarpanah NN, Powles T; IMvigor010 Study Group. Adjuvant atezolizumab versus observation in muscle-invasive urothelial carcinoma (IMvigor010): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):525-537. doi: 10.1016/S1470-2045(21)00004-8. Epub 2021 Mar 12. PubMed 33721560 ↗

Study documents

  • Study protocol · Apr 13, 2020
  • Statistical analysis plan · Feb 1, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02450331
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
May 21, 2015
Start date
Oct 5, 2015
Primary completion
Nov 30, 2019
Completion
Jun 14, 2022
Results posted
Nov 18, 2020
Last update
Jun 18, 2023

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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