We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 2)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02108652
First Posted: April 9, 2014
Last Update Posted: September 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. The results of Cohort 1 are reported separately (NCT02951767). Cohort 2 (reported here) will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity.

Condition Intervention Phase
Bladder Cancer Drug: Atezolizumab Phase 2

An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) ]
    Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% confidence interval (CI) was calculated using the Clopper-Pearson method.

  • Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According Modified RECIST [ Time Frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) ]
    Tumor response was assessed by the investigator according to modified RECIST. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method.


Secondary Outcome Measures:
  • Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1 [ Time Frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) ]
    DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.

  • DOR as Assessed by the Investigator According to RECIST v1.1 [ Time Frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) ]
    DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.

  • DOR as Assessed by the Investigator According to Modified RECIST [ Time Frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) ]
    DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to modified RECIST. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.

  • Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1 [ Time Frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) ]
    Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.

  • Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1 [ Time Frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) ]
    PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

  • Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1 [ Time Frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) ]
    Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.

  • PFS as Assessed by the Investigator According to RECIST v1.1 [ Time Frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) ]
    PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

  • Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to Modified RECIST [ Time Frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) ]
    Tumor response was assessed by the investigator according to modified RECIST. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.

  • PFS as Assessed by the Investigator According to Modified RECIST [ Time Frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) ]
    PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to modified RECIST. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

  • Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According RECIST v1.1 [ Time Frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) ]
    Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method.

  • Percentage of Participants Who Died [ Time Frame: Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) ]
    The percentage of participants who died from any cause was reported.

  • Overall Survival (OS) [ Time Frame: Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) ]
    OS was defined as the time from start of treatment to the time of death from any cause on study.

  • Percentage of Participants Alive at 1-year [ Time Frame: 1-year ]
  • Maximum Serum Concentration (Cmax) of Atezolizumab [ Time Frame: Pre-dose (0 hours) and 30 minutes post-dose on Day 1 of Cycle 1 (Cycle length = 21 days) ]
  • Minimum Serum Concentration (Cmin) of Atezolizumab [ Time Frame: Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (Cycle length = 21 days) ]
  • Percentage of Participants Positive for Anti-therapeutic Antibodies (ATA) to Atezolizumab [ Time Frame: Day 1 of all cycles (Cycle length = 21 days) and at treatment discontinuation (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) ]

Enrollment: 310
Actual Study Start Date: May 31, 2014
Estimated Study Completion Date: May 25, 2018
Primary Completion Date: May 31, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 2: Participants With Second-line or Beyond Treatments
Participants with advanced disease who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting will receive atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
Drug: Atezolizumab
Atezolizumab 1200 mg given by IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria/loss of clinical benefit or unmanageable toxicity.
Other Names:
  • MPDL3280A
  • Tecentriq

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, urethra)
  • Representative tumor specimens as specified by the protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy greater than or equal to (>=) 12 weeks
  • Measurable disease, as defined by RECIST v1.1
  • Adequate hematologic and end organ function

Cohort 2-Specific Inclusion Criteria

  • Disease progression during or following treatment with at least one platinum-containing regimen (e.g., gemcitabine and cisplatin [GC], methotrexate, vinblastine, doxorubicin, and cisplatin [MVAC], CarboGem, etc.) for inoperable locally advanced or metastatic urothelial carcinoma or disease recurrence.
  • A regimen was defined as participants receiving at least two cycles of a platinum-containing regimen. Participants who had received one cycle of a platinum-containing regimen but discontinued due to Grade 4 hematologic toxicity or Grade 3 or 4 non-hematologic toxicity could also be eligible.
  • Participants who received prior adjuvant/neoadjuvant chemotherapy and progressed within 12 months of treatment with a platinum-containing adjuvant/neoadjuvant regimen were considered as second-line participants.

Exclusion Criteria:

  • Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
  • Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
  • Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
  • Leptomeningeal disease
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
  • Uncontrolled hypercalcemia (greater than [>] 1.5 millimoles per liter [mmol/L] ionized calcium or Ca > 12 milligrams per deciliter [mg/dL] or corrected serum calcium > upper limits of normal [ULN]) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
  • Malignancies other than urothelial bladder cancer within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome or incidental prostate cancer
  • Pregnant and lactating women
  • History of autoimmune disease
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • Serum albumin less than (<) 2.5 grams per deciliter (g/dL)
  • Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis
  • Severe infections within 4 weeks prior to Cycle 1, Day 1
  • Significant cardiovascular disease
  • Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1
  • Prior allogeneic stem cell or solid organ transplant
  • Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4), anti-programmed death-1 receptor (anti-PD-1), and anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibodies
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108652


  Hide Study Locations
Locations
United States, Alabama
University of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
Arizona Oncology - HOPE Wilmot
Tucson, Arizona, United States, 85710
United States, California
UCLA
Los Angeles, California, United States, 90024
The Angeles Clinic and Research Institute - W LA Office
Los Angeles, California, United States, 90025
USC Norris Cancer Center
Los Angeles, California, United States, 90033
UCSF
San Francisco, California, United States, 94143-0106
Kaiser Permanente - San Marcos
San Marcos, California, United States, 92069
Stanford Cancer Center
Stanford, California, United States, 94305-5820
Kaiser Permanente; Oncology Clinical Trials
Vallejo, California, United States, 94589
United States, Colorado
Rocky Mountain Cancer Center - Aurora
Aurora, Colorado, United States, 80012
University Of Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Yale Cancer Center ; Medical Oncology
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Georgetown University Medical Center Lombardi Cancer Center
Washington, D.C., District of Columbia, United States, 20057
United States, Florida
Mayo Clinic Cancer Center
Jacksonville, Florida, United States, 32224
United States, Georgia
Piedmont Cancer Institute, PC
Atlanta, Georgia, United States, 30318
United States, Illinois
University of Chicago; Hematology/Oncology
Chicago, Illinois, United States, 60637
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
United States, Indiana
Indiana University Health; Goshen Center for Cancer Care
Goshen, Indiana, United States, 46526
United States, Kentucky
Norton Cancer Institute
Louisville, Kentucky, United States, 40402
United States, Massachusetts
Massachusetts General Hospital;Oncology
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Inst. ; Dept. of Medical Oncology
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center, Harvard Medical School; Department of Medicine
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
Minnesota Oncology Minneapolis
Minneapolis, Minnesota, United States, 55404
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
United States, Nebraska
Urology Cancer Center & GU Research Network
Omaha, Nebraska, United States, 68130
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89128
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12208
NYU Langone Medical Center
New York, New York, United States, 10016
Mount Sinai School of Medicine - Tisch Cancer Institute
New York, New York, United States, 10029
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
Oncology Hematology Care Inc
Cincinnati, Ohio, United States, 45242
Case Western Reserve Univ; Hem/Onc
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
Willamette Valley Cancer Ctr - 520 Country Club
Eugene, Oregon, United States, 97401-8122
United States, Pennsylvania
Kimmel Cancer Center Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
United States, Texas
Ctr for Cancer and Blood Disorders
Fort Worth, Texas, United States, 76104
Texas Oncology - Houston (Gessner)
Houston, Texas, United States, 77024
Houston Methodist Hospital
Houston, Texas, United States, 77030
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Virginia Oncology Associates - Lake Wright Cancer Center
Norfolk, Virginia, United States, 23502
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Canada, British Columbia
Bcca - Cancer Center Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Lakeridge Health Oshawa; Oncology
Oshawa, Ontario, Canada, L1G 2B9
The Ottawa Hospital Cancer Centre; Oncology
Ottawa, Ontario, Canada, K1H 8L6
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, Canada, H3T 1E2
France
APHP - Hospital Saint Louis
Paris, France, 75475
Hopital Foch; Oncologie
Suresnes, France, 92151
Institut Gustave Roussy; Oncologie Medicale
Villejuif, France, 94800
Germany
Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie
Berlin, Germany, 12200
Universitätsklinikum Düsseldorf; Urologische Klinik
Düsseldorf, Germany, 40225
Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie
Freiburg, Germany, 79106
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
Hamburg, Germany, 20246
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
München, Germany, 81675
Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milano, Lombardia, Italy, 20133
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
Arezzo, Toscana, Italy, 52100
Netherlands
The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis
Amsterdam, Netherlands, 1066 CX
Spain
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona, Navarra, Spain, 31008
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, Spain, 08908
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, Spain, 28007
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, Spain, 28034
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, Spain, 28041
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla, Spain, 41013
United Kingdom
University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Barts and The London
London, United Kingdom, EC1M 6BQ
Sarah Cannon Research Institute
London, United Kingdom, W1G 6AD
Royal Marsden Hospital; Dept of Medical Oncology
Sutton, United Kingdom, SM2 5PT
The Clatterbridge Cancer Centre NHS Foundation Trust
Wirral, United Kingdom, L63 4JY
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02108652     History of Changes
Other Study ID Numbers: GO29293 (Cohort 2)
IMvigor 210 ( Other Identifier: Genentech Inc. )
2013-005486-39 ( EudraCT Number )
First Submitted: April 7, 2014
First Posted: April 9, 2014
Results First Submitted: July 1, 2016
Results First Posted: January 4, 2017
Last Update Posted: September 1, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hoffmann-La Roche:
anti-PD-L1
PD-L1
MPDL3280A
PD-1
bladder cancer
atezolizumab
Tecentriq

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs