Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007603

Trial Description

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Title

A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) COMPARED WITH CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL BLADDER CANCER AFTER FAILURE WITH PLATINUM-CONTAINING CHEMOTHERAPY [IMvigor211]

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study
designed to evaluate the efficacy and safety of Atezolizumab compared with chemotherapy in
patients with locally advanced or metastatic urothelial bladder cancer (UBC) who have
progressed during or following a platinum-containing regimen. The anticipated time on study
treatment is based on continued clinical benefit, i.e., until disease progression or
unacceptable toxicity. The target sample size is 767 patients. [IMvigor211]

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007603
  •   2015/02/19
  •   2014/11/25
  •   no
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Secondary IDs

  •   2014-003231-19 
  •   NCT02302807  (ClinicalTrials.gov)
  •   GO29294  (Hoffmann-La Roche)
  •   2014-003231-19 
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Health Condition or Problem studied

  •   Bladder Cancer
  •   C67 -  Malignant neoplasm of bladder
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Interventions/Observational Groups

  •   Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
  •   Drug: Chemotherapy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Overall survival; time frame: Between randomization and death due to any cause, up to approximately 23 months after first patient enrolled

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Secondary Outcome

- Objective response rate (ORR); time frame: Up to approximately 23 months after first patient enrolled
- Progression-free survival (PFS); time frame: Up to approximately 23 months after first patient enrolled
- Duration of response (DOR); time frame: Up to approximately 23 months after first patient enrolled
- Incidence of adverse events (AEs); time frame: Up to approximately 23 months after first patient enrolled
- Incidence of anti-therapeutic antibodies to Atezolizumab; time frame: Up to approximately 23 months after first patient enrolled
- Maximum serum concentration (Cmax) of Atezolizumab; time frame: Up to approximately 23 months after first patient enrolled

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Countries of Recruitment

  •   United States
  •   Australia
  •   Austria
  •   Belgium
  •   Canada
  •   Czech Republic
  •   Denmark
  •   Finland
  •   France
  •   Germany
  •   Greece
  •   Hungary
  •   Italy
  •   Japan
  •   Korea, Republic of
  •   Netherlands
  •   Norway
  •   Poland
  •   Portugal
  •   Romania
  •   Russian Federation
  •   Serbia
  •   Slovenia
  •   Spain
  •   Sweden
  •   Switzerland
  •   Taiwan, Province of China
  •   Turkey
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2015/01/31
  •   767
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Age >/= 18 years

- Histologically or cytologically documented locally advanced or metastatic UBC
(including renal pelvis, ureters, urinary bladder, and urethra)

- Representative tumor specimens as specified by the protocol

- Disease progression during or following treatment with at least one
platinum-containing regimen for inoperable, locally advanced or metastatic UBC or
disease recurrence

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Life expectancy >/= 12 weeks

- Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors
(RECIST) v1.1

- Adequate hematologic and end organ function

- For female patients of childbearing potential and male patients with partners of
childbearing potential, agreement (by patient and/or partner) to use highly effective
form(s) of contraception as defined by the protocol and to continue its use for 6
months after the last dose of MPDL3280A

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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

- Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the
exception of those with a negligible risk of metastasis or death and treated with
expected curative outcome, or localized prostate cancer treated with curative intent
and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer

- Pregnant and lactating women

- Significant cardiovascular disease

- Severe infections within 4 weeks prior to randomization

- Major surgical procedure other than for diagnosis within 4 weeks prior to
randomization

- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins; known hypersensitivity or
allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any
component of the MPDL3280A 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 HIV and/or active hepatitis B or hepatitis C or tuberculosis

- Administration of a live, attenuated vaccine within 4 weeks prior to randomization

- Prior treatment with CD137 agonists or immune checkpoint blockade therapies,
including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies

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Addresses

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    • Hoffmann-La Roche
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    • Hoffmann-La Roche
    • Clinical Trials 
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    • Hoffmann-La Roche
    • Clinical Trials 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   24
  •   2016/04/10


* This entry means the parameter is not applicable or has not been set.