Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006121

Trial Description

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Title

A Phase II, Multicenter, Single-Arm Study of Atezolizumab (MPDL3280A) in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This phase II, single-arm study was designed to evaluate the effect of Atezolizumab
treatment in patients with locally advanced or metastatic urothelial bladder cancer.
Patients will be enrolled into 1 of 2 cohorts. Cohort 1 will consist of patients who are
treatment-naïve and ineligible for platinum-containing therapy. Cohort 2 will contain
patients who have progressed during or following a prior platinum-based chemotherapy
regimen. Patients in both cohorts will be given a 1200 mg intravenous (IV) dose of
Atezolizumab on Day 1 of 21-day cycles. Treatment of patients in Cohort 1 will continue
until disease progression per RECIST v1.1 criteria or unmanageable toxicity. Treatment of
patients in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity.
Patients will be followed for up for 2 years.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006121
  •   2014/04/28
  •   2014/04/07
  •   no
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Secondary IDs

  •   NCT02108652  (ClinicalTrials.gov)
  •   GO29293  (Hoffmann-La Roche)
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Health Condition or Problem studied

  •   Carcinoma, Transitional Cell , Bladder Cancer, Bladder Tumors, Urinary Bladder Neoplasms
  •   C67 -  Malignant neoplasm of bladder
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Interventions/Observational Groups

  •   Drug: Atezolizumab
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- Objective response rate (ORR); time frame: Up to 3 years

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Secondary Outcome

- Duration of response (DOR); time frame: Up to 3 years
- Progression-free survival (PFS); time frame: Up to 3 years
- Overall survival (OS); time frame: Up to 4 years
- Incidence of adverse events; time frame: Up to 4 years
- Incidence of anti-therapeutic antibodies to MPDL3280A; time frame: Up to 14 months
- Maximum serum concentration (Cmax) of MPDL3280A; time frame: Up to 14 months

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Countries of Recruitment

  •   United States
  •   Canada
  •   France
  •   Germany
  •   Italy
  •   Netherlands
  •   Spain
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2014/05/31
  •   330
  •   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
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 >/= 12 weeks

- Measurable disease, as defined by RECIST v1.1

- Adequate hematologic and end organ function

Cohort 1-Specific Inclusion Criteria

- Ineligible for cisplatin-based chemotherapy due to one of the following:

- Impaired renal function

- A hearing loss of 25 dB at two contiguous frequencies

- Grade 2 or greater peripheral neuropathy

- ECOG performance score of 2

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

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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 CT or
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 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 < 2.5 g/dL

- Positive test for 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-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 .
  •   102
  •   2016/01/14


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