Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00010315

Trial Description

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Title

A Phase II Single Arm Clinical Trial of Nivolumab (BMS-936558) in Subjects With Metastatic or Unresectable Urothelial Cancer Who Have Progressed or Recurred Following Treatment With a Platinum Agent

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose the study is to measure the effect of nivolumab (BMS-936558) in reducing tumor
size in subjects with metastatic or unresectable bladder cancer.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00010315
  •   2016/04/19
  •   2015/02/26
  •   no
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Secondary IDs

  •   NCT02387996  (ClinicalTrials.gov)
  •   CA209-275  (Bristol-Myers Squibb)
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Health Condition or Problem studied

  •   Various Advanced Cancer
  •   C67 -  Malignant neoplasm of bladder
  •   C66 -  Malignant neoplasm of ureter
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Interventions/Observational Groups

  •   Drug: Nivolumab
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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Primary Outcome

- Objective response rate using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by independent review committee; time frame: Up to 2 years

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Secondary Outcome

- Progression free survival using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in subjects based on assessments by an independent review committee; time frame: Up to 5 years
- Overall survival in subjects as assessed by the investigator; time frame: Up to 5 years
- Objective response rate using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in subjects as assessed by the investigator; time frame: Up to 2 years

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Countries of Recruitment

  •   Australia
  •   Belgium
  •   Czech Republic
  •   Finland
  •   Germany
  •   Italy
  •   Japan
  •   Poland
  •   Spain
  •   Sweden
  •   United States
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Locations of Recruitment

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Recruitment

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  •   2015/03/31
  •   242
  •   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

- Evidence of metastatic or surgically unresectable transitional cell carcinoma of the
urothelium involving the bladder,urethra,ureter or renal pelvis

- Measurable disease by CT or MRI

- Progression or recurrence after treatment

- i) With at least 1 platinum-containing chemotherapy regimen for metastatic or
surgically unresectable locally advanced urothelial cancer, or

- ii) Within 12 months of peri-operative (neo-adjuvant or adjuvant) treatment with a
platinum agent in the setting of cystectomy for localized muscle-invasive urothelial
cancer

- Subject that have received more than 2 prior lines of chemotherapy must not have
liver metastases

- Tumor tissues (archived or new biopsy) must be provided for biomarker analysis

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

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Exclusion Criteria

- Subjects with active cancer that has spread to the central nervous system

- Prior malignancy active within the previous 3 years except for locally curable
cancers that have been apparently cured

- Subject with active, known or suspected autoimmune disease

- Subjects with a condition requiring systemic treatment with either corticosteroids
(>10 mg daily prednisone equivalents) or other immunosuppressive medications within
14 day of study drug administration

- Prior treatment with an anti-PD-1,anti-PD-L1,anti-PD-L2,anti-cytotoxic
T-lymphocyte-associated protein 4 (CTLA-4) antibody, anti-CD137 or any other antibody
or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways

Exclusion laboratory criteria:

- Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus
ribonucleic acid (HCV antibody) indicating acute or chronic infection

- Known history of testing positive for human Immunodeficiency virus (HIV) or known
acquired Immunodeficiency syndrome (AIDS)

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Addresses

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    • Bristol-Myers Squibb
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    • Ono Pharmaceutical Co. Ltd
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    • Bristol-Myers Squibb
    • Bristol-Myers Squibb 
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    • Bristol-Myers Squibb
    • Bristol-Myers Squibb 
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    •   [---]*
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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 .
  •   3
  •   2016/07/17


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