Trial document





This trial has been registered retrospectively.
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  DRKS00016925

Trial Description

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Title

Value of FGFR alterations on treatment outcomes in bladder cancer: a multicenter collaboration project

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Trial Acronym

FOsMIC

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URL of the Trial

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Brief Summary in Lay Language

To determine the predictive value of fibroblast growth factor receptor alterations (FGFR2, FGFR3 mutations and fusions) to immunotherapeutic treatment outcomes in patients with advanced urothelial cancer.

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Brief Summary in Scientific Language

To determine the predictive value of FGFR alterations to anti-PD-1 and anti-PD-L1 treatment outcomes in urothelial cancer. Answering the question, how do patients with advanced urothelial cancer and FGFR3 mutations or FGFR2 and FGFR3 gene fusions respond to anti-PD-1 or anti-PD-L1 therapies? Comparison of anti-PD-1 and anti-PD-L1 treatment outcomes in FGFR2/3 alteration-positive versus alteration negative patients.

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Organizational Data

  •   DRKS00016925
  •   2019/04/18
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  •   yes
  •   Approved
  •   2018-829R-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   C67 -  Malignant neoplasm of bladder
  •   C64 -  Malignant neoplasm of kidney, except renal pelvis
  •   C56 -  Malignant neoplasm of ovary
  •   C66 -  Malignant neoplasm of ureter
  •   C68 -  Malignant neoplasm of other and unspecified urinary organs
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Interventions/Observational Groups

  •   Patients with advanced urothelial cancer (bladder or upper urinary tract) who have received anti-PD-(L)1 therapy with at least two months of follow-up. FGFR alterations will be analyzed in tumor material of these patients with advanced urothelial cancer retrospectively.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Tumor recurrance and progression in patients with FGFR-Alterations in advanced urothelial carcinoma after anti-PD-1 or anti-PD-L1 therapies.

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Secondary Outcome

Association of molecular subtype with clinical activity of anti-PD-1 or anti-PD-L1 therapies.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/04/09
  •   120
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Adult patients ≥18 years old.
Patients with histologically confirmed advanced bladder cancer.
Patients who have received anti-PD-(L)1 therapy

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Exclusion Criteria

< 18 years old.

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Addresses

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    • Stratifyer Molecular Pathology
    • Mr.  Dr.  Ralph  Wirtz 
    • Werthmannstraße1
    • 50935  Köln
    • Germany
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    • Stratifyer Molecular Pathology
    • Mr.  Dr.  Ralph  Wirtz 
    • Werthmannstraße 1
    • 50935  Köln
    • Germany
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    • Klinik für Urologie Medizinische Fakultät Mannheim der Universität Heidelberg
    • Mr.  PD Dr.  Philipp  Erben 
    • Theodor-Kutzer-Ufer 1-3
    • 68307  Mannheim
    • Germany
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    • Klinik für Urologie Medizinische Fakultät Mannheim der Universität Heidelberg
    • Mr.  PD Dr.  Philipp  Erben 
    • Theodor-Kutzer-Ufer 1-3
    • 68307  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Janssen Research & Development, LLC
    • 920 U.S. Highway 202
    • 08869  Raritan
    • United States
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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