Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004786

Trial Description

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Title

A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma

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Trial Acronym

IMAGE

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to examine the safety of Ipilimumab and patterns of use in the
treatment of unresectable or metastatic melanoma in the post-approval setting.

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Brief Summary in Scientific Language

Time Perspective: this study does have a retrospective component involving a subset of
patients.

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Organizational Data

  •   DRKS00004786
  •   2013/05/13
  •   2011/11/15
  •   no
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Secondary IDs

  •   NCT01511913  (ClinicalTrials.gov)
  •   CA184-143  (Bristol-Myers Squibb)
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Health Condition or Problem studied

  •   Cutaneous Melanoma
  •   C43 -  Malignant melanoma of skin
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Incidence and severity of adverse reactions in patients treated with Ipilimumab in the post-approval setting; time frame: Every 12 months up to 5 years
- Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events; time frame: Every 12 months up to 5 years
- Frequency at which immunosuppressive therapy was administered to patients to manage treatment-related adverse events associated with Ipilimumab; time frame: Every 12 months up to 5 years
- Patterns of disease monitoring as observed in a real-world setting; time frame: Every 12 months up to 5 years; To evaluate patterns of care, descriptive statistics will describe treatment, dosing, regimen, indication, treatment rationales, management of treatment-related adverse events, reasons for treatment termination

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Secondary Outcome

- Quality of life (QoL), impact on work productivity, and overall satisfaction among patients receiving any therapy for unresectable or metastatic melanoma; time frame: Every 12 months up to 5 years
- Resource utilization associated with advanced melanoma treatment; time frame: Every 12 months up to 5 years; Descriptive statistics will be reported for healthcare utilization (inpatient, outpatient, emergency department and other ancillary services) and imputed costs
- Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma; time frame: Every 12 months up to 5 years

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Australia
  •   Austria
  •   Brazil
  •   Canada
  •   France
  •   Germany
  •   Ireland
  •   Israel
  •   Mexico
  •   Poland
  •   Spain
  •   Switzerland
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2012/04/30
  •   1800
  •   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

- Diagnosis of unresectable or metastatic melanoma

- Age of 18 years or older at time of entry into the study

- Received at least one prior therapy for unresectable or metastatic melanoma

- Patients who have initiated treatment for unresectable or metastatic melanoma at
medical practice (e.g. community-based, office-based, hospital-based, academic
setting)within 21 days before informed consent for this study OR in the case where
treatment has not yet been initiated, documentation that the treatment strategy was
determined before informed consent for this study, and treatment must be initiated
within 28 days after informed consent.

- Ipilimumab-treated patients must be receiving treatment for the indication(s)
approved in their country of residence or where they are receiving treatment

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Exclusion Criteria

- Current or pending participation in a clinical trial examining therapy for the
treatment of any cancer (including unresectable or metastatic melanoma)

- Current use of therapy to treat a primary cancer other than melanoma

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Addresses

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    • Bristol-Myers Squibb
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    • Bristol-Myers Squibb
    • Bristol-Myers Squibb 
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    • For participation information at a USA site use a phone number below. For Site information outside USA please email: 
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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 ongoing
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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 .
  •   101
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.