Trial record 1 of 1 for:    NCT01511913
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A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma (IMAGE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01511913
First received: November 15, 2011
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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.


Condition
Cutaneous Melanoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events [ Time Frame: Every 12 months up to 5 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Patterns of disease monitoring as observed in a real-world setting [ Time Frame: Every 12 months up to 5 years ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Resource utilization associated with advanced melanoma treatment [ Time Frame: Every 12 months up to 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1800
Study Start Date: April 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ipilimumab treated cohort of 1000 patients
All patients identified and followed prospectively
Non-Ipilimumab treated cohort of 800 patients
600 patients will be identified and followed prospectively, and 200 patients retrospectively identified and followed

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Eligible patients will be selected from approximately 200 medical practice sites (e.g. community-based, office-based, hospital-based, academic setting) in several European Union countries, Central America, North America, and South America, as well as Australia and Israel.

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Diagnosis of unresectable or metastatic melanoma
  • Age of 18 years or older at time of entry into the study
  • 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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511913

Contacts
Contact: For participation information at a USA site use a phone number below. For Site information outside USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time

  Show 183 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01511913     History of Changes
Other Study ID Numbers: CA184-143, ENCEPP/SDPP/2723
Study First Received: November 15, 2011
Last Updated: August 19, 2014
Health Authority: European Union: European Medicines Agency

Keywords provided by Bristol-Myers Squibb:
Unresectable or metastatic cutaneous melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 16, 2014