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

• ClinicalTrials.gov Identifier: NCT01511913
• Recruitment Status: Unknown
• First Posted: January 19, 2012
• Last Update Posted: December 31, 2018
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: November 15, 2011
• First Posted Date: January 19, 2012
• Last Update Posted Date: December 31, 2018
• Actual Study Start Date: April 30, 2012
• Estimated Primary Completion Date: May 11, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 18, 2012)

• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 18, 2012)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma
• Official Title: A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma
• Brief Summary: 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.
• Detailed Description: Time Perspective: this study does have a retrospective component involving a subset of patients.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Advanced Cutaneous Melanoma

Intervention

Other: Non-Interventional

Non-Interventional

Study Groups/Cohorts

• Ipilimumab treated cohort of 1000 patients
  All patients identified and followed prospectively
  Intervention: Other: Non-Interventional
• Non-Ipilimumab treated cohort of 800 patients
  600 patients will be identified and followed prospectively, and 200 patients retrospectively identified and followed
  Intervention: Other: Non-Interventional

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 18, 2012): 1800
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 28, 2020
• Estimated Primary Completion Date: May 11, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Austria, Belgium, Canada, France, Germany, Greece, Ireland, Israel, Poland, Spain, Switzerland, United Kingdom, United States
• Removed Location Countries: Brazil, Mexico

Administrative Information

• NCT Number: NCT01511913
• Other Study ID Numbers: CA184-143; ENCEPP/SDPP/2723 ( Other Identifier: Euro. Ntwk. of Ctrs. for Pharmacoepidemiology and Pharmacovigilance )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Bristol-Myers Squibb
• Study Sponsor: Bristol-Myers Squibb
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: December 2018