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OpenTrials
Completed

NCT Number: NCT01511913

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

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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Key information

Conditions

Advanced Cutaneous Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution, CABA, Argentina

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events

    Time frame: Every 12 months up to 5 years

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. 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

  3. Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma

    Time frame: Every 12 months up to 5 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Acronym: IMAGE

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Jan 19, 2012
Registry last updated
Dec 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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