A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma (IMAGE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01511913 |
Recruitment Status : Unknown
Verified December 2018 by Bristol-Myers Squibb.
Recruitment status was: Active, not recruiting
First Posted : January 19, 2012
Last Update Posted : December 31, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Advanced Cutaneous Melanoma | Other: Non-Interventional |
Study Type : | Observational |
Estimated Enrollment : | 1800 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma |
Actual Study Start Date : | April 30, 2012 |
Estimated Primary Completion Date : | May 11, 2020 |
Estimated Study Completion Date : | November 28, 2020 |

Group/Cohort | Intervention/treatment |
---|---|
Ipilimumab treated cohort of 1000 patients
All patients identified and followed prospectively
|
Other: Non-Interventional
Non-Interventional |
Non-Ipilimumab treated cohort of 800 patients
600 patients will be identified and followed prospectively, and 200 patients retrospectively identified and followed
|
Other: Non-Interventional
Non-Interventional |
- 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
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511913

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT01511913 |
Other Study ID Numbers: |
CA184-143 ENCEPP/SDPP/2723 ( Other Identifier: Euro. Ntwk. of Ctrs. for Pharmacoepidemiology and Pharmacovigilance ) |
First Posted: | January 19, 2012 Key Record Dates |
Last Update Posted: | December 31, 2018 |
Last Verified: | December 2018 |
Unresectable or metastatic cutaneous melanoma |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |