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This study evaluates the different patterns of care for patients who have unresectable or metastatic melanoma. The dosing, duration, regimen, indication, and treatments will be observed. The survival rate of these patients will also be observed.
Full description
This is a non-interventional, observational study with the primary objective to assess and describe "real world" patterns of care in the treatment of patients with unresectable or metastatic melanoma. A sample size of 1,600 prospective patients will provide sufficient information to explore this primary objective. There will be no forced number of patients enrolled into a specific treatment cohort. Setting or controlling specific treatment enrollment cohort counts would invalidate the results of the primary objective of the study. No primary hypothesis is being tested.
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Inclusion criteria
Prospective cohort patients:
Diagnosis date must occur on or after March 24, 2011 (date of ipilimumab approval in US)
Diagnosis of stage III (unresectable) or stage IV melanoma (includes mucosal, uveal acral-lentiginous, leptomeningeal disease)
Age ≥ 18 years at time of entry into study
Patients must be actively receiving or scheduled to receive systemic treatment (any line, eg, first, second, third line [including investigational drugs]).
Retrospective cohort patients:
Patients with diagnosis of confirmed unresectable stage III or stage IV melanoma (including mucosal, uveal, acral-lentiginous, leptomeningeal disease)
Age ≥ 18 years at time of unresectable or metastatic melanoma diagnosis
Initiated therapy for unresectable or metastatic melanoma within 4 years prior to approval of ipilimumab (first immune checkpoint inhibitor therapy approved in US)
One year of follow-up data is required from date of therapy initiation, if a patient passed away within the one year of follow-up; such patients are still eligible and the date of death will be collected.
Exclusion criteria
Prospective patients:
408 participants in 8 patient groups
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Data sourced from clinicaltrials.gov
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