Study in Patients With Unresectable And Metastatic Melanoma: The Optimize Study

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]).

For patients initiating new treatment, treatment must be started within 28 days after signing informed consent.
For patients currently receiving treatment, patients must enroll within the first 21 days of starting new treatment

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)

March 25, 2007 - March 24, 2011

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.

If retrospective patients have at least one year of follow-up data and are then treated with immuno-oncology, immune checkpoint inhibitor therapy, or targeted therapy, these patients will be analyzed separately.

Exclusion Criteria:

Prospective patients:

Patients participating in a clinical study that does not allow enrollment into a non interventional study or clinical studies in which the investigational treatment is blinded
Patients who started new treatment > 21 days
Patients who enrolled in study but did not initiate treatment before 28 days
Patients with current malignancies (except non-melanoma skin cancer and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) that requires additional systemic therapy