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

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.

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.

1. 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