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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A US Multi-Site Observational Study in Patients With Unresectable And Metastatic Melanoma: The OPTIMIzE Study

Conditions
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Melanoma

Participation Criteria
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Eligibility Criteria
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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]). 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective Patients<br>There will be 1,600 prospective patients recruited over a period of two years and followed-up for a planned minimum of three years. For the prospective cohort, patients will be recruited after the course of treatment has been decided by the physician and prior to the start of treatment.Prior advanced melanoma treatment information will be collected from patient charts for pre-treated patients. Patients will be followed for a minimum of 3 years from their study index date until death, withdrawal of consent, lost to follow-up/record, or end of study, whichever comes first. Study index date will be the date when first study therapy is initiated. | |
| Treatment Group No. 1<br>Immune checkpoint inhibitor patients who remain on an immune checkpoint inhibitor therapy. Defined as immune checkpoint inhibitor therapy patients who either remained on their initial (index) immune checkpoint inhibitor therapy or switched to another immune checkpoint inhibitor therapy during the study period. Patients in this group remained on an immune checkpoint inhibitor therapy and did not switch to a non-immune checkpoint inhibitor therapy anytime during the study period. | |
| Treatment Group No. 2<br>Immune checkpoint inhibitor patients who switched to a non-immune checkpoint inhibitor therapy. Defined as patients who switched from their index immune checkpoint inhibitor therapy to a non-immune checkpoint inhibitor therapy anytime during the study period. | |
| Treatment Group No. 3<br>Targeted therapy patients who remain on a targeted therapy. Defined as targeted therapy patients who either remained on their initial (index) targeted therapy or switched to another targeted therapy during the study period. Patients in this group remained on a targeted therapy and did not switch to a non-targeted therapy anytime during the study period. | |
| Treatment Group No. 4<br>Targeted therapy patients who switched to a non-targeted therapy. Defined as patients who switched from their index targeted therapy to a non-targeted therapy anytime during the study period. | |
| Treatment Group No. 5<br>Chemotherapy/other therapy patients who remain on a chemotherapy/other therapy. Defined as chemotherapy/other therapy patients who either remained on their initial (index) chemotherapy/other therapy or switched to another chemotherapy/other therapy during the study period. Patients in this group remained on a chemotherapy/other therapy and did not switch to an immune checkpoint inhibitor therapy or targeted therapy anytime during the study period. | |
| Treatment Group No. 6<br>Chemotherapy/other patients who switched to an immune checkpoint inhibitor therapy or targeted therapy. Defined as patients who switched from their index chemotherapy/other therapy to an immune checkpoint inhibitor therapy or targeted therapy anytime during the study period. | |
| Retrospective Patients<br>Retrospective cohort of 600 patients with unresectable or metastatic melanoma, receiving therapies other than immune checkpoint inhibitor or targeted therapies during the four year period prior to the release of ipilimumab (March 25, 2007 -March 24, 2011), will be identified. The data for these 600 retrospective patients will be used as a benchmark for treatment patterns and outcomes prior to the marketed availability of immune checkpoint inhibitors or targeted therapies. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patterns of Care | To assess the selection and sequencing of drugs and practice patterns used to treat unresectable and metastatic melanoma (e.g. immune checkpoint agents, targeted agents, or combination therapies) in a real-world setting. Reasons for initial treatment decisions across and between drug classes, changes in treatment, and discontinuation will be recorded (e.g. lack of benefit, safety, cost, or other barriers to care). | Up to 5 years | 
| Demographics | Baseline characteristics (age, gender, race/ethnicity) | Up to 5 years | 
| Overall Survival | To estimate overall survival in patients receiving therapy for unresectable or metastatic melanoma some statistical measurements and actual survival will be used. | Up to 5 years | 
| Disease Characteristics | Disease characteristics (date of diagnosis, disease stage, performance status) | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare Resource | To compare and describe healthcare utilization, imputed costs, and impact of initial treatment choice on lifetime or periodic costs. Due to potential differences between in patterns of care among various regions, region-specific analyses may be conducted for healthcare resource utilization. | up to 5 years | 
| Functional Assessments of Cancer Therapy-Melanoma (FACT-M) |  | Up to 12 months | 
| European Quality of Life-5 Dimensions (EQ-5D) |  | Up to 12 months | 
| Work Productivity and Activity Impairment: General Health (WPAI:GH) |  | Up to 12 months | 
| The Caregiver Quality of Life Index - Cancer (CQOLC) |  | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic, Unresectable