Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States

Study Overview
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Brief Summary
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This study will collect real-world data from advanced melanoma diagnosis through most recent visit and data sourced from patient medical records following a 2-part study design consisting of a random sample (Part 1) and an oversample (Part 2).

Official Title
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Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States

Conditions
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Melanoma

Intervention / Treatment
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* Other: Non-Interventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18 years or older Diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma before 01-Nov-2015 Initiating a new line of therapy during the index period between 01-Jan-2015 and 31-May-2016, irrespective of advanced melanoma diagnosis date Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period) Exclusion Criteria: Physicians unwilling or unable to follow study instructions Patients who were previously enrolled in a cancer treatment-related clinical trial since the diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma

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 |
| --- | --- |
| advanced melanoma patients<br>Part 1 will consist of a representative sample of advanced melanoma patients, irrespective of date of diagnosis of stage III unresectable and metastatic/stage IV, to address information objectives on treatment patterns, clinical outcomes, and resource use after the start of treatment post-launch of new drugs, ie, since 2011 for ipi and 2015 for ipi + nivo in advanced melanoma | Other: Non-Interventional<br>* Non-Interventional<br>|
| Ipi monotherapy<br>Part 2: patients must have been prescribed Ipi monotherapy during the index period between 01-Jan-2015 and 31-May-2016. | Other: Non-Interventional<br>* Non-Interventional<br>|
| Ipi + nivo combination therapy<br>Part 2: patients must have been prescribed Ipi + nivo combination therapy during the index period between 01-Jan-2015 and 31-May-2016. | Other: Non-Interventional<br>* Non-Interventional<br>|
| Dabrafenib + trametinib combination therapy<br>Part 2: patients must have been prescribed Dabrafenib + trametinib combination therapy during the index period between 01-Jan-2015 and 31-May-2016. | Other: Non-Interventional<br>* Non-Interventional<br>|
| Pembro monotherapy<br>Part 2: patients must have been prescribed Pembro monotherapy during the index period between 01-Jan-2015 and 31-May-2016 | Other: Non-Interventional<br>* Non-Interventional<br>|
| Nivo monotherapy<br>Part 2: patients must have been prescribed Nivo monotherapy during the index period between 01-Jan-2015 and 31-May-2016 | Other: Non-Interventional<br>* Non-Interventional<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of treatment patterns for advanced melanoma patients | Distribution of treatment patterns for advanced melanoma patients including, treatment regimen selection and rationale, as well as time to initiation of therapy and type of therapy | Aproximately 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of prescribing patterns | Distribution of prescribing patterns by type of practice setting and melanoma patient volume | Approximately 16 months | 
| Distribution of Patient Age at index date | Patient Age at index date will be determined from Medical Records | at baseline | 
| Distribution of Patient's Sex at Index Date | Patient's sex will be determined from Medical Records | At Baseline | 
| Distribution of Comorbidities at index date | Comorbidities will be determined using the Charlson Comorbidity Index (CCI) | At Baseline | 
| Distribution of Healthcare Coverage type | Healthcare Coverage type will be determined using Medical Records | At Baseline | 
| Distribution of Diagnosis Date | Melanoma Diagnosis Date will be determined using medical records | At Baseline | 
| Distribution of Advanced Diagnosis Date | Date of advanced/ metastatic melanoma diagnosis will be determined using medical records | At Baseline | 
| Distribution of Age at Onset | Diagnosis date-Date of Birth | At Baseline | 
| Distribution of Disease stage at time of diagnosis | Disease stage at time of diagnosis will be determined using medical records | At Baseline | 
| Distribution of Disease stage at subsequent visits | Disease stage at subsequent visits will be determined using medical records | Approximately 16 months | 
| Distribution of ECOG status at Baseline | Eastern Cooperative Oncology Group (ECOG) status at Baseline will be determined using medical records | At Baseline | 
| Distribution of ECOG status at Last Visit | Eastern Cooperative Oncology Group (ECOG) status at Last Visit will be determined using medical records | Approximately 16 months | 
| Distribution of Biomarker status at baseline | Biomarker status will be determined using Medical Records | at baseline | 
| Distribution of treatment-related adverse events | treatment-related adverse events will be determined using medical records | Approximately 16 months | 
| Distribution of Overall Survival (OS) from Advanced Diagnosis | Date of death minus advanced/metastatic diagnosis date, censoring for LTF or end of observation | Approximately 16 months | 
| Distribution of Progression-Free Survival (PFS) at Advanced Diagnosis | Date of progression (increase in tumor size or increase in cancer stage)/start of next line of therapy minus advanced/metastatic diagnosis date, censoring for LTF or end of observation | Approximately 16 months | 
| Distribution of Overall Response Rate (ORR) |  | Approximately 16 months | 
| Distribution of Overall Survival (OS) from Index Date | Date of death minus index treatment start date, censoring for LTF or end of observation | Approximately 16 months | 
| Distribution of Progression-Free Survival (PFS) at Index Date | Date of progression (increase in tumor size or increase in cancer stage)/start of next line of therapy minus index treatment start date, censoring for LTF or end of observation | Approximately 16 months | 
| Distribution of melanoma related HCRU |  | Approximately 16 months |