Study of First-line Treatment Patterns and Clinical Outcomes in Patients With Advanced Melanoma in the United Kingdom

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the first-line therapy landscape for patients with advanced melanoma and to describe clinical outcomes and healthcare resource utilization in a subset of treatment-naïve patients who initiated nivolumab + ipilimumab combination therapy.

Official Title
-----------------
Retrospective Chart Review Study of First-line Treatment Patterns and Clinical Outcomes in Patients With Advanced (Unresectable or Metastatic) Melanoma in the United Kingdom

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Other: Non-interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Patient has medical chart documentation of advanced (unresectable or metastatic) melanoma. Patient initiated a first-line therapy for the treatment of advanced melanoma during the eligibility period (01 July 2016 to 01 July 2017; index event). Patient did not receive systemic treatment for their advanced (unresectable or metastatic) melanoma prior to index event Patient initiated first-line therapy at least six months before the date their chart abstraction initiated Exclusion Criteria: Patient was enrolled in an investigational drug clinical trial or participating in medical research judged to directly affect how the patient was being monitored/treated while receiving first-line therapy Patient had another active concurrent malignancy other than advanced melanoma, which required systemic treatment at the time of index event Part or all of the patient's first-line treatment was received at a different site and the patient's medical chart pertaining to this care is not accessible Patient medical chart is missing, empty, or not retrievable Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Advanced Melanoma patients who intiated first-line therapy<br>patients who initiated any first-line therapy for advanced melanoma and had not previously received treatment for their advanced disease | Other: Non-interventional<br>* Non-interventional<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Overall Response (BOR) rate | In a subset of patients treated with first-line nivolumab + ipilimumab combination therapy | Up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of patient demographic characteristics | Including age, sex, ethnic group, height, weight, and BMI | At baseline | 
| Prior melanoma treatment history | Type of intervention used to treat melanoma | At baseline | 
| Serum concentration of lactate dehydrogenase (LDH) |  | At baseline | 
| Eastern Cooperative Oncology Group (ECOG) score |  | Up to 18 months | 
| Distribution of first-line treatment patterns | Details on Treatment Patterns will be summarized using descriptive statistics | Up to 18 months | 
| Distribution of subsequent therapy line treatment patterns | Details on Treatment Patterns will be summarized using descriptive statistics | Up to 18 months | 
| Progression Free Survival (PFS) | Time from first-line initiation until disease progression or death in a subset of patients treated with first-line nivolumab + ipilimumab combination therapy | Up to 18 months | 
| Treatment-Free Interval (TFI) | Time from nivolumab + ipilimumab combination therapy discontinuation to date of progressive disease in a subset of patients treated with first-line nivolumab + ipilimumab combination therapy | Up to 18 months | 
| Overall Survival (OS) | Time from treatment initiation until death in a subset of patients treated with first-line nivolumab + ipilimumab combination therapy | Up to 18 months | 
| Distribution of PD-L1 threshold | PD-L1 threshold used for first-line treatment selection in patients where PD-L1 was tested | At baseline | 
| Incidence of adverse events of Special interest(AESI) | in a subset of patients receiving nivolumab + ipilimumab combo therapy. AESIs include select gastrointestinal, renal, pulmonary, hepatic, endocrine, skin, neurological, and infusion reaction. | Up to 18 months | 
| Incidence of serious adverse events (SAE) | in a subset of patients receiving nivolumab + ipilimumab combo therapy. SAE defined as Common Terminology Criteria for Adverse Events (CTCAE) grades 3+ adverse events | Up to 18 months | 
| Distribution of AESI management | In a subset of patients receiving Nivo + Ipi combo therapy | up to 18 months | 
| melanoma related healthcare resource utilization (HCRU) |  | Up to 18 months |