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.
Study Type
OBSERVATIONAL
Enrollment
333
Non-interventional
Local Institution
Cambridge, Cambridgeshire, United Kingdom
Best Overall Response (BOR) rate
In a subset of patients treated with first-line nivolumab + ipilimumab combination therapy
Time frame: Up to 18 months
Distribution of patient demographic characteristics
Including age, sex, ethnic group, height, weight, and BMI
Time frame: At baseline
Prior melanoma treatment history
Type of intervention used to treat melanoma
Time frame: At baseline
Serum concentration of lactate dehydrogenase (LDH)
Time frame: At baseline
Eastern Cooperative Oncology Group (ECOG) score
Time frame: Up to 18 months
Distribution of first-line treatment patterns
Details on Treatment Patterns will be summarized using descriptive statistics
Time frame: Up to 18 months
Distribution of subsequent therapy line treatment patterns
Details on Treatment Patterns will be summarized using descriptive statistics
Time frame: 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
Time frame: Up to 18 months
Treatment-Free Interval (TFI)
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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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Up to 18 months
Distribution of AESI management
In a subset of patients receiving Nivo + Ipi combo therapy
Time frame: up to 18 months
melanoma related healthcare resource utilization (HCRU)
Time frame: Up to 18 months