Melanoma
Conditions
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.
Interventions
OTHERNon-interventional
Non-interventional
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Response (BOR) rate | Up to 18 months | In a subset of patients treated with first-line nivolumab + ipilimumab combination therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prior melanoma treatment history | At baseline | Type of intervention used to treat melanoma |
| Serum concentration of lactate dehydrogenase (LDH) | At baseline | — |
| Eastern Cooperative Oncology Group (ECOG) score | Up to 18 months | — |
| Distribution of first-line treatment patterns | Up to 18 months | Details on Treatment Patterns will be summarized using descriptive statistics |
| Distribution of subsequent therapy line treatment patterns | Up to 18 months | Details on Treatment Patterns will be summarized using descriptive statistics |
| Progression Free Survival (PFS) | Up to 18 months | Time from first-line initiation until disease progression or death in a subset of patients treated with first-line nivolumab + ipilimumab combination therapy |
| Distribution of patient demographic characteristics | At baseline | Including age, sex, ethnic group, height, weight, and BMI |
| Treatment-Free Interval (TFI) | Up to 18 months | 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 |
| Overall Survival (OS) | Up to 18 months | Time from treatment initiation until death in a subset of patients treated with first-line nivolumab + ipilimumab combination therapy |
| Distribution of PD-L1 threshold | At baseline | PD-L1 threshold used for first-line treatment selection in patients where PD-L1 was tested |
| Incidence of adverse events of Special interest(AESI) | Up to 18 months | in a subset of patients receiving nivolumab + ipilimumab combo therapy. AESIs include select gastrointestinal, renal, pulmonary, hepatic, endocrine, skin, neurological, and infusion reaction. |
| Incidence of serious adverse events (SAE) | Up to 18 months | in a subset of patients receiving nivolumab + ipilimumab combo therapy. SAE defined as Common Terminology Criteria for Adverse Events (CTCAE) grades 3+ adverse events |
| Distribution of AESI management | up to 18 months | In a subset of patients receiving Nivo + Ipi combo therapy |
| melanoma related healthcare resource utilization (HCRU) | Up to 18 months | — |
Countries
United Kingdom
Outcome results
None listed