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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced Melanoma patients who intiated first-line therapy | patients who initiated any first-line therapy for advanced melanoma and had not previously received treatment for their advanced disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional | Other | Non-interventional |
|
| 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 |
| 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 |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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The study population includes treatment-naïve patients with advanced (unresectable or metastatic) melanoma who initiated first-line therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Cambridge | Cambridgeshire | CB16GQ | United Kingdom |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| 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 |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |