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

Completed

• Conditions: Melanoma
• Interventions: Other: Non-interventional

• Registration Number: NCT03448497
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-12-14
• Study First Submitted: 2018-02-12
• Study First Submitted QC: 2018-02-27
• Study First Posted: 2018-02-28
• Primary Completion: 2018-04-27
• Study Completion: 2018-04-27
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 333

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Advanced Melanoma patients who intiated first-line therapy	Non-interventional	patients who initiated any first-line therapy for advanced melanoma and had not previously received treatment for their advanced disease

Primary Outcome Measures

Name	Time	Method
Best Overall Response (BOR) rate	Up to 18 months	In a subset of patients treated with first-line nivolumab + ipilimumab combination therapy

Secondary Outcome Measures

Name	Time	Method
Serum concentration of lactate dehydrogenase (LDH)	At baseline
Distribution of PD-L1 threshold	At baseline	PD-L1 threshold used for first-line treatment selection in patients where PD-L1 was tested
Distribution of AESI management	up to 18 months	In a subset of patients receiving Nivo + Ipi combo therapy
Prior melanoma treatment history	At baseline	Type of intervention used to treat melanoma
Distribution of subsequent therapy line treatment patterns	Up to 18 months	Details on Treatment Patterns will be summarized using descriptive statistics
Distribution of first-line treatment patterns	Up to 18 months	Details on Treatment Patterns will be summarized using descriptive statistics
Eastern Cooperative Oncology Group (ECOG) score	Up to 18 months
melanoma related healthcare resource utilization (HCRU)	Up to 18 months
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
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
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 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

Trial Locations

Locations (1)

Local Institution; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom