Local Institution
Cambridge, Cambridgeshire, CB16GQ, United Kingdom
NCT Number: NCT03448497
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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Notify Me18 year and older
All sexes
Observational
Cambridge, Cambridgeshire, CB16GQ, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Non-interventional
Time frame: Up to 18 months
In a subset of patients treated with first-line nivolumab + ipilimumab combination therapy
Time frame: At baseline
Including age, sex, ethnic group, height, weight, and BMI
Time frame: At baseline
Type of intervention used to treat melanoma
Time frame: At baseline
Time frame: Up to 18 months
Time frame: Up to 18 months
Details on Treatment Patterns will be summarized using descriptive statistics
Time frame: Up to 18 months
Details on Treatment Patterns will be summarized using descriptive statistics
Time frame: 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
Time frame: 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
Time frame: Up to 18 months
Time from treatment initiation until death in a subset of patients treated with first-line nivolumab + ipilimumab combination therapy
Time frame: At baseline
PD-L1 threshold used for first-line treatment selection in patients where PD-L1 was tested
Time frame: 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.
Time frame: 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
Time frame: up to 18 months
In a subset of patients receiving Nivo + Ipi combo therapy
Time frame: Up to 18 months
Bristol-Myers Squibb
Industry
Retrospective Chart Review Study of First-line Treatment Patterns and Clinical Outcomes in Patients With Advanced (Unresectable or Metastatic) Melanoma in the United Kingdom
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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