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

Melanoma Clinical Trial

Official title:

Retrospective Chart Review Study of First-line Treatment Patterns and Clinical Outcomes in Patients With Advanced (Unresectable or Metastatic) Melanoma in the United Kingdom

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448497
• Other study ID #: CA209-9TW
• Status: Completed
• Start date: December 14, 2017
• Est. completion date: April 27, 2018

Study information

• Verified date: August 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: April 27, 2018
• Est. primary completion date: April 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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/exclusion criteria could apply

Related Conditions & MeSH terms

• Melanoma

Intervention

Other:
• Non-interventional
Non-interventional

Locations

Country	Name	City	State
United Kingdom	Local Institution	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Overall Response (BOR) rate	In a subset of patients treated with first-line nivolumab + ipilimumab combination therapy	Up to 18 months
Secondary	Distribution of patient demographic characteristics	Including age, sex, ethnic group, height, weight, and BMI	At baseline
Secondary	Prior melanoma treatment history	Type of intervention used to treat melanoma	At baseline
Secondary	Serum concentration of lactate dehydrogenase (LDH)		At baseline
Secondary	Eastern Cooperative Oncology Group (ECOG) score		Up to 18 months
Secondary	Distribution of first-line treatment patterns	Details on Treatment Patterns will be summarized using descriptive statistics	Up to 18 months
Secondary	Distribution of subsequent therapy line treatment patterns	Details on Treatment Patterns will be summarized using descriptive statistics	Up to 18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Distribution of PD-L1 threshold	PD-L1 threshold used for first-line treatment selection in patients where PD-L1 was tested	At baseline
Secondary	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
Secondary	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
Secondary	Distribution of AESI management	In a subset of patients receiving Nivo + Ipi combo therapy	up to 18 months
Secondary	melanoma related healthcare resource utilization (HCRU)		Up to 18 months

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form