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

August 5, 2019 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

333

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB16GQ
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population includes treatment-naïve patients with advanced (unresectable or metastatic) melanoma who initiated first-line therapy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Non-interventional
Non-interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Overall Response (BOR) rate
Time Frame: Up to 18 months
In a subset of patients treated with first-line nivolumab + ipilimumab combination therapy
Up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of patient demographic characteristics
Time Frame: At baseline
Including age, sex, ethnic group, height, weight, and BMI
At baseline
Prior melanoma treatment history
Time Frame: At baseline
Type of intervention used to treat melanoma
At baseline
Serum concentration of lactate dehydrogenase (LDH)
Time Frame: At baseline
At baseline
Eastern Cooperative Oncology Group (ECOG) score
Time Frame: Up to 18 months
Up to 18 months
Distribution of first-line treatment patterns
Time Frame: Up to 18 months
Details on Treatment Patterns will be summarized using descriptive statistics
Up to 18 months
Distribution of subsequent therapy line treatment patterns
Time Frame: Up to 18 months
Details on Treatment Patterns will be summarized using descriptive statistics
Up to 18 months
Progression Free Survival (PFS)
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
Up to 18 months
Treatment-Free Interval (TFI)
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
Up to 18 months
Overall Survival (OS)
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
Up to 18 months
Distribution of PD-L1 threshold
Time Frame: At baseline
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)
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.
Up to 18 months
Incidence of serious adverse events (SAE)
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
Up to 18 months
Distribution of AESI management
Time Frame: up to 18 months
In a subset of patients receiving Nivo + Ipi combo therapy
up to 18 months
melanoma related healthcare resource utilization (HCRU)
Time Frame: Up to 18 months
Up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2017

Primary Completion (Actual)

April 27, 2018

Study Completion (Actual)

April 27, 2018

Study Registration Dates

First Submitted

February 12, 2018

First Submitted That Met QC Criteria

February 27, 2018

First Posted (Actual)

February 28, 2018

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-9TW

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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