Clinical trial NCT03448497: Study of First-line Treatment Patterns and Clinical Outcomes in Patients With Advanced Melanoma in the United Kingdom
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-02-28
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Best Overall Response (BOR) rate
timeFrame: Up to 18 months
Secondary outcomes:
measure: Distribution of patient demographic characteristics
timeFrame: At baseline
measure: Prior melanoma treatment history
timeFrame: At baseline
measure: Serum concentration of lactate dehydrogenase (LDH)
timeFrame: At baseline
measure: Eastern Cooperative Oncology Group (ECOG) score
timeFrame: Up to 18 months
measure: Distribution of first-line treatment patterns
timeFrame: Up to 18 months
measure: Distribution of subsequent therapy line treatment patterns
timeFrame: Up to 18 months
measure: Progression Free Survival (PFS)
timeFrame: Up to 18 months
measure: Treatment-Free Interval (TFI)
timeFrame: Up to 18 months
measure: Overall Survival (OS)
timeFrame: Up to 18 months
measure: Distribution of PD-L1 threshold
timeFrame: At baseline
measure: Incidence of adverse events of Special interest(AESI)
timeFrame: Up to 18 months
measure: Incidence of serious adverse events (SAE)
timeFrame: Up to 18 months
measure: Distribution of AESI management
timeFrame: up to 18 months
measure: melanoma related healthcare resource utilization (HCRU)
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Local Institution
state: Cambridgeshire
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: