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OpenTrials
Completed

NCT Number: NCT03448497

Study of First-line Treatment Patterns and Clinical Outcomes in Patients With Advanced 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Cambridge, Cambridgeshire, CB16GQ, United Kingdom

Who can participate

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

  • 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

Treatment and study plan

Non-Interventional

Other

Non-interventional

Primary outcomes

  1. Best Overall Response (BOR) rate

    Time frame: Up to 18 months

    In a subset of patients treated with first-line nivolumab + ipilimumab combination therapy

Secondary outcomes

  1. Distribution of patient demographic characteristics

    Time frame: At baseline

    Including age, sex, ethnic group, height, weight, and BMI

  2. Prior melanoma treatment history

    Time frame: At baseline

    Type of intervention used to treat melanoma

  3. Serum concentration of lactate dehydrogenase (LDH)

    Time frame: At baseline

  4. Eastern Cooperative Oncology Group (ECOG) score

    Time frame: Up to 18 months

  5. Distribution of first-line treatment patterns

    Time frame: Up to 18 months

    Details on Treatment Patterns will be summarized using descriptive statistics

  6. Distribution of subsequent therapy line treatment patterns

    Time frame: Up to 18 months

    Details on Treatment Patterns will be summarized using descriptive statistics

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  12. 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

  13. Distribution of AESI management

    Time frame: up to 18 months

    In a subset of patients receiving Nivo + Ipi combo therapy

  14. melanoma related healthcare resource utilization (HCRU)

    Time frame: Up to 18 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 28, 2018
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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