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

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ClinicalTrials.gov Identifier: NCT03448497
Recruitment Status : Active, not recruiting
First Posted : February 28, 2018
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment
Melanoma Other: Non-interventional

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : August 27, 2018
Estimated Study Completion Date : November 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448497


Locations
United Kingdom
Local Institution
Cambridge, Cambridgeshire, United Kingdom, CB16GQ
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03448497     History of Changes
Other Study ID Numbers: CA209-9TW
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas