Retrospective Chart Review Study of First-Line Treatment Patterns and Clinical Outcomes in Patients with Advanced (Unresectable or Metastatic) Melanoma in the United Kingdom (1L Melanoma Chart Review Study in UK)

Study identification

• EU PAS number:
  EUPAS20861
• Study ID:
  22040
• Official title and acronym:
  Retrospective Chart Review Study of First-Line Treatment Patterns and Clinical Outcomes in Patients with Advanced (Unresectable or Metastatic) Melanoma in the United Kingdom (1L Melanoma Chart Review Study in UK)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Main study objective is to describe the first-line best overall response (BOR) rate in a subset of treatment-naïve patients who received first-line regimen (nivolumab + ipilimumab). Secondary objectives are to describe first-line systemic therapy treatment patterns for advanced (unresectable or metastatic) melanoma and systemic therapy sequencing patterns including the proportion of patients who are tested for PD-L1 status including threshold used for first-line treatment selection. In a subset of patients who received first-line regimen (nivolumab + ipilimumab), additional outcome measures are: treatment-free interval (TFI), progression-free survival (PFS), the proportion of patients remaining on treatment following disease progression, 12 months overall survival (OS), adverse events of special interest (AESI) (includes select gastrointestinal, renal, pulmonary, hepatic, endocrine, skin, neurological, and infusion reactions) and serious adverse events (SAEs) (CTCAE grades 3+ AEs) including AESI management (prophylaxis and treatment), and healthcare resource utilisation (HRU). Exploratory objectives include describing factors associated with first-line treatment selection and predictors of first-line treatment response in a subset of patients treated with regimen.
• Study status:
  Planned

Research institutions and networks

Institutions

Addenbrooke's Hospital

Study timelines

Date when funding contract was signed

Actual:23/06/2017

Study start date

Planned:19/12/2017

Data analysis start date

Planned:03/04/2018

Date of final study report

Planned:01/05/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb Research and Development

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

CA209-9TW