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OpenTrials
Completed

NCT Number: NCT05984615

Real-world Evaluation of the Impact of Baseline Metastases on Clinical Outcomes Among BRAF Positive Metastatic Melanoma Patients

This was a retrospective real-world evidence cohort study.

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Key information

Conditions

BRAF Positive Metastatic Melanoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of melanoma (The International Classification of Diseases, 9th Revision [ICD-9] 172.x & 10th revision [ICD-10] C43 or D03x).
  • Pathologic stage IV at initial diagnosis on or after 01 January 2011.
  • First-line treatment with IO monotherapy or combination therapy (nivolumab, pembrolizumab, ipilimumab + nivolumab) or TT combination therapy (dabrafenib + trametinib, vemurafenib+cobimetinib, encorafenib+binimetinib) on or after 01 January 2014.
  • Evidence of a BRAF test.
  • Evidence of a BRAF-positive result prior to or up to 30 days after first-line (1L) therapy initiation.
  • At least 18 years of age at the time of initiation of 1L treatment.

Exclusion criteria

  • Documented receipt of a clinical trial treatment for cancer at any time on or after 01 January 2014.
  • Diagnosis of a second primary cancer or secondary cancer following initiation of 1L metastatic melanoma (MM) treatment.

Treatment and study plan

Primary outcomes

  1. Mean age

    Time frame: Baseline

  2. Number of male patients

    Time frame: Baseline

  3. Race

    Time frame: Baseline

  4. Mean Charlson comorbidity index (CCI) score

    Time frame: Baseline

    Comorbidity was categorized into three grades: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5.

  5. Eastern Cooperative Oncology Group performance status (ECOG PS)

    Time frame: Baseline

    The ECOG scale consists of 4 grades (from 0 to 4) where 0 implies fully active, and 4 implies completely disabled.

  6. Number of patients with study-related biomarkers

    Time frame: Baseline

    Study-related biomarkers included BRAF and PD1/PDL1 test dates and results.

  7. Number of metastatic sites

    Time frame: Baseline

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: 6 months and 1, 1.5, and 2 years

    PFS was defined as the time from the initiation of a line of therapy until the date of progression or death.

  2. Overall survival (OS)

    Time frame: 6 months and 1, 1.5, and 2 years

    OS was defined as the time from the initiation of a line of therapy until death from any cause.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2023
Registry last updated
Aug 9, 2023

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.