Treatment Patterns and Outcomes of Targeted Therapy and Immunotherapy Among BRAF-Positive Melanoma Patients Treated in the Adjuvant Setting and Among BRAF-Positive Metastatic Melanoma Patients With Low Tumor Burden

Part of paid clinical trials in East Hanover, New Jersey.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05611229
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab
  • Pembrolizumab — DRUG
    Pembrolizumab
  • Dabrafenib+Trametinib — COMBINATION_PRODUCT
    Dabrafenib+Trametinib
  • Ipilimumab+Nivolumab — COMBINATION_PRODUCT
    Ipilimumab+Nivolumab
  • Vemurafenib+Cobimetinib — COMBINATION_PRODUCT
    Vemurafenib+Cobimetinib
  • Encorafenib+Binimetinib — COMBINATION_PRODUCT
    Encorafenib+Binimetinib

Study Details

This was an observational study utilizing electronic health record (EHR)-derived data collected retrospectively during routine care of real-world patients with advanced melanoma from NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset.

Key Dates

Start date
Jun 16, 2020
Status verified
Apr 2023
Primary completion
Dec 3, 2021
Completion
Dec 3, 2021

Study Design

Enrollment
1,975 participants (actual)

Arms

  • Arm: Population 1: BRAF+ melanoma patients treated with either TT or IO in the adjuvant setting
    Included patients were aged more than or equal to 18 years, were required to have a diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43.x or D03.x), pathologic stage III disease, evidence of resection, adjuvant treatment with IO (e.g., nivo or pembro) or TT (e.g., dab+tram) on or after January 1, 2014, and prior to August 30,2020 (data cut-off), and any evidence of a BRAF+ result.
  • Arm: Population 2: BRAF+ melanoma patients with LTB treated with TT or IO in the metastatic setting
    Included patients were aged more than or equal to 18 years, and were required to have a diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43 or D03x), a pathologic stage IV diagnosis, treatment with IO (e.g. ipi, nivo, pembro, ipi+nivo) or TT (dab+tram, vem+cobi, enco+bini) on or after January 1, 2014 and prior to May 31, 2020 (data cut-off), and evidence of a BRAF+ result after therapy initiation. Patients were required to be classified as LTB at the time of stage IV diagnosis. LTB was defined as having normal LDH and \<3 metastatic sites at the time of stage IV diagnosis.

Primary Outcome Measure

Proportion of patients receiving TT and IO therapy in the first-, and second-line [ Time Frame: throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteEast HanoverNew Jersey07936-

Find similar trials in East Hanover, NJ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Novartis Investigative Site· East Hanover, NJ

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