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Completed
NCT05611229
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
Conditions: Metastatic Melanoma
Sex: All
Ages: 18 Years – N/A
Enrollment: 1975
Sponsor: Novartis Pharmaceuticals
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:Population 1(patients treated in the adjuvant setting)Diagnosis of melanoma (ICD-9 172.x & ICD-10 C43.x or D03.x)Pathologic stage III on or after 2011Evidence of resectionAdjuvant treatment with IO (nivo, pembro) or TT (dab+tram) on or after 1/1/2014 and prior to 8/31/2020At least 6 months of follow-up time (until death, end of data cut-off, loss-of-follow-up, or progressed to stage IV diagnosis) from the initiation of therapyEvidence of a BRAF+ result ≤30 days after therapy initiation in the adjuvant settingAt least 18 years of age at the time of initiation of treatmentNo documented receipt of a clinical trial treatment for cancer at any time on or after January 1, 2014Population 2 (patients with LTB treated in the metastatic setting)Diagnosis of melanoma (ICD-9 172.x & ICD-10 C43.x or D03.x)Pathologic stage IV at initial diagnosis on or after 1/1/2011, or earlier stage disease accompanied by development of a first locoregional recurrence on or after 1/1/20111L treatment with IO (ipi, nivo, pembro, ipi+nivo) or TT (dab+tram, vemu+cobi, enco+bini) on or after 1/1/2014 and prior to 5/31/2020At least 6 months of follow-up time (until death, loss of follow-up, or end of data cut-off) from the initiation of therapyEvidence of a BRAF+ result ≤30 days after 1L therapy initiationLTB, defined as having <3 involved organ sites and normal LDH test (less than upper limit of normal) at the time of receiving MM diagnosisAt least 18 years of age at the time of initiation of 1L treatmentNo documented receipt of a clinical trial treatment for cancer at any time on or after 1/1/2014Exclusion Criteria:None
Source: ClinicalTrials.gov (NCT05611229). StuddyBuddy aggregates publicly available trial information.