Melanoma Clinical Trial

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

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.

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Full Description

The NOBLE database was built from the harmonization of two customized oncology specific EHR databases: Flatiron Health Spotlight and Concerto Custom Patient360. BRAF v600 mutated advanced (i.e., stage III or IV) patients treated at oncology practices across the US were identified in these two databases for potential inclusion. Both the Flatiron Health EHR-derived database and the Concerto Patient360 database contain clinical, demographic, treatment, and mortality information for melanoma patients from the time of initial diagnosis until death or the most recent data cut-off, which is August 31, 2020 (for population 1), and May 31, 2020 (for population 2).

For population 1 (patients treated 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 Immunotherapy (IO) (e.g., Nivolumab (nivo) or Pembrolizumab (pembro)) or Targeted Therapy (TT) (e.g., Dabrafenib+ Trametinib (dab+tram)) on or after January 1, 2014 and prior to August 30,2020 (data cut-off), and any evidence of a BRAF+ result. Patients were required to have at least 6 months of follow-up after initiation of adjuvant treatment. Patients were followed until the earlier of death, data cut-off, loss of follow-up, or received MM diagnosis. While the first systemic therapy approved for use in the adjuvant melanoma setting occurred in 2015, the study period of interest begins on January 1, 2014, to include any potential off-label use of these therapies as adjuvant therapies.

For population 2 (patients with Low tumor burden (LTB) treated 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. Ipilimumab (ipi), nivo, pembro, ipi+nivo) or TT (dab+tram, Vemurafenib+Cobimetinib, Encorafenib+Binimetinib (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. To align with recent FDA approvals for combination therapies use in MM setting, study period interest began on January 1, 2014. Furthermore, this sampling interval allowed a maximum 6 years follow-up from start period.

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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 2011
Evidence of resection
Adjuvant treatment with IO (nivo, pembro) or TT (dab+tram) on or after 1/1/2014 and prior to 8/31/2020
At 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 therapy
Evidence of a BRAF+ result ≤30 days after therapy initiation in the adjuvant setting
At least 18 years of age at the time of initiation of treatment
No documented receipt of a clinical trial treatment for cancer at any time on or after January 1, 2014

Population 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 1/1/2011
1L 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 5/31/2020
At least 6 months of follow-up time (until death, loss of follow-up, or end of data cut-off) from the initiation of therapy
Evidence of a BRAF+ result ≤30 days after 1L therapy initiation
LTB, defined as having <3 involved organ sites and normal LDH test (less than upper limit of normal) at the time receiving MM diagnosis
At least 18 years of age at the time of initiation of 1L treatment
No documented receipt of a clinical trial treatment for cancer at any time on or after 1/1/2014

Exclusion Criteria:

None

Study is for people with:

Melanoma

Estimated Enrollment:

1975

Study ID:

NCT05611229

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There is 1 Location for this study

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Novartis Investigative Site
East Hanover New Jersey, 07936, United States

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Study is for people with:

Melanoma

Estimated Enrollment:

1975

Study ID:

NCT05611229

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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