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

Novartis

Status: Completed

Conditions: BRAF Positive Metastatic Melanoma

Study type: Observational

Funder types: Industry

Identifiers

NCT05984615

CTMT212AUS63

Details and patient eligibility

About

This was a retrospective real-world evidence cohort study.

Enrollment: 1,961 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,961 participants in 2 patient groups

Immunotherapy (IO) Cohort

Targeted Therapy (TT) Cohort