Status:
COMPLETED
Real-world Evaluation of the Impact of Baseline Metastases on Clinical Outcomes Among BRAF Positive Metastatic Melanoma Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
BRAF Positive Metastatic Melanoma
Eligibility:
All Genders
18+ years
Brief Summary
This was a retrospective real-world evidence cohort study.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 8 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 24 2022
Estimated Enrollment :
1961 Patients enrolled
Trial Details
Trial ID
NCT05984615
Start Date
June 8 2022
End Date
August 24 2022
Last Update
August 9 2023
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States, 07936