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This was a retrospective chart review study of all proto-oncogene B-Raf (BRAF) V600-mutated patients who received adjuvant checkpoint inhibitor (CPI) therapy, relapsed locoregionally or distantly, and were again resected to no evidence of disease (NED) and treated with adjuvant dabrafenib and trametinib (dab/tram) combination therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabrafenib and Trametinib Combination Therapy Cohort | Adult BRAF V600 patients with resected stage III/IV melanoma that relapsed during or after CPI as their first adjuvant therapy and were again rendered free of disease and received adjuvant dab/tram combination therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free Survival-2 (RFS-2) | RFS-2 was defined as the time from the study index date until the date of the earliest clinician-documented disease progression, death, or start of a new line of anticancer treatment due to disease progression. Patients without a progression event as described above were censored at the last available follow-up, defined as last known clinic visit or last known contact with the patient (if occurred outside the clinic setting). Index date was defined as the date that dab/tram combination therapy was initiated after being rendered disease-free for a second time following additional resection after prior relapse on initial CPI adjuvant therapy. | Up to 63 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from the study index date until death due to any cause. Patients without a death event were censored at last available follow-up, defined as last known clinic visit or last known contact with the patient (if occurred outside the clinic setting). Index date was defined as the date that dab/tram combination therapy was initiated after being rendered disease-free for a second time following additional resection after prior relapse on initial CPI adjuvant therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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This was a retrospective, noninterventional cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | East Hanover | New Jersey | 07936 | United States |
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| Up to 63 months |
| Distant Metastases-free Survival (DMFS) | DMFS was defined as the time from the study index date until the first observation of disease progression with distant metastasis. Patients without a DMFS event as described above were censored at last available follow-up, defined as last known clinic visit or last known contact with the patient (if occurred outside the clinic setting). Index date was defined as the date that dab/tram combination therapy was initiated after being rendered disease-free for a second time following additional resection after prior relapse on initial CPI adjuvant therapy. | Up to 63 months |
| Number of Patients with an Adverse Event (AE) Related to Dabrafenib and Trametinib Combination Therapy | Up to 63 months |
| Mean Number of Times an AE Related to Dabrafenib and Trametinib Combination Therapy was Experienced | Up to 63 months |