Relapse-Free Survival With Adjuvant Dabrafenib/Trametinib Therapy After Relapse on Adjuvant Checkpoint Inhibitor Therapy and Subsequent Surgical Resection in Patients With BRAF V600-mutated Stage III/IV Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Relapse-free Survival-2 (RFS-2)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient at least 18 years of age at the time of diagnosis of stage III/IV melanoma.
- •Received surgical resection with no residual disease following initial stage III/IV melanoma diagnosis.
- •Documented local or central assay-positive for tumor BRAF V600E/K mutation.
- •Received adjuvant CPI alone or in combination with any other immune treatment as their first adjuvant therapy.
- •Following adjuvant CPI, relapsed (locoregionally or distantly) on or off treatment and was again rendered free of disease after subsequent surgical resection.
- •Received additional adjuvant dab/tram combination therapy after failing adjuvant CPI and being subsequently resected to NED.
排除标准
- •Previous administration of any BRAF- or mitogen-activated protein kinase (MEK)-targeted therapies.
- •More than 120 days duration between surgery to render the patient NED after relapsing during or after adjuvant CPI therapy and initiation of dab/tram adjuvant therapy.
- •Administration of any intervening antitumor medical and/or radiation therapy between failing adjuvant CPI and initiation of adjuvant dab/tram.
结局指标
主要结局
Relapse-free Survival-2 (RFS-2)
时间窗: Up to 63 months
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.
次要结局
- Mean Number of Times an AE Related to Dabrafenib and Trametinib Combination Therapy was Experienced(Up to 63 months)
- Overall Survival (OS)(Up to 63 months)
- Distant Metastases-free Survival (DMFS)(Up to 63 months)
- Number of Patients with an Adverse Event (AE) Related to Dabrafenib and Trametinib Combination Therapy(Up to 63 months)