A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 520
- 试验地点
- 152
- 主要终点
- Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm
研究概览
简要总结
This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
详细描述
The study is divided into 2 cohorts of patients with primary uveal melanoma requiring either plaque brachytherapy or enucleation.
In cohort 1, patients in the treatment arm will receive neoadjuvant darovasertib followed by plaque brachytherapy compared to immediate plaque brachytherapy (control arm).
In cohort 2, the treatment arm will receive neoadjuvant darovasertib followed by definitive primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation). Subjects in the control arm will go onto immediate enucleation.
Subjects will then receive primary local therapy following neoadjuvant darovasertib.
All patients will be followed for up to 3 years to assess longer term outcomes such as vision and tumor recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Primary non-metastatic uveal melanoma
- •Able and willing to provide written, informed consent before initiation of any study-related procedures, and in the opinion of the Investigator, to comply with all study requirements
- •ECOG 0 or 1
- •Adequate organ function
排除标准
- •Previous treatment for UM
- •Evidence of metastatic UM
- •Attributes that necessitate enucleation regardless of response to therapy
- •Evidence of progressive secondary underlying ocular disease that would confound longitudinal VA assessments
- •Presence of a malignant disease other than the one being treated in this study
研究组 & 干预措施
Treatment Arm
Darovasetib followed by definitive primary local therapy (i.e., PB, proton beam radiation, or enucleation)
干预措施: Darovasertib (Drug)
Control Arm
Immediate Primary Local therapy
干预措施: Primary Local Therapy (Procedure)
结局指标
主要结局
Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm
时间窗: Approximately 3 years
Loss of Best Corrected Visual Acuity (BCVA) of ≥ 15 letters using Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA
Cohort 2: To demonstrate the ability to salvage the eye and prevent enucleation in the Treatment Arm
时间窗: Approximately 2 years
Eye preservation rate
次要结局
未报告次要终点