A Randomized, Phase 3, Open-label Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 13
- 主要终点
- Median relapse-free survival
研究概览
简要总结
This is a randomized, multi-center, open-label study of adjuvant darovasertib in participants with non-metastatic uveal melanoma (OptimUM-11)
详细描述
This study will enroll participants who are at high-risk for metastatic disease and who have completed primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation) for their UM without evidence of active local or metastatic disease after this treatment.
The Treatment Arm will have participants who have completed PLT and will receive darovasertib + crizotinib.
The Observation Arm participants will not receive darovasertib + crizotinib but will be observed and followed for disease recurrence and survival (Control Arm)
Participants in both arms will be followed for up to five years to assess longer term outcomes such as tumor recurrence and survival.
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 Uveal Melanoma, classified as high-risk of relapse (AJCC Stage II or Stage 3)
- •Completed primary local therapy (enucleation, proton beam therapy, plaque brachytherapy)
- •ECOG performance status of 0 or 1
- •Adequate organ function
- •Age 18 or older
- •Written informed consent and ability to comply
- •Primary local therapy completed within 120 days before C1D1/randomization.
- •Contraception requirements
排除标准
- •Previous systemic treatment for Uveal Melanoma
- •Clinical or radiological evidence of metastatic UM
- •Concurrent malignant disease with the following exceptions: malignancies that were treated curatively and have not recurred within 2 years prior to randomization, completely resected basal cell and squamous cell skin cancers, any malignancy considered to be indolent and never required systemic therapy, and any type of carcinoma in situ receiving curative therapy (resection)
- •Known AIDS related illness
- •History of interstitial lung disease, active pneumonitis, or history of noninfectious pneumonitis requiring steroids
- •History of syncope may be exclusionary, but will be reviewed on a case-by-case basis
- •Active Hepatitis B or C infection
- •Any gastrointestinal condition (eg, inflammatory bowel disease, major gastric or intestinal surgery) that could affect absorption or ability to swallow
- •Females who are pregnant or breastfeeding
- •Impaired cardiac function
- •History of stroke within the last 6 months of randomization
- •Ongoing use of medication use for infections, other antineoplastic therapies, or other prohibited medications, including medications that interact with the metabolism of darovasertib+crizotinib
- •allergy to mammalian meat products or gelatin
研究组 & 干预措施
Treatment
Participant Group/Arm: Treatment combination dose of IDE196 + crizotinib will be tested
干预措施: Darovasertib (Drug)
Observation
Participant Group/Arm: Observation Standard of care observation & follow-up (no treatment)
Treatment
Participant Group/Arm: Treatment combination dose of IDE196 + crizotinib will be tested
干预措施: Crizotinib (Xalkori) (Drug)
结局指标
主要结局
Median relapse-free survival
时间窗: Approximately 5 years
Time to local recurrence or metastatic disease per Blinded Independent Central Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
次要结局
- Metastasis-Free Survival(Approximately 5 years)
- Median Local Recurrence-Free Survival(Approximately 5 years)
- Change from baseline over time and across Treatment Arms as measured by European Quality of Life Questionnaire EQ-5D-5L.([Time Frame: Approximately 5 years])
- Median metastasis-free survival(Approximately 5 years)
- Overall survival(Approximately 5 years)
- Median UM specific survival(Approximately 5 years)
- Safety, and severity of occurrence of adverse events (AEs) as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) V6.0 or later(Approximately 3 years)
- Change from baseline over time and across Treatment Arms as measured by EORTC Oncology Quality of Life Questionnaire Ophthalmic-30 (EORTC QLQ-OPT30)([Time Frame: Approximately 5 years])
- Change from baseline over time and across Treatment Arms as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30)(Approximately 5 years)
- Recurrence-free suvival(Approximately 5 years)