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Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma

2026年9月11日 更新者：IDEAYA Biosciences

A Randomized, Phase 3, Open-label Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma

This is a randomized, multi-center, open-label study of adjuvant darovasertib in participants with non-metastatic uveal melanoma (OptimUM-11)

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

450

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 加拿大
    • Ontario
      • Montréal、Ontario、加拿大、H2X0C1
        • 尚未招聘
        • Universite de Montreal - Centre de Recherche du Centre Hospitalier de l'Universite de Montreal
        • 接触：
      • Toronto、Ontario、加拿大、M5G 2M9
        • 招聘中
        • Princess Margaret Cancer Centre
        • 接触：
          • Marcus Butler, MD
  • 美国
    • Arizona
      • Scottsdale、Arizona、美国、85258
        • 招聘中
        • Honor Health Research Institute
        • 接触：
    • California
      • Los Angeles、California、美国、90024
    • Massachusetts
      • Boston、Massachusetts、美国、02215
    • Michigan
      • Grand Rapids、Michigan、美国、49503
        • 尚未招聘
        • Cancer Hematology Centers Western Michigan
        • 接触：
    • New York
      • New York、New York、美国、10065
        • 尚未招聘
        • Memorial Sloan Kettering Cancer Center
        • 接触：
      • New York、New York、美国、10075
        • 尚未招聘
        • Northwell Health
        • 接触：
    • North Carolina
      • Raleigh、North Carolina、美国、27710
        • 尚未招聘
        • Duke Cancer Center
        • 接触：
    • Ohio
      • Cleveland、Ohio、美国、44195
        • 尚未招聘
        • Cleveland Clinic
        • 接触：
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19107
        • 招聘中
        • Wills Eye Hospital at Thomas Jefferson University
        • 接触：
    • Tennessee
      • Nashville、Tennessee、美国、37203
        • 招聘中
        • Sarah Cannon Research Institute (SCRI)
        • 接触：
    • Wisconsin
      • Madison、Wisconsin、美国、53792
        • 尚未招聘
        • University of Wisconsin Health
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Treatment
Participant Group/Arm: Treatment combination dose of IDE196 + crizotinib will be tested
药品：Darovasertib
Oral, selectively targets key proteins
药品：Crizotinib (Xalkori)
Oral small molecule
无干预：Observation
Participant Group/Arm: Observation Standard of care observation & follow-up (no treatment)

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Median relapse-free survival
大体时间：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)
Approximately 5 years

次要结果测量

结果测量
措施说明
大体时间
Median metastasis-free survival
大体时间：Approximately 5 years
Median MFS, defined as the time from randomization to the date of metastatic disease (outside of the eye or orbit) by BICR per RECIST v 1.1
Approximately 5 years
Overall survival
大体时间：Approximately 5 years
Overall survival with darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease who are at high-risk for recurrence
Approximately 5 years
Median UM specific survival
大体时间：Approximately 5 years
Median UM specific survival defined as the time from randomization to the date of death due to UM
Approximately 5 years
Median metastasis-free survival
大体时间：Approximately 5 years
Median MFS, defined as the time from randomization to the date of metastatic disease (outside of the eye or orbit) as assessed by investigator
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
大体时间：Approximately 3 years
To assess safety and tolerability of darovasertib + crizotinib in participants who have completed PLT for primary UM
Approximately 3 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)
大体时间：Approximately 5 years
Compare quality of life outcomes of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM
Approximately 5 years
Recurrence-free suvival
大体时间：Approximately 5 years
Compare RFS of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease and who are at high-risk for recurrence
Approximately 5 years
Metastasis-Free Survival
大体时间：Approximately 5 years
Compare MFS of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease and who are at high-risk for recurrence
Approximately 5 years
Median Local Recurrence-Free Survival
大体时间：Approximately 5 years
Compare local RFS (LRFS) of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease and who are at high-risk for recurrence
Approximately 5 years
Change from baseline over time and across Treatment Arms as measured by European Quality of Life Questionnaire EQ-5D-5L.
大体时间：[Time Frame: Approximately 5 years]
Compare quality of life outcomes of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM
[Time Frame: Approximately 5 years]
Change from baseline over time and across Treatment Arms as measured by EORTC Oncology Quality of Life Questionnaire Ophthalmic-30 (EORTC QLQ-OPT30)
大体时间：[Time Frame: Approximately 5 years]
Compare quality of life outcomes of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM
[Time Frame: Approximately 5 years]

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

IDEAYA Biosciences

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2034年3月1日

研究完成 (估计的)

2034年4月1日

研究注册日期

首次提交

2026年8月21日

首先提交符合 QC 标准的

2026年8月31日

首次发布 (实际的)

2026年9月4日

研究记录更新

最后更新发布 (实际的)

2026年9月15日

上次提交的符合 QC 标准的更新

2026年9月11日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IDE196-011

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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