2024-519404-27-00
尚未招募
3 期
EORTC-2427-BTG: Vorasidenib as maintenance treatment after first-line chemoradiotherapy in IDH-mutant grade 2 or 3 astrocytoma: a placebo-controlled, triple-blind, randomized phase III study (VIGOR)
Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi27 个研究点 分布在 8 个国家目标入组 247 人开始时间: 2025年11月4日最近更新:
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi
- 入组人数
- 247
- 试验地点
- 27
- 主要终点
- The primary endpoint is PFS, as assessed locally from the date of enrolment using the RANO 2.0 criteria.
概览
简要总结
In this phase III study, the main goal is to demonstrate that vorasidenib maintenance therapy improves locally assessed PFS from enrolment compared to placebo in patients with IDH-mutant, CNS5 WHO grade 2 or 3 astrocytoma following the completion of first-line chemoradiotherapy
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Informed consent
- •Stable or decreasing corticosteroid dose, or no use of corticoids, for at least 7 days prior to enrolment.
- •Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within two weeks prior to enrolment; a serum or urine pregnancy test must be conducted and confirmed negative within 72 hours prior to the first dose of study treatment.
- •Participants of childbearing / reproductive potential should use two adequate methods of birth control, including a highly effective method and a barrier method during the study treatment period and for at least 90 days after the last dose of treatment.
- •Age ≥ 18 years
- •Integrated diagnosis of astrocytoma, IDH-mutant, CNS5 WHO grade 2 or 3, per local assessment, with documented IDH1 or IDH2 mutation based on local testing of tumour tissue.
- •At least 1 prior surgery for glioma.
- •Completed first-line standard of care radiotherapy (minimum 50.4 Gy, photons or protons allowed) followed by SoC adjuvant chemotherapy (i.e., either 4-12 cycles of temozolomide or 2-6 cycles of PCV).
- •Last chemotherapy dose of first line chemoradiotherapy more than 6 weeks and less than 12 weeks before enrolment.
- •Recovered from any clinically relevant toxicity of the previous chemoradiotherapy unless stable and manageable per investigator´s judgement
排除标准
- •Presence of 1p19q co-deletion, per local assessment.
- •Tumour recurrence or progression per RANO 2.0 criteria between first day of radiotherapy and enrolment, per local assessment
- •Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- •Integrated diagnosis of astrocytoma, IDH-mutated, CNS5 WHO grade 4
- •Ongoing use of medications that are CYP2C8, CYP2C9, CYP2C19, or CYP3A substrates with a narrow therapeutic index. Participants must be transferred to other medications before receiving the first dose of study drug
结局指标
主要结局
The primary endpoint is PFS, as assessed locally from the date of enrolment using the RANO 2.0 criteria.
The primary endpoint is PFS, as assessed locally from the date of enrolment using the RANO 2.0 criteria.
次要结局
- PFS by retrospective central radiological assessment from the date of enrolment using the RANO 2.0 criteria.
- PFS from the start of radiotherapy (both local and retrospective central radiological assessment) using RANO 2.0 criteria.
- OS from date of enrolment.
- Best response, overall response, disease control and complete response rate (both local and retrospective central radiological assessment) as well as duration of response using RANO 2.0 criteria.
- TTNI
- Safety according to the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.
- HRQoL will be assessed
- Neurological symptoms and signs, assessed using the NANO scale and measured by neurological progression-free survival (NPFS) and Seizure Control Composite Score Index.
- Neurocognitive function, as assessed by a test battery consisting of HVLT-R, TMT, COWA test, and MOS scale
研究者
Stéphanie Kromar
Scientific
Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi
研究点 (27)
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