2025-521606-18-00招募中2 期
A Phase 2, Open-Label, Randomized, Master Protocol Dose Optimization Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations with Mirvetuximab Soravtansine in Subjects with Ovarian Cancer (FLORENZA)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 5
- 主要终点
- Substudy 1 and 2: Number of Participants with TEAEs (any grade, Grade ≥ 3)
研究概览
简要总结
- To evaluate the safety, tolerability, and efficacy of MIRV in combination regimens in FRα positive ovarian cancer participants
- To optimize the MIRV dose in combination regimens to determine the recommended Phase 3 dose (RP3D) in applicable substudies
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Substudy 1 and 2: Participants must have an Eastern Cooperative Oncology Group performance status of 0 or
- •Substudy 1: Participants must have a confirmed diagnosis of FIGO Stage III or IV high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
- •Substudy 1: Tumor must be confirmed HRD test negative (HRP), determined by a local HRD test.
- •Substudy 2: Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
- •Substudy 2: Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.
- •Substudy 2: Participants must have platinum-sensitive disease defined as radiographic progression greater than 6 months from the last dose of platinum-based chemotherapy.
- •Substudy 2: Participants must have measurable disease per RECIST v1.1 (assessed by the investigator) at baseline.
排除标准
- •Substudy 1: Participants with PD while on triplet therapy or after the first day of their last triplet therapy cycle and before randomization.
- •Substudy 1: Participants who receive an intervening dose of bevacizumab after the first day of their last triplet therapy cycle and before randomization.
- •Substudy 2: More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations: • Neoadjuvant ± adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens. • Maintenance therapy (e.g., bevacizumab, PARP inhibitor) will be considered part of the preceding line of therapy (i.e., not counted independently). • If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the proceeding line of therapy • Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen)
- •Substudy 1 and 2: Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.
结局指标
主要结局
Substudy 1 and 2: Number of Participants with TEAEs (any grade, Grade ≥ 3)
Substudy 1 and 2: Number of Participants with TEAEs (any grade, Grade ≥ 3)
Substudy 1 and 2: Number of Participants with TEAEs leading to discontinuation
Substudy 1 and 2: Number of Participants with TEAEs leading to discontinuation
Substudy 1 and 2: Number of Participants with Ocular AEs (any grade, Grade ≥ 2)
Substudy 1 and 2: Number of Participants with Ocular AEs (any grade, Grade ≥ 2)
Substudy 1 and 2: Overall Response (OR) as assessed by the investigator per RECIST v1.1
Substudy 1 and 2: Overall Response (OR) as assessed by the investigator per RECIST v1.1
Substudy 1: Progression free survival (PFS) as assessed by the investigator per RECIST v1.1
Substudy 1: Progression free survival (PFS) as assessed by the investigator per RECIST v1.1
次要结局
- Substudy 1 and 2: CA-125 response per Gynecologic Cancer Intergroup (GCIG) Criteria
- Substudy 1 and 2: Duration of Response (DOR) as assessed by the investigator per RECIST v1.1
- Substudy 1 and 2: Number of Participants with Peripheral neuropathy AEs (any grade, Grade ≥ 2)
- Substudy 1 and 2: Number of Participants with Pneumonitis/ Interstitial Lung Disease (ILD) (any grade)
- Substudy 2: PFS as assessed by the investigator per RECIST v1.1
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (5)
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