Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 520
- 试验地点
- 504
- 主要终点
- Assess Progression-free survival (PFS)
研究概览
简要总结
GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and efficacy of mirvetuximab Soravtansine + Bevacizumab as maintenance therapy in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression.
详细描述
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRα). It is being developed as maintenance therapy for the treatment of subjects with recurrent platinum-sensitive, highgrade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. Patients must have confirmation of FRα positivity by the Ventana FOLR1 Assay.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women >/=18 years old
- •Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
- •Confirmed high FRα expression by regulatory-agency approved Ventana FOLR1 (FOLR1-2.1)
- •Relapsed disease after frontline (first-line) platinum-based chemotherapy and must be plantinum-sensitive
- •Willing and able to sign the informed consent form (ICF) and adhere to protocol requirements
- •Negative pregnancy test and willing to use highly effective contraceptive method(s) while on study medication and for at least 7 months after the last dose of MIRV and 6 months after the last dose of bevacizumab
排除标准
- •Endometrioid, clear cell, mucinous, or sarconmatous histology; mixed tumors containing any of the above or low grade/borderline ovarian tumor
- •More than one line of prior chemotherapy before current/planned triplet therapy
- •PD (progressive disease) while on or following platinum-based therapy
- •Prior or whole-pelvis or wide-field radiotherapy
- •> Grade 1 peripheral neuropathy
- •History of or concurrent ocular disorders
- •Grade 4 thromboembolic events
- •Not appropriate for bevacizumab treatment
- •Requiring use of folate-containing supplements
- •Prior hypersensitivity to monoclonal antibodies
- •Pregnant or breatfeeding women
- •Received prior MIRV or other FRα-targeting agents
- •Untreated or symptomatic central nervous system metastases
- •History of other malignancy within 3 years prior to signing study consent
研究组 & 干预措施
Arm 1
Mirvetuximab Soravtansine (MIRV) plus Bevacizumab
干预措施: Mirvetuximab soravtansine plus Bevacizumab (Drug)
Arm 2
Bevacizumab monotherapy
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Assess Progression-free survival (PFS)
时间窗: Up to 4 years
Progression-free survival defined as assessed by BICR per RECIST v1.1, defined as the time from date of randomization until BICR-assessed PD or death due to any cause, whichever occurs first
次要结局
- Assess Overall survival (OS)(Up to 10 years)
- Assess Safety and tolerability(Up to 10 years)
- Assess time to second disease progression (PFS2)(Up to 10 years)
- Assess Objective Response Rate (ORR)(Up to 10 years)
- Assess Duration of response (DOR)(Up to 10 years)
- Assess Disease-free survival (DFS)(Up to 10 years)
- CA-125 response(Up to 10 years)
- Patient-reported outcome health-related quality of life (HRQoL) of disease-related symptoms using the NCCN-FACT Ovarian Symptom Index (NFOSI-18) DRS-P (disease-related symptom subscale - physical).(Up to 10 years)