2022-501606-35-01
招募中
Phase III and phase IV (Integrated)
2022-501606-35-00 – 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 (GLORIOSA).
Immunogen Biopharma (Ireland) Limited, Immunogen Inc.85 个研究点 分布在 9 个国家目标入组 110 人开始时间: 2023年11月6日最近更新:
概览
- 阶段
- Phase III and phase IV (Integrated)
- 状态
- 招募中
- 发起方
- Immunogen Biopharma (Ireland) Limited, Immunogen Inc.
- 入组人数
- 110
- 试验地点
- 85
- 主要终点
- PFS, 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. PFS as assessed by the investigator, as a sensitivity analysis, in the same patient population
概览
简要总结
To compare progression-free survival (PFS), as assessed by a blinded independent central review (BICR) per the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), in patients who have not progressed after platinum-based chemotherapy (doublet) plus bevacizumab and who are randomized to maintenance mirvetuximab soravtansine (MIRV) plus bevacizumab (Arm 1) or bevacizumab alone (Arm 2) -PFS will also be assessed, as a sensitivity analysis, by the investigator in the same patient population
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Treatment
- 盲法
- None
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
- 是
入选标准
- •Patients must be ≥ 18 years of age and ≥ age of majority
- •Females of childbearing potential (FCBP) must agree to use highly effective contraceptive method(s) (as defined in Section 5.10.7) while on study medication during the study and for at least 7 months after the last dose of MIRV and 6 months after the last dose of bevacizumab.
- •FCBP must have a negative pregnancy test within 4 days before the first dose of therapy.
- •Patients must have an Eastern Cooperative Oncology Group performance status of 0 or
- •Patients must have a confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
- •Patients must be willing to provide documentation of a positive high tumor FRα expression. This may be obtained either via results from the regulatory agency-approved Ventana FOLR1 (FOLR1-2.1) Assay or via tissue testing by the study tissue testing laboratory. Patients undergoing pre-screening must provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of high FRα expression (reported as “positive”) as defined by the Ventana FOLR1 (FOLR1-2.1) Assay in a tissue testing laboratory. Patients must be confirmed FRα-high as defined by FRα positivity of ≥ 75% of tumor membrane staining at ≥ 2+ intensity (PS2+) for entry into the study. Note: Samples may be submitted for central testing as soon as patients pass the 6-month time point for platinum sensitivity (ie, sites do not have to wait for recurrence to determine FRα expression status).
- •Where available as standard of care, prior testing on the tumor or prior germline testing of both BRCA1 and BRCA2 is required for eligibility. If not done prior, tumor or germline testing will need to be done before study entry. Somatic or germline BRCA-positive patients must have received prior treatment with a PARPi in maintenance following first-line treatment unless documented as clinically contraindicated. Note: Local tumor or germline BRCA testing will be acceptable for stratification. If the patient has not been tested, recommend archival tumor samples to be assessed for tissue BRCA. Prior PARPi and/or bevacizumab use during first line maintenance therapy is allowed but not required.
- •Patients’ disease must have relapsed after frontline (first line) platinum-based chemotherapy and must be platinum-sensitive defined as progression greater than 6 months from last dose of primary platinum therapy. Note: Bevacizumab treatment is allowed, but not required, in frontline regimen. HIPEC is allowed in frontline regimen.
- •Patients must be appropriate for platinum-based triplet therapy for treatment of their first recurrence of PSOC (entering at Run-In phase) or undergoing or have completed triplet therapy for treatment of their first recurrence of PSOC (entering at maintenance phase).
- •Patients must have received no less than 4 and no greater than 8 cycles of platinum-based triplet therapy in the second line, to include no less than 3 cycles of bevacizumab in combination with platinum-based chemotherapy. If the number of cycles received is less than 6 due to toxicity, this must be documented and toxicity assessed as unlikely related to bevacizumab. Note: A minimum of 4 cycles of combination chemotherapy is required. If carboplatin (or cisplatin), paclitaxel, gemcitabine, or pegylated liposomal doxorubicin (PLD) is stopped due to toxicity, up to 4 additional cycles of single agent in combination with bevacizumab is acceptable if appropriately documented.
排除标准
- •Patients with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade/borderline ovarian tumor
- •Patients with clinically significant cardiac disease including, but not limited to, any of the following: a. Myocardial infarction ≤ 6 months prior to C1D1 of maintenance treatment b. Unstable angina pectoris c. Uncontrolled congestive heart failure (New York Heart Association > class II) d. Uncontrolled ≥ Grade 3 hypertension (per CTCAE) e. Uncontrolled cardiac arrhythmias
- •Patients with a history of hemorrhagic or ischemic stroke within 6 months before enrollment
- •Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)
- •Patients with a previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis (exception: Grade 1 noninfectious pneumonitis diagnosed on or within 6 weeks after treatment with an immunotherapeutic agent used in the treatment of their malignancy that has resolved per investigator or resolution of the radiologic findings)
- •History of bowel obstruction (including sub-occlusive disease) related to underlying disease within 6 months before the start of maintenance study treatment (triplet therapy for Run-In patients)
- •History of abdominal fistula or gastrointestinal perforation
- •Intra-abdominal abscess, evidence of rectosigmoid involvement by pelvic examination, bowel involvement on CT scan, or clinical symptoms of bowel obstruction within 4 weeks prior to randomization (or within 4 weeks prior to starting triplet therapy for Run- In patients)
- •Clinically significant proteinuria: urine-protein to creatinine (UPC) ratio ≥ 1.0 or urine dipstick result ≥ 2+; patients with UPC ratio ≥ 1.0 or ≥ 2+ proteinuria should undergo 24- hour urine collection and must show result ≤ 2 g of protein in a 24-hour period
- •History of Grade 4 thromboembolic events
结局指标
主要结局
PFS, 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. PFS as assessed by the investigator, as a sensitivity analysis, in the same patient population
PFS, 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. PFS as assessed by the investigator, as a sensitivity analysis, in the same patient population
次要结局
- CA-125 response rate per GCIG criteria
- HRQoL/PRO measured by NFOSI-18 DRS-P
- OS defined as the time from randomization to death due to any cause. Patients alive at the time of analysis will be censored at the last date known to be alive.
- Treatment-emergent adverse events (TEAEs) and laboratory test results, physical examination (PE) findings, and vital signs
- PFS2 as assessed by the investigator, defined as the time from date of randomization until second disease progression or death due to any cause, whichever occurs first
- ORR as assessed by the investigator and by BICR in patients who have measurable disease per RECIST v1.1 at randomization
- DOR as assessed by the investigator and by BICR in patients who have measurable disease per RECIST v1.1 at randomization and achieved a confirmed response of CR or PR after maintenance therapy
- DFS as assessed by the investigator and by BICR in patients who have no measurable disease per RECIST v1.1 at randomization
研究者
Global Clinical Trials Helpdesk
Scientific
Immunogen Inc.
研究点 (85)
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