A Phase 2 Open-label Randomized Study of Farletuzumab Ecteribulin (MORAb-202), a Folate Receptor Alpha-targeting Antibody-drug Conjugate, Versus Investigator's Choice Chemotherapy in Women With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 100
- 主要终点
- Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment
研究概览
简要总结
The purpose of the study is to assess the safety, tolerability, and efficacy of farletuzumab ecteribulin (MORAb-202) and compare it to Investigator's choice (IC) chemotherapy in female participants with platinum-resistant HGS ovarian, primary peritoneal, or fallopian tube cancer.
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
- •Female participants with histologically-confirmed diagnosis of HGS ovarian, primary peritoneal, or fallopian tube cancer.
- •Platinum-resistant disease, defined as:
- •For participants who had only 1 line of platinum-based therapy: progression between > 1 month and ≤ 6 months after the last dose of platinum-based therapy of at least 4 cycles.
- •For participants who had 2 or 3 lines of platinum-based therapy: progression ≤ 6 months after the last dose of platinum-based therapy.
- •Participants have received at least 1 but no more than 3 prior lines of systemic therapy and for whom single-agent therapy is appropriate as the next line of therapy. Participants may have been treated with up to 1 line of therapy subsequent to determination of platinum-resistance.
- •Disease progression per RECIST v1.1 (by investigator assessment) of at least 1 measurable lesion on or after the most recent therapy.
- •Either formalin-fixed, paraffin-embedded (FFPE) tissue (up to 5 years old) or newly-obtained biopsies must be available for FRα assessment prior to randomization.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
排除标准
- •Medical Conditions
- •Clear cell, mucinous, endometrioid or sarcomatous histology, or mixed tumors containing components of any of these histologies, or low grade or borderline ovarian cancer.
- •Primary platinum-refractory ovarian cancer defined as disease progression within 1 month of the last dose of the first line platinum-containing regimen.
- •Pulmonary function test (PFT) abnormalities: FEV1 < 70% or FVC < 60%, and DLCO < 80%.
- •Investigator-assessed current ILD/pneumonitis, or ILD/pneumonitis suspected at screening or history of ILD/pneumonitis of any severity including ILD/pneumonitis from prior anti-cancer therapy.
- •Significant third-space fluid retention (eg, ascites or pleural effusion) that requires repeated drainage.
- •Physical and Laboratory Test Findings
- •Evidence of organ dysfunction or any clinically-significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population.
- •Allergies and Adverse Drug Reactions
- •Has any prior severe hypersensitivity (≥ Grade 3) to monoclonal antibodies or eribulin or contraindication to the receipt of corticosteroids or any of the excipients (investigators should refer to the prescribing information for the selected corticosteroid).
- •History of allergy or contraindication to IC chemotherapy agent selected if randomized to Arm C.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
MORAb-202
干预措施: MORAb-202 (Drug)
Investigator's Choice Chemotherapy
干预措施: Pegylated Liposomal Doxorubicin (PLD) (Drug)
Investigator's Choice Chemotherapy
干预措施: Paclitaxel (Drug)
Investigator's Choice Chemotherapy
干预措施: Topotecan (Drug)
结局指标
主要结局
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment
时间窗: From the date of randomization to the date of first objectively-documented progression or the date of subsequent therapy (Up to approximately 70 weeks)
Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on investigator assessments \[using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\], divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Number of Participants With Treatment-Related Adverse Event (TRAEs) Leading to Discontinuation Within 6 Months From First Dose
时间窗: From first dose of study medication up to 6 months
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.
次要结局
- Number of Participants With Adverse Events (AEs)(From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months))
- Number of Participants With AEs Leading to Discontinuation(From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months))
- Number of Participants With Treatment-Related AEs(From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months))
- Number of Participants Who Died(From first dose of study medication until death due to any cause (up to 70 weeks))
- Number of Participants With Serious Adverse Events (SAEs)(From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months))
- Number of Participants With AEs of Special Interest (AESIs)(From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months))
- Disease Control Rate (DCR) by RECIST v1.1 Per Investigator Assessment(From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks))
- Number of Participants With Treatment-Related SAEs(From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months))
- Number of Participants With Grade 3-4 Laboratory Abnormalities(From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months))
- Duration of Response (DoR) by RECIST v1.1 Per Investigator Assessment(From the date of first dose to the date of the first documented tumor progression, or death, whichever occurs first (Up to approximately 70 weeks))
- Progression-free Survival (PFS) by RECIST v1.1 Per Investigator Assessment(From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks))