jRCT2031240722招募中不适用
A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer(TroFuse-022/ENGOT-ov84/GOG-3103)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- MSD K.K.
- 入组人数
- 38
- 主要终点
- Safety and tolerability
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- Female
入选标准
- •Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- •Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC).
- •Has platinum-sensitive epithelial OC.
- •Has provided tissue of a tumor lesion that was not previously irradiated.
- •Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
- •Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2).
- •Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
- •Has an ECOG performance status of 0 to 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2).
排除标准
- •Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma.
- •Has platinum-resistant OC or platinum-refractory OC.
- •Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
- •Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea).
- •Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
- •Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- •HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- •Has received more than 2 prior lines of systemic therapy for OC.
- •Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2).
- •Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids.
- •Has an additional malignancy that is progressing or has required active treatment within the past 3 years.
- •Has active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Has an active infection requiring systemic therapy.
结局指标
主要结局
Safety and tolerability
To evaluate the safety and tolerability of sacituzumab tirumotecan maintenance treatment with bevacizumab.
Progression-free survival (PFS)
To compare sacituzumab tirumotecan maintenance treatment with or without bevacizumab to SoC (observation with or without bevacizumab) with respect to PFS per RECIST 1.1 as assessed by BICR.
次要结局
- Abdominal/GI symptoms
- OS
- Safety and tolerability
- Global health status/QoL score
研究者
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