2023-508015-23-00招募中3 期
A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) 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)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 73
- 主要终点
- Part 1: Number of Participants with One or More Adverse Events (AE)
研究概览
简要总结
-
Part 1: To evaluate the safety and tolerability of sacituzumab tirumotecan maintenance treatment with bevacizumab
-
Part 2: 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
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
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 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 CNS metastases and/or carcinomatous meningitis
- •Has an active infection requiring systemic therapy
- •Has platinum-resistant OC or platinum-refractory OC
- •Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- •Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, 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)
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Part 1: Number of Participants with One or More Adverse Events (AE)
Part 1: Number of Participants with One or More Adverse Events (AE)
Part 1: Number of Participants who Discontinue Study Intervention Due to an AE
Part 1: Number of Participants who Discontinue Study Intervention Due to an AE
Part 2: Progression-free Survival (PFS)
Part 2: Progression-free Survival (PFS)
次要结局
- Part 2: Overall Survival (OS)
- Part 2: Number of Participants with One or More AEs
- Part 2: Number of Participants who Discontinue Study Intervention Due to an AE
- Part 2: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status-Quality of Life Score
- Part 2: Change from Baseline in EORTC QLQ-C30 Physical Functioning Score
- Part 2: Change from Baseline in EORTC QLQ-C30 Role Functioning Score
- Part 2: Change from Baseline in EORTC Quality of Life Questionnaire-Ovarian Cancer Module 28 Abdominal/Gastrointestinal Symptom Scale
研究者
Matt Horn
Scientific
Merck Sharp & Dohme LLC
研究点 (73)
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