A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/GOG-3102)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 165
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include:
- Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread.
- Observation, which is watching to see if cancer grows or worsens
The study medicine, sacituzumab tirumotecan (also called sac-TMT), is a targeted therapy. The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.
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
- Single (Outcomes Assessor)
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
- •The main inclusion criteria include but are not limited to the following:
- •Has diagnosis of FIGO 2014 Stage III or Stage IV, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with one of the following histologies: high-grade serous, high-grade endometrioid, clear cell carcinoma, or malignant mixed Müllerian tumour with a high-grade serous component. Tumors reported as Grade 2 may be enrolled only if predominately (>50%) Grade 3 features are present.
- •Has completed primary debulking surgery or interval debulking surgery.
- •Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol.
- •Has provided tumor tissue that is not previously irradiated.
- •Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if diagnosed with HIV
- •Has undetectable hepatitis B virus (HBV) viral load and received HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.
- •Has undetectable hepatitis C virus (HCV) viral load if has a history of HCV infection.
排除标准
- •include but are not limited to the following:
- •Has nonepithelial cancers, low-grade serous tumors, low-grade endometrioid tumors, borderline tumors mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma.
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Has a history of severe eye disease.
- •Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease.
- •Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
- •Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD), which required steroids, has current pneumonitis/ILD, or has suspected ILD, or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening.
- •Received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria.
- •Had a live or live-attenuated vaccine within 30 days of randomization.
- •Has a known additional malignancy that is progressing or required active treatment within the past 3 years.
- •Has active infection requiring systemic therapy.
- •Has concurrent and active HBV and HCV infections.
- •Has HIV infection and a history of Kaposi's sarcoma and/or multicentric Castleman's disease.
- •Has not recovered from major surgery or has ongoing surgical complications.
- •Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory.
- •Active or ongoing stomatitis of any grade.
研究组 & 干预措施
Sac-TMT +/- Bevacizumab
Participants will receive sac-TMT on days 1, 15, and 29 (q2W) of every 6-week cycle, until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation. Participants receive optional bevacizumab at investigator's discretion on Days 1 and 22 (q3w) of every 6-week cycle, for up to 22 courses.
干预措施: Sacituzumab tirumotecan (Drug)
Sac-TMT +/- Bevacizumab
Participants will receive sac-TMT on days 1, 15, and 29 (q2W) of every 6-week cycle, until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation. Participants receive optional bevacizumab at investigator's discretion on Days 1 and 22 (q3w) of every 6-week cycle, for up to 22 courses.
干预措施: Bevacizumab (Drug)
Standard of Care
Participants will either receive bevacizumab q3w of every 6-week cycle for up to 22 courses until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention, or will be observed only and actively followed if not receiving bevacizumab.
干预措施: Bevacizumab (Drug)
Sac-TMT +/- Bevacizumab
Participants will receive sac-TMT on days 1, 15, and 29 (q2W) of every 6-week cycle, until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation. Participants receive optional bevacizumab at investigator's discretion on Days 1 and 22 (q3w) of every 6-week cycle, for up to 22 courses.
干预措施: Rescue Medications (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to approximately 49 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
次要结局
- Change From Baseline in Global Health Status/Quality of Life (GHS/QoL) Combined Score (Items 29 and 30) Using the European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30)(Baseline and up to approximately 78 months)
- Change From Baseline in Physical Functioning Combined Score (Items 1 to 5) Using EORTC QLQ-C30(Baseline and up to approximately 78 months)
- Change From Baseline in Role Functioning Combined Score (Items 6 and 7) Using EORTC QLQ-C30(Baseline and up to approximately 78 months)
- Change From Baseline in Abdominal/Gastrointestinal (GI) Symptoms Combined Score Using the EORTC QLQ-Ovarian Cancer Module 28 (OV28)(Baseline and up to approximately 78 months)
- Overall Survival (OS)(Up to approximately 78 months)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 78 months)
- Progression-Free Survival 2 (PFS2)(Up to approximately 78 months)
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 78 months)
- Change From Baseline in Global Health Status/Quality of Life (GHS/QoL) Combined Score (Items 29 and 30) Using the European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30)(Baseline, and at designated time points up to approximately 78 months)
- Change From Baseline in Physical Functioning Combined Score (Items 1 to 5) Using EORTC QLQ-C30(Baseline, and at designated time points up to approximately 78 months)
- Change From Baseline in Role Functioning Combined Score (Items 6 and 7) Using EORTC QLQ-C30(Baseline, and at designated time points up to approximately 78 months)
- Change From Baseline in Abdominal/Gastrointestinal (GI) Symptoms Combined Score Using the EORTC QLQ-Ovarian Cancer Module 28 (OV28)(Baseline, and at designated time points up to approximately 78 months)