NCT07797283尚未招募3 期
A Phase 3, Double-Blind, Randomized, Controlled Study of INCB123667 in Combination With Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Participants With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Overexpressing Cyclin E1 (MAESTRA 3)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 590
- 主要终点
- Progression-Free Survival (PFS) by BICR
研究概览
简要总结
The purpose of this study is to evaluate INCB123667 in Combination With Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Participants With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Overexpressing Cyclin E1.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Newly diagnosed, histologically confirmed, FIGO Stage III or IV, high-grade serous, high-grade endometrioid, or clear cell ovarian, fallopian tube, or primary peritoneal cancer.
- •Underwent debulking surgery prior to randomization (either PDS or IDS).
- •Completed first-line platinum-based chemotherapy in combination with bevacizumab prior to randomization.
- •Received a minimum of 6 cycles (and no more than 8 cycles) of platinum-taxane chemotherapy.
- •Received at least 2 infusions of bevacizumab concurrently with the last 2 to 3 cycles of chemotherapy.
- •No clinical evidence of disease recurrence (ie, NED following surgery) or progression (ie, CR/PR/SD per RECIST v1.1) on completion of platinum-based chemotherapy.
- •Tumor overexpresses cyclin E
- •Has a local HRD (positive or negative) or BRCA test result available. Participants with BRCA wild-type must have a local HRD result based on a validated test.
- •ECOG performance status of 0 or 1.
排除标准
- •Ovarian, fallopian tube, or peritoneal cancer of nonepithelial origin or low-grade ovarian cancer.
- •Deleterious tumor BRCA mutation per local test.
- •Eligible for treatment with a PARPi as maintenance therapy.
- •Known additional malignancy that progressed or requires active treatment, or history of other malignancy within 3 years prior to randomization.
- •History of any clinically significant or uncontrolled cardiovascular disease within 6 months prior to randomization.
- •Clinically significant gastrointestinal abnormality.
- •History of thromboembolism and having been on therapeutic anticoagulation for less than 2 weeks prior to randomization.
- •Current treatment with any strong CYP3A4/CYP3A5 inhibitor or inducer or treatment with a strong CYP3A4/CYP3A5 inhibitor or inducer within 5 half-lives or 28 days (whichever is shorter) prior to randomization.
- •Exclusionary Laboratory Values:
- •Platelets: < 100 × 109/L
- •Hemoglobin: < 9 g/dL or < 5.6 mmol/L
- •ANC: < 1.5 × 109/L
- •ALT: ≥ 2.5 × ULN or ≥ 5 × ULN for participants with liver metastases
- •AST: ≥ 2.5 × ULN or ≥ 5 × ULN for participants with liver metastases
- •Total bilirubin: ≥ 1.5 × ULN
- •Albumin: < 2.5 g/dL
- •Calculated CrCl: < 45 mL/min
- •Protein in urine: Urine dipstick for proteinuria ≥ 2+
- •Other protocol-defined Inclusion/Exclusion Criteria may apply.
研究组 & 干预措施
Treatment Group A (TGA)
Experimental
Bevacizumab plus INCB123667 at the protocol defined dose.
干预措施: INCB123667 (Drug)
Treatment Group A (TGA)
Experimental
Bevacizumab plus INCB123667 at the protocol defined dose.
干预措施: Bevacizumab (Drug)
Treatment Group B (TGB)
Experimental
Bevacizumab plus matching placebo at the protocol defined dose.
干预措施: Placebo (Drug)
Treatment Group B (TGB)
Experimental
Bevacizumab plus matching placebo at the protocol defined dose.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) by BICR
时间窗: Up to approximately 5 years
Defined as the time from randomization until the first documented disease progression or disease recurrence as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first.
次要结局
- Overall Survival (OS)(Up to approximately 7 years)
- Progression-Free Survival (PFS) by investigator(Up to approximately 5 years)
- Progression-Free Survival on the First Subsequent Therapy (PFS2)(Up to approximately 7 years)
- Second Progression-Free Survival (PFS)(Up to approximately 7 years)
- Time to First Subsequent Therapy (TFST)(Up to approximately 7 years)
- Time to Second Subsequent Therapy (TSST)(Up to approximately 7 years)
- Treatment Emergent Adverse Events (TEAEs)(Up to approximately 13 months)
- TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment(Up to approximately 13 months)
- Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at each postbaseline visit(Up to approximately 5 years)
- Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) -Ovarian Cancer 28 (OV28) score at each postbaseline visit(Up to approximately 5 years)
- Change from baseline in EQ-5D-5L score at each postbaseline visit(Up to approximately 5 years)
研究者
相似试验
进行中（未招募）
4 期
Efficacy and Regimen of Bevacizumab Augmentation in Glaucoma Surgeries: A Randomized Clinical Trial across Trabeculectomy, Glaucoma Drainage Device, MIBS at Mettapracharak Hospital (Wat Rai khing)Bevacizumab, Filtering Surgery, Minimally Invasive Surgical Procedures, Trabeculectomy, Glaucoma Drainage Implants, administration &dosage, therapeutic useglaucomaTCTR20260721004Mettapracharak hospital (Wat Rai Khing)160
尚未招募
不适用
Low-Dose Bevacizumab and Atezolizumab Combined With TACE-HAIC in Unresectable Hepatocellular CarcinomaHepatocellular CarcinomaAtezolizumab Plus BevacizumabTransarterial ChemoembolizationNCT07543510Third Affiliated Hospital, Sun Yat-Sen University38
尚未招募
2 期
To Evaluate the Efficacy and Safety of JPI-547 in Combination With Bevacizumab as Maintenance Therapy in Relapsed Ovarian CancerOvarian CancerNCT07370818Onconic Therapeutics Inc.81
已完成
2 期
Bevacizumab Plus Nab-paclitaxel and Tegafur Gimeracil Oteracil Potassium Capsule (S-1) as Second-line Treatment for Advanced Biliary Tract Cancer: a Phase Ⅱ Clinical TrialBiliary Cancer MetastaticNCT07719738Cancer Institute and Hospital, Chinese Academy of Medical Sciences32
招募中
3 期
A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence2023-507689-26-00Astrazeneca AB94