A Randomized Study of Paclitaxel – Carboplatin followed by maintenance Niraparib compared to Paclitaxel – Carboplatin – Bevacizumab followed by maintenance Niraparib + Bevacizumab in Patients With Advanced Ovarian Cancer Following a Front-Line Complete Cytoreductive Surgery (NIRVANA-1 study)

Arcagy Gineco72 个研究点分布在 3 个国家目标入组 336 人2024年6月25日

概览

阶段: 2 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Arcagy Gineco
入组人数: 336
试验地点: 72
主要终点: Progression-Free Survival (PFS) is defined as time from randomization until objective tumor progression or death, whichever occurs first.
状态: 招募中
最后更新: 去年

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

Determine whether paclitaxel – carboplatin followed by maintenance with niraparib compared to paclitaxel – carboplatin – Bevacizumab followed by maintenance Niraparib + Bevacizumab following a Front- Line Complete Cytoreductive Surgery improves the progression-free survival rate at 24 months in patients with advance ovarian cancer, primary peritoneal cancer and/or fallopian-tube cancer.

注册库

euclinicaltrials.eu

开始日期

2024年6月25日

结束日期

待定

最后更新

去年

研究类型

Interventional clinical trial of medicinal product

性别

Female

研究者

发起方

Arcagy Gineco

责任方

Principal Investigator

主要研究者

Gilles Freyer

Scientific

Arcagy Gineco

入排标准

入选标准

•Female patient ≥ 18 years of age.
•Patient eligible for bevacizumab treatment in combination with chemotherapy and in maintenance. It must be started at the second chemotherapy cycle and be administered at a dose of 15mg/kg every 3 weeks up to a total of 15 months.
•Patient must have normal organ and bone marrow function before first cycle of chemotherapy: • Hemoglobin ≥ 9.0 g/dL. • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. • Platelet count ≥ 100 x 109/L. • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). • Aspartate aminotransferase/Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN. • Serum creatinine ≤
•5 x institutional ULN and GFR > 50 mL/min, by using an exact measure (ie. Iohexol clearance) or the most appropriate formula (Jeliffe, Cockroft Gault, MDRD, CKD-EPI) to the investigator’s discretion. GINECO-OV129b / ENGOT-OV63 / EUDRACT 2021-004278-76 – NIRVANA-1 – Protocol - Version 2.0 – 30/03/2022 (From FORM 113-02 : Protocol – Application date : 22/JUN/2020) Page 7 on 96 • Patient not receiving anticoagulant medication who has an International Normalized Ratio (INR) ≥1.5 and a Partial Thromboplastin Time (PTT) or an activated PTT (aPTT) ≥1.5 x ULN. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or the PTT or aPTT is within therapeutic limits (according to site medical standard). If the patient is on oral anticoagulants, dose has to be stable for at least two weeks at the time of randomization.
•Urine dipstick for proteinuria < 2+. If urine dipstick is ≥2+, 24-hour proteinuria must be <1 g.
•Normal blood pressure or adequately treated and controlled hypertension (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg).
•Formalin fixed paraffin embedded (FFPE) tumor sample from the primary cancer must be available for local BRCA testing and if possible HRD testing (optional).
•For countries where this will apply to: a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of a social security category.
•Signed informed consent and ability to comply with treatment and follow-up.
•Patient with newly diagnosed, a. Ovarian cancer, primary peritoneal cancer and/or GINECO-OV129b / ENGOT-OV63 / EUDRACT 2021-004278-76 – NIRVANA-1 – Protocol - Version 2.0 – 30/03/2022 (From FORM 113-02 : Protocol – Application date : 22/JUN/2020) Page 6 on 96 fallopian-tube cancer, b. Histologically confirmed (based on local histopathological findings): • high grade serous or • high grade endometrioid (grade 2 and 3) or • other epithelial non mucinous and non-clear cell ovarian cancer in a patient with germline BRCA 1 or 2 deleterious mutation, c. At an advanced stage: FIGO stage IIIA to IIIC of the 2018 FIGO classification.

排除标准

•Patient with clear cell adenocarcinoma or carcinosarcoma, non-epithelial origin of the ovarian tumor, the fallopian tube or the peritoneal tumor (i.e. germ cell tumors).
•Current or recent (within 10 days prior to randomization) chronic use of aspirin > 325 mg/day.
•Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy.
•Clinically significant (e.g. active) cardiovascular disease, including: • Myocardial infarction or unstable angina within ≤ 6 months of randomization, • New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF), • Poorly controlled cardiac arrhythmia despite medication (patient with rate controlled atrial fibrillation are eligible), or any clinically significant abnormal finding on resting ECG. • Peripheral vascular disease grade ≥ 3 (e.g. symptomatic and interfering with activities of daily living [ADL] requiring repair or revision).
•Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA), Sub- Arachnoids Hemorrhage (SAH) or Posterior Reversible Encephalopathy Syndrome (PRES).
•History or evidence of hemorrhagic disorders.
•Evidence of bleeding diathesis or significant coagulopathy (in the absence of coagulation).
•History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression.
•History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).
•Significant traumatic injury during 4 weeks prior to randomization.

结局指标

主要结局

Progression-Free Survival (PFS) is defined as time from randomization until objective tumor progression or death, whichever occurs first.

次要结局

Progression Free Survival (PFS)
Progression Free Survival 2 (PFS2)
Safety (assessed based on CTCAE version 5)
Time to First Subsequent Treatment (TFST)
Time to Second Subsequent Treatment (TSST)
Overall survival (OS) at 5 years
Confirm the predictive value (overall chemo-sensitivity) of the KELIM (CA-125 Elimination rate constant K)