EUCTR2018-000366-11-FR进行中（未招募）1 期
A phase III randomized, double-blinded trial of platinum-based chemotherapy with or without atezolizumab followed by niraparib maintenance with or without atezolizumab in patients with recurrent ovarian, tubal or peritoneal cancer and platinum treatment-free interval (TFIp) >6 months. - ANITA
Grupo Español de Investigación en Cáncer de Ovario (GEICO)0 个研究点目标入组 414 人开始时间: 2019年11月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 414
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Patients = 18 years old
- •2. Life expectancy =3 months
- •3. Signed informed consent and ability to comply with treatment and follow-up
- •4. Histologically confirmed diagnosis (cytology alone excluded) of high- grade serous or endometrioid ovarian, primary peritoneal or tubal carcinoma. In addition, mixed histologies with predominat high grade serous or endometrioid, or undifferentiated adenocarcinoma of the ovary are allowed
- •5. BRCA mutational status is known (germline or somatic)
- •6. Relapsed disease more than 6 months after the last platinum dose:
- •7. No more than 2 prior lines of chemotherapy are allowed, and the last one must contain a platinum-based regimen
- •8. At least one measurable lesion to assess response by RECIST v1.1 criteria.
- •9. Mandatory de novo tumor biopsy (collected within 3mths prior to randomization) sent to central laboratory as a FFPE sample for PD-L1 status determination for randomization
- •10. Two additional tumour samples are needed. Archival tumor sample must be available for exploratory PD-L1 testing in archival tissue and archival or fresh tissue sample for biomarkers must also be available.
- •11. Performance status determined by ECOG score of 0-1
- •12. Patients must have normal organ and bone marrow function:
- •- Haemoglobin =10.0 g/dL
- •- Absolute neutrophil count (ANC) =1.5 x 109/L
- •- Lymphocyte count =0.5 × 109/L
- •- Platelet count =100 x 109/L
- •- Total bilirubin =1.5 x institutional upper limit of normal (ULN)
- •- Serum albumin =2.5 g/dL
- •- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =2.5 x ULN, unless liver metastases are present in which case they must be =5 x ULN
- •- Serum creatinine =1.5 x institutional ULN or calculated creatinine clearance = 30 mL/min using the Cockcroft-Gault equation
- •- Patients not receiving anticoagulant medication must have an International Normalized Ratio (INR) =1.5 and an Activated ProThrombin Time (aPTT) =1.5 x ULN.
- •13. Negative Test Results for Hepatitis
- •14. Toxicities related to previous treatments must be recovered to < grade 2 (with the exception of alopecia)
- •15. Female participants must be postmenopausal (= 12 months of non-therapy-induced amenorrhoea; patients who have been amenorrhoeic for <2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation) or surgically sterile (absence of ovaries and/or uterus, or who received therapeutic radiation to the pelvis) or otherwise have a negative serum pregnancy test within 7 days of the first study treatment and agree to abstain from heterosexual intercourse or use single or combined contraceptive methods that result in a failure rate of <1% per year during the whole treatment period of the study and for at least 180 days after the last dose of study treatment. Women must refrain from donating eggs during this same period
- •16. Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
- •17. Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 354
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1.Non-epithelial tumor of the ovary, the fallopian tube or the peritoneum
- •2.Ovarian tumors of low malignant potential or low grade
- •3.Other malignancy within the last 5 years except curatively treated non-melanoma skin cancer, in situ cancer of the cervix and ductal carcinoma in situ (DCIS)
- •4.Major surgery or patients who have not completely recovered from the effects of any major surgery at randomization
- •5.Core biopsy or other minor surgical procedure.
- •6.Administration of other CT drugs, anticancer therapy or anti-neoplastic hormonal therapy, or TTT with other investigational agents or devices
- •7.Palliative radiotherapy
- •8.Current or recent chronic use of aspirin or clopidogrel
- •9.Clinically significant cardiovascular disease
- •10.Resting ECG with QTc >470 msec on 2 or more time points within a 24 h period or family history of long QT syndrom
- •11.LVEF defined by MUGA/ECHO below the institutional lower limit of normal
- •12.History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory in case of suspected brain metastases
- •13.History or evidence upon neurological examination of central nervous system (CNS) disorders
- •14.Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease
- •15.Uncontrolled tumor-related pain
- •16.Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- •17.Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
- •18.Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for TTT related complications
- •19.Pregnant or lactating women. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study TTT
- •20.Simultaneously receiving therapy in any interventional clinical trial.
- •21.Prior treatment with CD137 agonists or immune checkpoint stimulating or blockade therapies, such as anti-PD1, anti-PDL1 or anti-CTLA4 therapeutic antibodies
- •22.Treatment with systemic immunostimulatory agents
- •23.Treatment with systemic corticosteroids or other systemic immunosuppressive medications
- •24.History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrom, Guillain-Barré syndrom, multiple sclerosis, vasculitis, or glomerulonephritis.
- •25.History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis.
- •26.Immunocompromised patients, e.g., patients who are known to be serologically positive for HIV
- •27.Signs or symptoms of infection within 4 wks prior to Cycle 1, Day 1
- •28.Active Tuberculosis
- •29.Administration of a live, attenuated vaccine or anticipation that it will be administered at any time during the treatment period of the study or within 5 months after the final dose of atezolizumab
- •30.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •31.Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hams
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