EUCTR2018-000366-11-DE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 90 人开始时间: 2019年11月27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
- 90
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 3 months prior to randomization) for PD-L1 status determination for randomization. The inclusion of patients with non informative tissue PD-L1 status will be capped to 10% of the whole study population:
- •-If the mandatory de novo biopsy is technically not possible or failed to produce enough representative tumor tissue, a FFPE sample from archival tissue may be acceptable after approval of the sponsor.
- •-Bone metastases, fine needle aspiration, brushing, cell pellet from pleural effusion, or ascites or lavage are not acceptable.
- •10. Two additional tumour samples are needed: Archival tumor sample for exploratory PD-L1 testing in archival tissue and archival or ”de novo” tissue sample for biomarkers.
- •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. Examples of contraceptive methods with a failure rate of <1% per year include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (in-travaginal, transdermal*), progestogen-only hormonal contraception associated with inhibition of ovulation (injectable, implantable*), intrauterine device (IUD), intrauterine hormone-releasing sys-tem (IUS), bilateral tubal occlusion/ligation, vasectomized partner, sexual abstinence.
- •*Due to a reasonable frequency of emesis and diarrhea under the planned therapy, oral contraceptives are not considered highly effective”
- •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 76
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of s
排除标准
- •1. Non-epithelial tumor of the ovary, fallopian tube or 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
- •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 within 7 days prior to Day 1 Cycle 1
- •6. Administration of other chemotherapy drugs, anticancer therapy or antineoplastic hormonal therapy, or treatment with other investigational agents or devices within 28 days prior to randomization, or within a time interval less than at least 5 half-lives of the investigational agent
- •7. Palliative radiotherapy within 6 weeks prior to randomization or patients who have not completely recovered (Grade = 2) from the effects of previous 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 hour period or family history of long QT syndrome
- •11. Left ventricular ejection fraction defined by MUGA/ECHO below the institutional lower limit of normal
- •12. History or clinical suspicion of brain metastases or spinal cord compression
- •13. History or evidence upon neurological examination of central nervous system 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 treatment related complications
- •19. Pregnant or lactating women
- •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 within 2 weeks prior to Cycle 1 Day 1
- •24. History of autoimmune disease: 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 syndrome, Guillain-Barré syndrome, 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. HIV)
- •27. Signs or symptoms of infection within 4 weeks prior to Cycle 1 Day 1
- •28. Active tuberculosis
- •29. Administration of a live, attenuated vaccine
- •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 hamster ovary cells or to any component of t
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