EUCTR2015-005471-24-FR进行中（未招募）1 期
A randomized, double-blinded, phase III study of atezolizumab versus placebo in patients with late relapse of epithelial ovarian, fallopian tube, or peritoneal cancer treated by platinum-based chemotherapy and bevacizumab - ATALANTE : ATezolizumab and Avastin in LAte recurreNT diseasE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 405
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
- •I-1. Female Patients must be =18 years of age.
- •I-2. Signed informed consent and ability to comply with treatment and follow-up.
- •I-3. Patients with histologically confirmed non-mucinous epithelial ovarian cancer, primary peritoneal adenocarcinoma and / or fallopian-tube adenocarcinoma
- •I-4. Patients with known PD-L1 status on fresh mandatory biopsy sent to central laboratory as a formalin-fixed, paraffin-embedded (FFPE) sample.
- •- Cell pellet from pleural effusion, or ascites or lavage are not acceptable.
- •- For core needle biopsy specimens, at least two cores should be obtained. Biopsies must be obtained in a manner that minimizes risks. If the location of the tumor renders tumor biopsy medically unsafe or not feasible, patient eligibility should be discussed with the sponsor.
- •I-5. Patients whose disease has relapsed more than 6 months from the last dose of platinum before randomization:
- •a) criterion for relapse can be according to RECIST v1.1, CA125 (GCIG) or clinical symptoms
- •b) the interval between last dose of platinum and entry in the study should be free of new anti-cancer treatment, with the exception of a maintenance therapy which is allowed up to 21 days before study entry.
- •I-6. Patients with one or 2 prior lines of chemotherapy. The last line of chemotherapy should have included platinum.
- •I-7. Availability at the study site of a representative FFPE tumor sample or at least 15 unstained slides from debulking surgery during front-line therapy
- •I-8. Patients must have normal organ and bone marrow function :
- •a) Haemoglobin = 10.0 g/dL.
- •b) Absolute neutrophil count (ANC) = 1.5 x 109/L.
- •c) Platelet count = 100 x 109/L.
- •d) Total bilirubin = 1.5 x institutional upper limit of normal (ULN).
- •e) Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) = 2.5 x ULN, unless liver metastases are present in which case they must be = 5 x ULN.
- •f) Serum creatinine = 1.5 x institutional ULN,
- •g) Patients not receiving anticoagulant medication who have an International Normalized Ratio (INR) =1.5 and an Activated ProThrombin Time (aPTT) =1.5 x ULN. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or APTT is within therapeutic limits (according to site medical standard) and if the patient is on a stable dose of anticoagulants for at least two weeks at the time of randomization.
- •h) Urine dipstick for proteinuria < 2+. If urine dipstick is =2+, 24-hours urine must demonstrate =1 g of protein in 24 hours.
- •i) Normal blood pressure or adequately treated and controlled hypertension (systolic BP = 140 mmHg and/or diastolic BP = 90 mmHg).
- •I-9. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •For France only: In France, a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of, a social security category.
- •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 243
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 162
排除标准
- •E-1. Non-epithelial tumor origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors).
- •E-2. Ovarian tumors of low malignant potential (e.g. borderline tumors)
- •E-3. Patients with synchronous primary endometrial cancer unless both of the following criteria are met:
- •a) stage < II,
- •b) Less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid adenocarcinoma OR = 60 years old at the time of diagnosis of endometrial cancer with stage IA grade 1or 2 endometrioid adenocarcinoma.
- •c) Patients with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible.
- •E-4. Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS).
- •E-5. Patients receiving radiotherapy within 6 weeks prior to study treatment.
- •E-6.Major surgery within 4 weeks of starting study treatment or patients who have not completely recovered from the effects of any major surgery.
- •E-7. Previous allogeneic bone marrow transplant or previous solid organ transplantation.
- •E-8. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted).
- •E-9. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD1, or anti-PDL1 therapeutic antibodies or anti-CTLA 4.
- •E-10. Treatment with systemic immunostimulatory agents
- •E-11. Treatment with systemic corticosteroids or other systemic immunosuppressive médications.
- •a) The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.
- •b) Prophylactic anti-emetic corticosteroids will be avoided if possible in patients treated with pegylated liposomal doxorubicin-carboplatin or gemcitabine-carboplatin regimen. The use of corticosteroids is allowed as premedication for paclitaxel-based regimen and/or premedication in case of carboplatin hypersensitivity.
- •E-12. History of autoimmune disease
- •E-13. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis. Radiation pneumonitis in the radiation field (fibrosis) detected on screening chest CT scan is permitted
- •E-14. Immunocompromised patients,
- •E-15. Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
- •E-16. Administration of a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study.
- •E-17. Current or recent (within 10 days prior to randomization) chronic use of aspirin > 325 mg/day.
- •E-18. Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy.
- •E-19. Inadequately controlled HTN
- •E-20. Clinically significant (e.g. active) cardiovascular disease, including:
- •a) Myocardial infarction or unstable angina within = 6 months of randomization,
- •b) New York Heart Association (NYHA) = grade 2 congestive heart failure (CHF),
- •c) Poorly controlled cardiac arrhythmia despite medication (p
研究者
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