EUCTR2017-000202-37-DK进行中（未招募）1 期
Atezolizumab in combination with Bevacizumab and Chemotherapy versus Bevacizumab and Chemotherapy in recurrent ovarian cancer – a randomized Phase III trial
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 550
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 with histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer
- •2.Relapsed disease
- •3.Patients with up to three prior therapies. In patients with 1 or 2 prior treatment lines, the treatment free interval after platinum has to be less than 6 months; in addition patients with three prior lines of chemotherapy who are not considered for platinum-containing chemotherapy lines are also eligible
- •4.Measurable disease, evaluable disease in combination with GCIG CA-125 criteria, or histologically proven relapse/progression
- •5. Mandatory de novo tumor biopsy (not older than 3 months) sent to central laboratory as formalin-fixed, paraffin-embedded (FFPE) sample for determination of PDL1 status prior to randomization for stratification.
- •6.Availability of a representative archival FFPE tumor sample (preferable from primary diagnosis)
- •7.Patient has not progressed on the chosen/planned chemotherapy (PLD or Paclitaxel) in any prior line
- •8.Patients previously treated with bevacizumab are eligible, with the exclusion of those patients that has suspended bevacizumab for more than 2 subsequent cycles or permanently discontinued bevacizumab during their previous treatment due to toxicity. A washout period of at least 20 days after last bevacizumab treatment must be adhered.
- •9.Females aged = 18 years at signing at time of signing informed consent form
- •10.Signed written informed consent and ability to comply with the study protocol, in the investigator’s judgement
- •11.Adequate hematological, renal and hepatic function within 28 days prior to first admin-istration of study treatment:
- •-Hemoglobin = 9.0 g/dl
- •-Absolute neutrophil count (ANC) = 1.5 x 10E9/L
- •-Platelet count = 100 x 10E9/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 Transam-inase (ALAT/SGPT) = 2.5 x ULN, unless liver metastases are present, in case of liver metastases values must be = 5 x ULN
- •-Serum creatinine = 1.5 x institutional ULN
- •-Patient not receiving anticoagulant medication who has 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). If the patient is on oral anticoagulants, dose has to be stable for at least two weeks at the time of ran-domization
- •-Urine dipstick for proteinuria < 2+. If urine dipstick is = 2+, 24-hours urine must demonstrate = 1 g of protein in 24 hours.
- •12.Patients must have adequately controlled blood pressure (BP), with a systolic BP of = 140 mmHg and diastolic BP of = 90 mmHg for eligibility. Patients must have a BP of = 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study.
- •13.Estimated life expectancy of at least 3 months
- •14.ECOG performance status 0 – 1
- •15.Negative urine or serum pregnancy test within 7 days of study treatment in women of childbearing potential (WOCBP), confirmed prior to treatment on day 1
- •16.For women of childbearing potential: agreement to remain abstinent (refrain from het-erosexual inter-course) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 5 months after administration of the last dose of atezolizumab/placebo and 6 months after the last
排除标准
- •1. Non-epithelial tumor origin of the ovary, the fallopian tube or the
- •2. Ovarian tumors of low malignant potential
- •3. Malignancies other than ovarian cancer within 5 years prior to
- •randomisation.
- •4. More than three prior systemic anticancer regimens; maintenance
- •therapies are not calculated as separate line
- •5. Prior systemic anticancer therapy within 28 days before
- •randomization
- •6. Prior radiotherapy to the pelvis or the abdomen.
- •7. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or
- •simultaneous radiotherapy during the trial treatment period.
- •8. Prior treatment with anti-CD137 or immune checkpoint blockade
- •therapies, anti-PD1, or anti-PD-L1 therapeutic antibodies or anti-CTLA 4
- •9. Prior randomization in AGO-OVAR 2.29.
- •10. Treatment with systemic immunostimulatory agents (including but not limited to inter-feron-alpha and interleukin-2 within 4 weeks or five half-lives of the drug (whichever is longer) prior to Cycle 1, Day 1
- •11. Treatment with systemic corticosteroids or other systemic
- •immunosuppressive medi-cations within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial. The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineral-ocorticoids.
- •12. Patients with a history of allergic reaction to IV contrast requiring
- •steroid pre-treatment should have screening and subsequent tumor
- •assessments performed using MRI.
- •13. 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 or within 5 months after the last dose of atezolizumab/placebo.
- •14. Major surgery within 4 weeks of starting study treatment or patient who has not completely recovered from the effects of any major surgery. Core biopsy or other minor surgical procedure within 7 days prior to day 1, cycle 1 is permitted.
- •15. Previous allogeneic bone marrow transplant or previous solid organ transplantation.
- •16. Current treatment with anti-viral therapy for HBV.
- •17. History of idiopathic pulmonary fibrosis (including pneumonitis),
- •organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) detected on screening chest CT scan is permitted
- •18. Previous Cerebro-Vascular Accident, Transient Ischemic Attack or
- •Sub-Arachnoids Hemorrhage within 6 months prior to randomization
- •19. History or evidence of hemorrhagic disorders within 6 months prior to randomization
- •20. Patients are excluded if having a history or evidence of thrombosis [...]
- •21. History or clinical suspicion of brain metastases or spinal cord compression.
- •22. History of autoimmune disease
- •23. Any prior history of hypertensive crisis (CTCAE grade 4) or hypertensive encephalopathy
- •31. Non-healing wound, active ulcer or bone fracture
- •31. History of bowel obstruction related to underlying disease, a history of abdominal fistula, GI perforation, intra-abdominal abscess, evidence of deep infiltration of the bowel by pelvic examination or on computed tomography, or clinical symptoms of bowel obstruction
- •32. Patients with evidence of abdominal free air
- •33. Evidence of any other disease, metabolic dysfunction, physical
- •examination finding, laboratory finding giving reasonable suspicion of
- •disease or condition that contraindicates the use of an invest
研究者
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