NCT03267589已完成2 期
NSGO-OV-UMB1; ENGOT-OV30 / NSGO: A Phase II Umbrella Trial in Patients With Relapsed Ovarian Cancer
Nordic Society of Gynaecological Oncology - Clinical Trials Unit5 个研究点 分布在 3 个国家目标入组 25 人开始时间: 2018年5月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 5
- 主要终点
- Disease control rate (DCR)
研究概览
简要总结
The overall objectiv is to obtain preliminary evidence of efficacy of novel agents for the management of relapsed ovarian cancer, and in part 2 efficacy of novel agents compared to the standard of care (SoC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Platinum-sensitive disease: defined as disease progression ≥ 6 months following the last administered dose of platinum-based therapy. Patients must have received atleast one line of chemotherapy for platinum-sensitive disease. OR
- •Platinum-resistant disease: defined as disease progression < 6 months following the last administered dose of platinum-based therapy.
- •Platinum-refractory disease: defined as lack of response or disease progression while receiving the most recent therapy.
- •Other key inclusion criteria:
- •Histological confirmed ovarian, fallopian tube or peritoneal cancers.
- •Histological types: high-grade serious, high-grade endometriod, undifferentiated, carcinosarcoma or mixed histology.
- •Subjects must have at least 1 measurable lesion as defined by RECIST guidelines. This should not be the same lesion used for biopsy.
- •Patients entering cohort A: Archival tumour tissue must be screened for CD73 and only CD73 positive patients (defined as >10% of tumor cells positive) will enter this trial.
- •Patient agrees to undergo all analysis (blood, serum, tissue); radiological examinations according to protocol.
- •Mandatory tumour biopsy before treatment (before day 0) and at day 56 of treatment.
- •Patients must give informed consent.
- •Patients must be at least 18 years of age.
- •ECOG performance status 0-1
- •Serum albumin >30g/l.
- •Adequate organ function
- •Life expectancy of at least 12 weeks.
- •Patients must be fit to receive Investigational medical products (IMPs)
排除标准
- •Subjects using immunosuppressive medications within 14 days.
- •Immunodeficiency or organ transplant
- •Live vaccines within 28 days prior to the first dose.
- •Major surgery within 28 days prior to the first dose.
- •Ovarian sarcomas, small cell carcinoma with neuroendocrine differentiation, non-epithelial can-cers.
- •Cancer therapies (chemotherapy, radiotherapy, surgery, immunotherapy, biologic or hormonal therapy) within 28 days prior to the first dose.
- •Concurrent treatment with an investigational agent or participation in another clinical trial.
- •Previous malignant disease: patients are not eligible for the study if actively being treated of inva-sive cancer other than ovarian cancer. Patients with previous malignant disease other than ovarian cancer who are relapse-free and treatment-free for more than three years may enter this study. Pa-tients with previous history of in-situ carcinoma, stage 1A cervical cancer or non-invasive basal cell and squamous cell skin carcinoma can enter this trial.
- •Active infection including tuberculosis
- •History of a cerebral vascular accident, transient ischemic attack or subarachnoid hemorrhage within the past 6 months.
- •History of clinically significant hemorrhage in the past 3 months.
- •Untreated CNS disease, leptomeningeal disease or cord compression. Subjects with treated dis-ease should have at least 4 weeks of neurologic and radiographic stability and be off steroids for 14 days.
- •Significant cardiovascular disease's.
- •Persistance of clinically relevant therapy related toxicity from previous anticancer therapy (any grade 3-4 toxicity or grade ≥2 neuropathy).
- •Known hypersensitivity to the trial drugs, or to their excipients.
- •Has had prior exposure to IMPs, or any other immunotherapy.
- •Active or prior documented autoimmune or inflammatory disorders
- •For cohorts B and C: Medical condition requiring current systemic anticoagulation, or a history of congenital hypercoagulable condition. Subjects taking aspirin at doses < 325 mg per day are eli-gible provided that prothrombin time is within the institutional range of normal. Use of local anti-coagulation for port maintenance is permitted
研究组 & 干预措施
Cohort B
Experimental
Intervention: MEDI0562 (OX40) + durvalumab
干预措施: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562 (Drug)
Cohort A
Experimental
Intervention: MEDI9447 (CD73) + durvalumab
干预措施: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562 (Drug)
Cohort C
Experimental
Intervention: MEDI0562 (OX40) + tremelimumab combination
干预措施: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562 (Drug)
结局指标
主要结局
Disease control rate (DCR)
时间窗: 16 weeks
Disease control rate (DCR) (CR+PR+SD)
次要结局
- Objective response rate(10 months)
- PFS by Immune-RECIST(10 months)
- Duration of (Overall) Response (DoR)(10 months)
- Progression-Free Survival (PFS) by RECIST v1.1(10 months)
- Overall survival (OS)(36 months)
研究者
研究点 (5)
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