EUCTR2018-002180-25-GB进行中（未招募）1 期
A multicentre randomised phase III trial comparing atezolizumab plus bevacizumab and standard chemotherapy versus bevacizumab and standard chemotherapy as first-line treatment for advanced malignant pleural mesothelioma - Bevacizumab and atezolizumab in malignant pleural mesothelioma
European Thoracic Oncology Platform (ETOP)0 个研究点目标入组 320 人开始时间: 2019年5月24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
- 320
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
- All
入选标准
- •- Histologically confirmed advanced malignant pleural mesothelioma (all histological subtypes are eligible)
- •- Not amenable for radical surgery based on local standards
- •- Evaluable disease or measurable disease as assessed according to the mRECIST v1.1
- •- Availability of tumour tissue for translational research. Either archival tumour or fresh biopsy sample taken >7 days prior to protocol treatment start.
- •- Age >18 years
- •- Performance Status 0-1
- •- Life expectancy >3 months
- •- Adequate haematological, renal (CrCl >45) and liver function
- •- Able to understand and give written informed consent and comply with trial procedures
- •Women of childbearing potential, including woman who had their last menstrual period in the last 2 years, must have a negative serum pregnancy test within 2 weeks before randomisation.
- •- Baseline QoL form has been completed
- •- Written Informed Consent for protocol treatment must be signed and dated by the patient and the investigator prior to any trial-related intervention.
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •- Prior treatment for malignant pleural mesothelioma. Prior radiotherapy for symptom control is allowed, but the irradiated lesion cannot be used as target lesion. If the patient has another target lesion, the patient is eligible.
- •- Treatment with systemic immune-stimulatory agents (including but not limited to interferons, interleukin-2) within 4 weeks or five half-lives of the drug, whichever is longer, prior to randomisation and during protocol treatment.
- •- Treatment with systemic immunosuppressive medications (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumour necrosis factor [anti-TNF] agents) within 2 weeks prior to randomisation and during protocol treatment. Patients who have received acute, low-dose (=10 mg oral prednisone or equivalent), systemic immunosuppressant medications may be enrolled in the trial.
- •- Previous allogenic tissue/solid organ transplant
- •- Live vaccines within 4 weeks prior to first dose of protocol treatment
- •- Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg). Anti-hypersensive therapy to achieve adequate control is allowable.
- •- Prior history of hypertensive crisis or hypertensive encephalphathy.
- •- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair of recent peripheral arterial thrombosis) within 6 months prior to randomisation
- •- History of haemoptysis (=one-half teaspoon of bright red blood per episode) within 1 month prior to randomisation
- •- Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
- •- Current or recent (within 10 days before randomisation) use of aspirin (>325 mg/day) or treatment with dipyridamole, ticlopidine, clopidogrel, and cilostazol
- •- Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes that has not been stable for >2 weeks prior to randomisation
- •- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of bevacizumab
- •- Major surgery or significant traumatic injury within 28 days prior to inclusion.
- •- Minor surgical procedure within 7 days, or placement of a vascular access device within 2 days of before randomisation.
- •- History of abdominal or tracheoesophageal fistula or gastrointestinal perforation withn 6 months prior to randomisation
- •- Clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
- •- Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
- •- Serious, non-healing wound, active ulcer, or untreated bone fracture
- •- Clear signs of tumour infiltration into the thoracic great vessels (on imaging)
- •- Clear signs of cavitation of pulmonary lesions (on imaging)
- •- Known history of severe allergic reactions to an platinum-containing compounds or any component of pemetrexed, bevacizumab or atezolizumab
- •- Grade =2 peripheral neuropathy as defined by NCI CTCAE v5.0
- •- HIV or active hepatitis B or hepatitis C
- •- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol
研究者
相似试验
进行中（未招募）
1 期
Trial comparing standard treatment (chemotherapy) with pembrolizumab Treatment in patients with advanced pretreated malignant pleural mesotheliomaAdvanced Malignant Pleural MesotheliomaMedDRA version: 20.0Level: LLTClassification code 10035605Term: Pleural mesothelioma malignant advancedSystem Organ Class: 100000004864EUCTR2016-002062-31-GBETOP (European Thoracic Oncology Platform)142
进行中（未招募）
1 期
Trial comparing standard treatment (chemotherapy) with pembrolizumab Treatment in patients with advanced pretreated malignant pleural mesotheliomaAdvanced Malignant Pleural MesotheliomaMedDRA version: 20.0Level: LLTClassification code 10035605Term: Pleural mesothelioma malignant advancedSystem Organ Class: 100000015981EUCTR2016-002062-31-ESETOP (European Thoracic Oncology Platform)144
进行中（未招募）
1 期
Comparison of atezolizumab and bevacizumab with standard chemotherapy versus bevacizumab with standard chemotherapy in treatment of the cancer called malignant pleural mesothelioma.EUCTR2018-002180-25-FREuropean Thoracic Oncology Platform (ETOP)320
进行中（未招募）
不适用
A multicenter randomized phase III trial to compare trastuzumab (Herceptin®) continuation or discontinuation in combination with 2nd-line chemotherapies after progression on a 1st-line chemotherapy combined with trastuzumab in patients with HER2 positive metastatic breast cancer (Treatment Beyond Progression, TBP) - PANDORAEUCTR2006-002860-25-LVRoche Hungary Ltd.274
进行中（未招募）
1 期
A multicenter randomized phase III trial to compare trastuzumab (Herceptin®) continuation or discontinuation in combination with 2nd-line chemotherapies after progression on a 1st-line chemotherapy combined with trastuzumab in patients with HER2 positive metastatic breast cancer (Treatment Beyond Progression, TBP) - PANDORAMetastacic breast cancerMedDRA version: 8.1Level: LLTClassification code 10027475Term: Metastatic breast cancerEUCTR2006-002860-25-SKRoche Hungary Ltd.274