EUCTR2015-005143-13-FR进行中（未招募）1 期
A randomised Phase II open-label study with a Phase Ib safety lead-in cohort of ONCOS-102, an immune-priming GM-CSF coding oncolytic adenovirus, and pemetrexed/cisplatin in patients with unresectable malignant pleural mesothelioma - MESOS
Targovax ASA0 个研究点目标入组 24 人开始时间: 2018年3月16日最近更新:
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
- 24
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
- •1. Male or female =18 years of age.
- •2. Histologically confirmed unresectable (advanced) malignant pleural mesothelioma in patients who are not candidates for curative surgery and for whom therapy with pemetrexed/cisplatin is considered appropriate.
- •o This includes patients who are naïve to chemotherapy,
- •o and those who have already received pemetrexed/cisplatin to which their tumour initially responded, but they have relapsed after at least 6 months.
- •3. Measurable disease according to RECIST 1.1 by CT scan.
- •4. Tumour accessible to i.t. injections of ONCOS-102 and to core needle biopsy or thoracoscopy for tissue sampling and immunohistochemistry analysis.
- •5. ECOG/WHO performance score of 0 or 1.
- •6. Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the Investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
- •7. Acceptable liver and renal functions defined as:
- •a. Total bilirubin = the upper limit of normal (ULN).
- •b. Aspartate aminotransferase (ASAT, SGOT), alanine aminotransferase (ALAT, SGPT) =3.0 x ULN.
- •c. Serum creatinine =1.5 x ULN
- •8. Acceptable haematological function defined as:
- •a. Haemoglobin =10 g/dL
- •b. Neutrophils =1.5 x 109/L
- •c. Platelet count =100 x 109/L
- •Patients can be transfused to meet the haemoglobin entry criteria.
- •9. Acceptable coagulation status: prothrombin time, international normalised ratio (INR) of blood clotting, and/or activated partial thromboplastin time within =1.5 x ULN.
- •10. All women of childbearing potential must have a negative urine or serum pregnancy test at screening and all patients must agree to use barrier contraception (i.e. condom) during study treatment and for 2 months after the last virus treatment and 6 months after the last dose of pemetrexed/cisplatin.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1.Receipt of oncolytic virus treatment, or vaccination with a vaccine containing live virus within 4 weeks before Day 1.
- •2.Use of significant immunosuppressive medication, including high dose corticosteroid (defined as the equivalent of >10 mg/day prednisone) within 4 weeks before Day 1.
- •3.Patients who participated in a study with an investigational drug or device within 4 weeks prior to Day 1.
- •4.Active bacterial, viral, or fungal infections, requiring systemic therapy.
- •5.Severe arrhythmia, heart failure, previous cardiac infarction, or acute inflammatory heart disease.
- •6.Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient, if included in this study.
- •7.Known infection with HIV, hepatitis B, or hepatitis C.
- •8.Known brain metastases.
- •9.History of organ transplant.
- •10.Females who are pregnant or breast feeding.
- •11.Unwillingness or inability to comply with the study protocol for any reason.
- •12.Patients with pre-existing hearing loss or neuropathy that may worsen due to potential neurotoxicity from cisplatin.
- •13.Patients with a history of hypersensitivity to cisplatin or pemetrexed or cyclophosphamide (or any of its metabolites).
- •14.Patients who are taking phenytoin for prophylactic use.
- •15.History of malignant tumour, unless the patient has been without evidence of disease for at least 3 years, or the tumour was a non-melanoma skin tumour, cervical carcinoma in situ, or prostatic carcinoma in situ.
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