EUCTR2015-005143-13-ES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
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
- Targovax Oy
- 入组人数
- 31
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.? Written informed consent.
- •2.? Male or female, ?18 years of age.
- •3.? 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.
- •4.? Measurable disease according to Response Evaluation in Solid Tumour (RECIST) 1.1.
- •5.? Tumour must be accessible to intratumoural (i.t.) injections and to tumour core needle biopsy or thoracoscopy for tissue sampling and immunohistochemistry analysis.
- •6.? Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance score 0 to 1.
- •7.? Acceptable liver, renal, and haematological functions.
- •8.? 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.
研究者
相似试验
进行中（未招募）
1 期
Patients with unresectable malignant pleural mesotheliomaEUCTR2015-005143-13-FRTargovax ASA24
进行中（未招募）
不适用
An open-label, randomised, phase II study in subjects with extensive disease, small cell lung cancer (ED-SCLC) after an initial response (complete response or partial response) to platinum-based therapy to determine the effect of EMD 273066 following low-dose cyclophosphamide on disease progression and survival versus best supportive care alone.extensive disease, small cell lungcancer (ED-SCLC)MedDRA version: 14.1Level: PTClassification code 10041071Term: Small cell lung cancer stage unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2006-004566-13-ITMERCK KGaA110
进行中（未招募）
不适用
An open-label, randomised, phase II study in subjects with extensive disease, small cell lung cancer (ED-SCLC) after an initial response (complete response or partial response) to platinum-based therapy to determine the effect of EMD 273066 following low-dose cyclophosphamide on disease progression and survival versus best supportive care alone.Small cell lung cancerEUCTR2006-004566-13-DEMerck KGaA110
进行中（未招募）
不适用
An open-label, randomised, phase II study in subjects with extensive disease, small cell lung cancer (ED-SCLC) after an initial response (complete response or partial response) to platinum-based therapy to determine the effect of EMD 273066 following low-dose cyclophosphamide on disease progression and survival versus best supportive care alone.Estudio en fase abierta, aleatorizado, de fase II en sujetos con enfermedad avanzada, en cáncer de pulmón microcítico (CPM), después de una respuesta inicial (respuesta completa o parcial) a una terapia basada en platino, para evaluar el efecto de EMD 273066 tras dosis bajas de ciclofosfamida sobre la progresión de la enfermedad y la supervivencia frente a la mejor terapia de soporte.EUCTR2006-004566-13-ESMerck KGaA110
进行中（未招募）
1 期
A phase II, randomised, open-label study to evaluate the safety and immunogenicity of the adjuvanted pandemic H1N1 influenza candidate vaccine following a 0-28 day or 0-4 month vaccination schedule in subjects aged 8 to 12 weeks. - FLU D-PAN H1N1-012Immunisation against A/California/7/2009 (H1N1)v-like influenza in male and female children aged 8 to 12 weeks.EUCTR2009-015174-35-NOGlaxoSmithKline Biologicals