EUCTR2019-004916-76-IT进行中（未招募）1 期
A phase II study of nivolumab combined with metformin in pre-treated metastatic renal cell carcinoma (mRCC) patients. - NivoMet
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 21 人开始时间: 2020年10月21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
- 21
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.Willing and able to provide written informed consent
- •2.Male aged 18 years and above
- •3.Histological confirmation of RCC with a clear cell component
- •4.Advanced or metastatic RCC
- •5.Measurable disease as defined by RECIST1.1criteria
- •6.Must have received at least one prior systemic treatment regimen in the advanced or metastatic setting, and must have evidence of progression on or after the last treatment regimen received
- •7.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- •8.Adequate bone marrow and chemistry values defined as:
- •a.Hemoglobin = 9.0 g/dL independent of transfusion
- •b.Platelet count =100.000/µL
- •c.Serum creatinine < 1.5 x ULN or a calculated creatinine clearance = 40 mL/min
- •d.Liver function:
- •i.Serum bilirubin < 1.5 x ULN (except for patients with documented Gilbert’s disease)
- •ii.AST or ALT < 2.5 x ULN
- •9.Life expectancy of at least 6 months
- •10.Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration.
- •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 9
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1.Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection
- •2.Any active known or suspected autoimmune disease
- •3.Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study drug. Inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease
- •4.Uncontrolled adrenal insufficiency
- •5.Evidence of active pneumonitis during screening, except for pulmonary fibrosis induced by prior thoracic irradiation
- •6.Dialitic patients
- •7.Diabetes mellitus
- •8.Any history of biguanide-based therapy within 1 year prior to enrollment
- •9.Current severe, uncontrolled systemic disease
- •10.Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline
- •11.Other malignancy with a previous diagnosis within 5 years (with the exclusions of NMIBC, CIN).
- •12.Prior treatment with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
研究者
相似试验
进行中（未招募）
1 期
ivolumab in combination with temozolomide and radiotherapy in children and adolescents with newly diagnosed high-grade gliomaewly diagnosed High-Grade Gliomas (HGG)MedDRA version: 20.0 Level: PT Classification code 10065443 Term: Malignant glioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10018338 Term: Glioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-002688-24-FRGustave Roussy40
进行中（未招募）
1 期
Treatment of advanced lung cancerPatients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) and patients with Small cell lung cancer (SCLC) after failure of platinum-based first-line therapy.MedDRA version: 21.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10041070Term: Small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10059514Term: Small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-003334-25-DEniversity of Cologne90
进行中（未招募）
1 期
A multicenter phase 2 study of nivolumab combined with ipilimumab in patients with pediatric solid tumors presenting in adulthoodEUCTR2016-003946-99-ESGrupo Español de Tumores Huérfanos e Infrecuentes (GETHI)98
进行中（未招募）
1 期
A randomized, run-in, phase II study of nivolumab combined with ipilimumab and guadecitabine or nivolumab combined with ipilimumab in melanoma and NSCLC patients resistant to anti-PD-1/PD-L1MM and NSCLC patients resistant to anti-PD-1/PD-L1 therapyMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-002986-36-ITFONDAZIONE NIBIT NETWORK ITALIANO PER LA BIOTERAPIA DEI TUMORI184
进行中（未招募）
1 期
A phase II study of nivolumab monotherapy in patients with relapsed/refractory Hodgkin lymphoma fit for autologous stem cell transplant who fail to reach complete metabolic remission after first or second line salvage therapyEUCTR2017-002544-32-GBniversity College London120