NCT02497508已完成2 期
A Single Arm Phase II Study of Nivolumab in Patients With Recurrent Malignant Pleural Mesothelioma: Interim Biopsy Analysis to Determine Efficacy. Acronym: NivoMes Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- DCR
研究概览
简要总结
This is a prospective, single arm, phase II trial in previously treated patients with MPM who are considered candidates for immunotherapy and repeat thoracoscopies/transthoracic biopsies. Nivolumab will be administered 3 mg/kg q2 weeks by intravenous injection.
The administration of nivolumab as monotherapy will improve DCR form 20% to 40% at 12 weeks when compared to DCR of patients treated with best supportive care based on historical controls.
详细描述
Patients will undergo pre- and post-treatment thoracoscopies/biopsies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histological or cytological diagnosed malignant pleural mesothelioma and age >18 years.
- •Progressive disease after at least one course of chemotherapy.
- •Previous chemotherapy or experimental therapy ≥ 4 weeks ago.
- •Medically suitable for limited surgical intervention (pleural biopsies up to limited pleurectomy).
- •Not considered candidates for trimodality treatment (as part of a study).
- •Measurable or evaluable disease (see tumor response assessment).
- •Ability to understand the study and give signed informed consent prior to beginning of protocol specific procedures including the approval of a second thoracoscopy or transthoracic pleural biopsy after the third course.
- •Radiotherapy is allowed when this is given for palliation, the interval is > 12 weeks and not all tumor is within the irradiation field.
- •WHO performance status 0 or 1 (see appendix 1).
- •Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:
- •Hematology: Neutrophil count >= 1.5 x 109/l, Platelets >= 150 x 109/l, Hemoglobin >= 6,0 mmol/l.
- •Chemistry: Total serum bilirubin ≤ 1.5 times within the upper limits of normal (ULN); ASAT and ALAT <= 2.5x ULN, AP (alkaline phosphatases) < 5x ULN (unless bone metastases are present in the absence of any liver disease).
- •Age and Reproductive Status
- •Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception to avoid pregnancy during treatment and for 23 weeks after the last dose of investigational drug.
- •Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the first dose of nivolumab.
- •Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year during treatment and for a period of 31 weeks after the last dose of investigational drug.
- •Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception.
排除标准
- •Active uncontrolled infection, severe cardiac dysfunction or uncorrectable bleeding tendency.
- •Inability to perform biopsies of the pleural lesions.
- •Symptomatic peripheral neuropathy >= grade 2 according to NCI CTC, version 4.
- •Presence of symptomatic CNS metastases.
- •Unstable peptic ulcer, unstable diabetes mellitus or other serious disabling condition.
- •Impaired renal function: creatinine clearance less than 50ml/min.
- •Concomitant administration to any other experimental drugs under investigation.
- •Patients are excluded if they have an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
- •Patients are excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immuno-suppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- •Patients are excluded if they have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
研究组 & 干预措施
Nivolumab
Experimental
Nivolumab will be administered 2 weekly by intravenous infusion in a dose of 3 mg/kg
干预措施: nivolumab (Drug)
结局指标
主要结局
DCR
时间窗: at 12 weeks
The number of patients that have CR or PR plus the number of patients that have SD, as a percentage of the total number of patients in the study.
次要结局
- OS(every 8 weeks until death)
- TTP(Until progression, every 6 weeks up to 24 weeks.)
- DCR(At 6 months)
- ORR(Every 6 weeks up to 24 weeks.)
- Safety and tolerability (The incidence of (serious) adverse events)(Participants will be followed fot the duration of the trial, an expected average of 6 weeks)
- PFS(Until progression, every 6 weeks up to 24 weeks.)
研究者
相似试验
进行中（未招募）
2 期
ANIMATE: Phase II Study of Nivolumab Monotherapy for Relapsed/Refractory Hodgkin LymphomaHodgkin LymphomaNCT03337919University College, London78
已完成
2 期
Ipilimumab and Nivolumab in the Treatment of Malignant Pleural MesotheliomaMalignant Pleural MesotheliomaNCT03048474The Netherlands Cancer Institute36
进行中（未招募）
2 期
Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal MelanomaMucosal MelanomaNCT03241186Robert R. McWilliams, MD36
已完成
2 期
Study Of Nivolumab Alone, Or In Combination With Vinblastin In Patients With Classical Hodgkin LymphomaCoexisting Medical ConditionsHodgkin LymphomaNCT03580408The Lymphoma Academic Research Organisation64
终止
2 期
Nivolumab in Treating Patients With Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, or Post-Polycythemia Vera MyelofibrosisHepatomegalyMyelofibrosis Transformation in Essential ThrombocythemiaPolycythemia Vera, Post-Polycythemic Myelofibrosis PhaseSplenomegalyPrimary MyelofibrosisNCT02421354M.D. Anderson Cancer Center8