EUCTR2014-003935-20-NL进行中（未招募）不适用
A single arm phase II study of Nivolumab in patients with progressive malignant pleural mesothelioma: interim biopsy analysis to determine efficacy. Acronym: NivoMes Study
Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis0 个研究点开始时间: 2015年1月15日最近更新:
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研究概览
简要总结
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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
- •Patients with proven malignant pleural mesothelioma, who have progressive disease after chemotherapy in first or second line.
- •Patients with histological or cytological diagnosed malignant pleural mesothelioma and age >18 years.
- •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 of painful sites, the interval is > 12 weeks, not more than 1/3 of the bone marrow capacity or all tumor is within the irradiation field.
- •WHO performance status 0 or 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 within the upper normal limits; ASAT and ALAT = 2.5 times the upper limits of normal (ULN), AP (alkaline phosphatases) < 5x ULN (unless bone metastases are present in the absence of any liver disease).
- •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 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
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 4.0.
- •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
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