EUCTR2014-003935-20-NL
Active, not recruiting
Not Applicable
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 sitesStarted: January 15, 2015Last updated:
ConditionsA single arm phase II study of Nivolumab in patients with progressive malignant pleural mesothelioma: interim biopsy analysis to determine efficacy. Acronym: NivoMes StudyMedDRA version: 17.1Level: LLTClassification code 10027408Term: Mesothelioma malignant advancedSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Investigators
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