NL-OMON41970
Completed
Phase 2
A single arm phase II study of Nivolumab in patients with progressive malignant pleural mesothelioma: interim biopsy analysis to determine efficacy. Acronym: NivoMes Study - Nivolumab in patients with progressive MPM: NivoMes
Antoni van Leeuwenhoek Ziekenhuis0 sites33 target enrollmentStarted: TBDLast updated:
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 33
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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.
- •\* 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 of painful sites, the interval is \> 12 weeks and not all tumor is within the irradiation field.
- •\* WHO performance status 0 or 1 (see appendix 1\).
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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ivolumab in patients with progressive malignant pleural mesothelioma: NivoMesA 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]EUCTR2014-003935-20-NLStichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
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