JPRN-jRCT2051220186
Recruiting
未知
Expanded Access Program with Nivolumab (ONO-4538) for malignant non-pleural mesothelioma (VIOLA)VIOLA: niVolumab in malIgnant non-pleural mesOtheLiomA - VIOLA-EX Study
Kijima Takashi0 sites15 target enrollmentMarch 8, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Malignant Mesothelioma
- Sponsor
- Kijima Takashi
- Enrollment
- 15
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.AgeOver 20 years on the date of informed consent
- •2\.Pathologically confirmed non\-pleural malignant mesothelioma
- •3\.a.Patients with peritoneal mesothelioma having at least one measurable lesion designated according to RECIST guidelines, Version 1\.1
- •b.Patients with mesothelioma originated from pericardium or tunica vaginalis without having no measurable lesions.
- •4\.Advanced or metastatic MNPM (malignant non\-pleural mesothelioma) that is with or without prior treatment
- •5\.Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •6\.Patients expected to survive over 90 days
- •7\.Patients with percutaneous oxygen saturation over 94%, as measured by pulse oximeter at rest, without supplemental O2 within 7 days before enrollment. However, if the baseline measurement is not included within 7 days before the initial dose of the investigational product, it should be reconfirmed that the baseline measurement is met.
- •8\.Patients whose latest laboratory values obtained within 7 days of enrollment meet the following criteria. However, if the laboratory test at the time of registration is not included within 7 days before the first administration of the investigational product, it should be reconfirmed that the laboratory test before the first administration of the investigational product meets the following criteria. In all cases, laboratory test values are those for which granulocyte colony\-stimulating factor (G\-CSF formulation) or blood transfusion was not received within 14 days before the test date. White blood cell count \> 2,000/m3 and neutrophil count \> 15000/m3 Platelet count \>\= 100,000/m3 Hb \>\= 8\.0 g/dL AST (GOT) and ALT (GPT) are not more than 3\.0 times the upper limit of the facility reference value. Total bilirubin not more than 2\.0 times the upper limit of institutional standard value Serum creatinine not more than 1\.5 times the upper limit of the reference value at the institution Or creatinine clearance (Cockcroft estimates) \> 45 m L/min.
- •9\.Patients who have been fully informed of the details of the study by the investigator or sub investigator using a written informed consent form and who voluntarily agree to participate in the study
Exclusion Criteria
- •1\.Complication or history of severe hypersensitivity reactions to any drugs
- •2\.History of concomitant, chronic, or recurrent autoimmune diseases
- •3\.Multiple cancers
- •4\.Brain or meningeal metastases
- •5\.Complication or history of interstitial lung disease or pulmonary fibrosis
- •6\.Coexisting diverticulitis or symptomatic gastrointestinal ulcer disease
- •7\.Accumulation of pericardial effusion or ascites requiring drainage every 2 weeks or more
- •8\.Pain associated with uncontrollable tumors
- •9\.Transient ischemic attack, cerebrovascular attack, thrombosis, or thromboembolism within 180 days before enrollment.
- •10\.Uncontrolled or significant cardiovascular diseases
Outcomes
Primary Outcomes
Not specified
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