Expanded Access Program with Nivolumab (ONO-4538) for malignant non-pleural mesothelioma (VIOLA)

JRCT ID: jRCT2051220186

Registered date:08/03/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Malignant Mesothelioma
• Date of first enrollment: 08/03/2023
• Target sample size: 15
• Study type: Interventional
• Intervention(s): ONO-4538 240mg, every 2 weeks

Outcome(s)

Primary Outcome

safety
1.adverse event
2.Laboratory tests (Hematologic, biochemical, qualitative urine, immunologic, and hormonal tests)
3.Vital signs (Systolic/diastolic BP, pulse rate, percutaneous oxygen saturation (S p O2), temperature), weight
4.12-lead electrocardiogram
5.chest X-ray
6.ECOG Performance Status

Secondary Outcome

The secondary endpoints include efficacy, which will be evaluated using the following methods, adhering to the RECIST guidelines, version 1.1:
(1) Overall response rate (ORR) as assessed by the investigators;
(2) Disease control rate (DCR; central decision);
(3) OS time;
(4) Progression-free survival (PFS; median);
(5) Duration of response (DOR; central decision);
(6) Time to response (TTR; central decision);
(7) Best overall response (BOR; central decision).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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
11.Receiving anticoagulant therapy, but including low-dose aspirin
12.Uncontrolled diabetes
13.Systemic infections requiring treatment
14.Obviously positive for human immunodeficiency virus (HIV)
15.HTLV-1 antibody-positive, HBs antigen-positive, or HCV antibody-positive. Either HBs antigen positive or HBc antibody-positive and HBV-DNA detection if HBs antigen is negative
16.Surgery with general, local, or surface anesthesia within 14 days before enrollment
17.Pleural, peritoneal, or pericardial adhesions within 28 days before enrollment
18.History of treatment for T-cell regulation within 28 days before enrollment
19.Palliative radiation therapy within 14 days before enrollment
20.Radiopharmaceuticals therapy within 56 days before enrollment
21.Administration of unapproved drugs within 28 days or an unapproved antibody within 90 days
22.Received systemic corticosteroids or immunosuppressants above 10 mg/day of prednisolone equivalent within 28 days before enrollment
23.Received live or attenuated vaccines within 28 days before registration
24.Pregnant women
25.Patients judged to lack the ability to consent due to complications such as dementia
26.Other patients judged by the investigator unsuitable for this study

Related Information

• Primary Sponsor: Kijima Takashi
• Source(s) of Monetary Support: ONO PHARMACEUTICAL CO., LTD.