Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma

Inclusion Criteria

Patients who meet all of the following criteria will be eligible to participate in the study:

• Aged 18 years or older at the time of consent;
• Able to give informed consent;
• Has a confirmed histological diagnosis of MPM with histological type epithelioid or biphasic (if biphasic, histology must be predominantly [50%] epithelioid). Histological diagnosis of MPM will be confirmed centrally using specimens or slides from tumor specimens obtained at the time of initial presentation or a subsequent procedure. Central confirmation of diagnosis with immunohistochemistry will be performed, and independent central confirmation will be required for study entry;
• Measurable disease, per modified Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 (see Section 7) for pleural mesothelioma;
• Has received a minimum of 1 treatment regimen and a maximum of 2 treatment regimens, which may have been chemotherapeutic and/or immunotherapeutic treatment regimens for MPM which included at least 1 anti-folate and platinum combination regimen;
• Adjuvant or neoadjuvant therapy represent 1 line of therapy each;
• Patients who have undergone primary surgical resection and/or radiation therapy to the pulmonary site are eligible to participate. For clarity, surgical resection and/or radiation therapy to the pulmonary site are not exclusionary and are not considered a line of therapy;
• Treatment that is split between pre-surgical resection and post-surgical resection and is the same regimen will be counted as 1 regimen. Patients meeting this condition should be discussed with the Medical Monitor prior to including the patient in the study;
• Has a pleural space accessible for IPC or similar device insertion. Patients with a previously inserted IPC or similar device may be enrolled, and the pre-existing IPC or similar device can be used for vector administration as long as it is functional and has no evidence of local infection;
• Life expectancy 12 weeks in the judgement of the Investigator;
• Eastern Cooperative Oncology Group (ECOG) status of 1 or 0;
• Female and male patients:
• Female patients of childbearing potential must have a negative pregnancy test upon entry into this study and agree to use a highly effective method of contraception from Screening until 1 month after the last dose of gemcitabine;
• Highly effective methods of contraception that result in a low failure rate (i.e., 160/100 mmHg) requiring 3 or more anti-hypertensive drugs;
• Heart rate corrected QT interval using Fridericia's formula >470 ms on resting 12-lead electrocardiogram (ECG);
• Patients receiving lithium;
• Any significant disease which, in the opinion of the Investigator, would place the patient at increased risk of harm if he/she participated in the study;
• History of a prior malignancy for which treatment was completed 1.5 ULN;
• History of clinically significant inflammatory bowel disease requiring systemic (parenteral) immunosuppressive therapy within 5 years prior to Screening; or
• History of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.