A Study of Ad-RTS-hIL-12 With Veledimex in Combination With Nivolumab in Subjects With Glioblastoma; a Substudy to ATI001-102

Inclusion Criteria

• •Male or female subject ≥18 and ≤75 years of age
• •Provision of written informed consent for tumor resection, stereotactic surgery, tumor biopsy, samples collection, and treatment with investigational products prior to undergoing any study specific procedures
• •Histologically confirmed supratentorial glioblastoma
• •Evidence of tumor recurrence/progression by magnetic resonance imaging (MRI) according to response assessment in neuro-oncology (RANO) criteria after standard initial therapy
• •Previous standard-of-care antitumor treatment including surgery and/or biopsy and chemoradiation. At the time of registration, subjects must have recovered from the toxic effects of previous treatments as determined by the treating physician. The washout periods from prior therapies are intended as follows: (windows other than what is listed below should be allowed only after consultation with the Medical Monitor)
• •1. Nitrosureas: 6 weeks
• •2. Other cytotoxic agents: 4 weeks
• •3. Antiangiogenic agents, including bevacizumab: 4weeks
• •4. Targeted agents, including small molecule tyrosine kinase inhibitors: 2 weeks
• •5. Vaccine-based therapy: 3 months
• •Able to undergo standard MRI scans with contrast agent before enrollment and after treatment
• •Karnofsky Performance Status ≥70%
• •Adequate bone marrow reserves and liver and kidney function, as assessed by the following laboratory requirements:
• •1. Hemoglobin ≥9 g/L
• •2. Lymphocytes \>500/mm3
• •3. Absolute neutrophil count ≥1500/mm3
• •4. Platelets ≥100,000/mm3
• •5. Serum creatinine ≤1.5 x upper limit of normal (ULN)
• •6. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x ULN. For subjects with documented liver metastases, ALT and AST ≤5 x ULN
• •7. Total bilirubin \< 1.5 x ULN
• •8. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) within normal institutional limits
• •Male and female subjects must agree to use a highly reliable method of birth control (expected failure rate \<5% per year) from the Screening Visit through 28 days after the last dose of study drug. Women of childbearing potential (perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential) must have a negative pregnancy test at screening.
• •Normal cardiac and pulmonary function as evidenced by a normal electrocardiogram (ECG) and peripheral oxygen saturation (SpO2) ≥90% by pulse oximetry