A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers

Tissue Procurement Inclusion Criteria:

Subjects will be eligible for tissue procurement for the Vigil manufacturing process, if they meet all of the following criteria:

• Histologically confirmed Stage IIIb, IIIc or IV high-grade papillary serous, clear cell, or endometrioid ovarian, fallopian tube or primary peritoneal carcinoma
• Age ≥ 18 years.
• Estimated survival ≥ 6 months.
• ECOG Performance Status ≤ 1
• Metastatic disease
• Planned standard of care surgical procedure (e.g., tumor biopsy or palliative resection or thoracentesis) and expected availability of a cumulative soft-tissue mass of ~10-30 grams tissue ("grape" to "golf-ball" size) or ascites fluid estimated volume ≥ 500mL (from a primary or secondary paracentesis, yielding in a high volume of tumor cells) for immunotherapy manufacture.
• Tumor intended for immunotherapy manufacture is not embedded in bone and does not contain luminal tissue (e.g. bowel, ureter, bile duct).
• Ability to understand and the willingness to sign a written informed protocol specific consent for tissue harvest or a parental/guardian informed consent and pediatric assent when appropriate.

Tissue Procurement Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible for tissue procurement for the Vigil manufacturing:

• Medical condition requiring any form of chronic systemic immunosuppressive therapy (steroid or other) except physiologic replacement doses of hydrocortisone or equivalent (no more than 30 mg hydrocortisone or 10 mg prednisone equivalent daily) for 100 × 10e9/L (100,000 per mm^3)
• Hemoglobin ≥9.0 g/dL (5.59 mmol/L)
• Creatinine clearance (CrCL) >50 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance:

Females:

CrCL (mL/min) = Weight (kg) × (140 - Age) × 0.85/72 × serum creatinine (mg/dL)

• Serum bilirubin ≤1.5 × upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of evidence of hemolysis or hepatic pathology) who will be allowed in consultation with their physician.
• AST and ALT ≤2.5 × ULN in patients with no liver metastasis
• AST or ALT ≤5 × ULN in patients with liver metastasis
• TSH within institutional limits. If TSH is greater or less than institutional limits patients may participate if their T4 is within normal limits (WNL); patients may be on a stable dose of replacement thyroid medication; dose adjustments are allowed if needed
• Subject has recovered to CTCAE Grade 1 or better from all adverse events associated with prior therapy or surgery (or ≤ 2 due to carcinoid syndrome).
• Pre-existing motor or sensory neurologic pathology or symptoms must be recovered to CTCAE Grade 2 or better
• Patients with irreversible toxicity that is not reasonably expected to be exacerbated by the IPs (Vigil and/or atezolizumab) may be included (e.g., hearing loss) after consultation with the Principal Investigator
• Subjects who are not rendered surgically sterile as a result of surgery for ovarian cancer, must have, negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a negative serum test will be required for study entry.
• Ability to understand and the willingness to sign a written informed protocol specific consent.
• Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. Patients must have fully recovered from chemotherapy associated toxicities prior to starting treatment on this protocol.
• Palliative radiotherapy is permitted provided:
• More than 3 weeks have elapsed between the end of radiotherapy and the first dose of study therapy, AND
• The irradiated lesion(s) (unless measurable progression after irradiation) cannot be used as target lesions.

Study Enrollm