Clinical Trial of Chemotherapy, Oregovomab and Nivolumab in Patients With Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin

Cancer-specific Exclusions

Non-epithelial ovarian tumors or ovarian tumors with low malignant potential (i.e., borderline tumors). Note: ovarian carcinosarcomas are eligible.

Active symptomatic central nervous system (CNS) metastases. Patients with previous CNS metastases are eligible provided that they underwent CNS irradiation, are asymptomatic, do not require treatment with radiation therapy or anticonvulsants, and have stable disease at the screening tumor assessment. In addition, these patients must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisolone (or equivalent).

Spinal cord compression not definitively treated with surgery and/or radiation. Patients with previously diagnosed and treated spinal cord compression are eligible provided that they have stable disease at the screening tumor assessment. In addition, these patients must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisolone (or equivalent).

Leptomeningeal carcinomatosis

Uncontrolled pleural effusion(s), pericardial effusion or ascites requiring recurrent drainage procedures (Patients with functioning pleural and/or peritoneal drainage catheters/devices in situ at time of study entry may be eligible.)

Previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at least 2 years before study entry AND no additional therapy is required, or anticipated to be required, during the study period

General Medical Exclusions

Pregnant or lactating women

Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome

Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months before study entry, unstable arrhythmias/heart block, or unstable angina

Severe infections within 4 weeks before study entry including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia

History of abdominal fistula, history of gastrointestinal perforation, and signs or symptoms of bowel obstruction

Symptoms or radiological evidence of active bowel obstruction

Non-healing wound or ulcer, or bone fracture within 3 months before study entry.

Concurrent anticancer treatment within 28 days before study entry, e.g. cytotoxic chemotherapy, radiotherapy (except for palliative bone-directed radiotherapy), immunotherapy, cytokine therapy (except for erythropoietin); major surgery within 28 days before study entry (excluding diagnostic biopsy); use of hormonal agents within 7 days before study entry; or use of any investigational drug within 28 days before study entry. Patients receiving bisphosphonate or denosumab are eligible provided treatment was initiated at least 14 days before study entry.

Seizure disorder requiring anti-epileptic medication

Renal failure requiring hemo- or peritoneal dialysis

Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or administration of Investigational Products (IPs), or interfere with the interpretation of safety results

Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results

Exclusions Related to Investigational Products

Other concurrent/ongoing systemic investigational agents

Previous assignment to treatment during this study. Subjects permanently withdrawn from study treatment participation will not be allowed to re-enter the study.

History of severe allergic, anaphylactic or other hypersensitivity reactions attributed to murine or humanized antibodies or fusion protein, biopharmaceuticals produced in Chinese hamster ovary cell products, or compounds of similar chemical or biologic composition to platinum(s), PLD, Oregovomab or Nivolumab

Prior treatment with anti-CA 125 cancer vaccine, or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA 4) antibody or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.

Active, known or suspected autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Subjects with an autoimmune paraneoplastic syndrome requiring concurrent immunosuppressive treatment are excluded.

Active use of systemic corticosteroids (≥ 10mg/day prednisolone or equivalent) or other systemic immunosuppressive agents (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF) agents) within 7 days before study entry, or anticipated requirement for systemic immunosuppressive medications during the study, with the following exceptions:

1. Systemic corticosteroids at physiologic doses to treat adrenocortical insufficiency not to exceed 10 mg/day of prednisolone or equivalent

2. Steroids as premedication for hypersensitivity reactions (e.g. premedication for Carboplatin, PLD or CT contrast medium)

3. Intranasal, inhaled, ophthalmic topical glucocorticoids, local (e.g. intra-articular) steroid injections, and systemic mineralocorticoids (e.g. fludrocortisone)

History of solid organ allograft or allogeneic hematopoietic stem cell transplantation

Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness

Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen (HBsAg) test and a positive antibody to hepatitis B core antigen (anti-HBc) antibody test) are eligible. Patients with hepatitis B (HBV) infection (defined as having a positive HBsAg test) AND undetectable HBV DNA titer are also eligible.

Active tuberculosis

Administration of a live, attenuated vaccine within 4 weeks before study entry, or anticipation that such a live attenuated vaccine will be required during the study

Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity

Other Exclusions Criteria

\- Inability to attend or comply with treatment of follow-up scheduling

What this study is about