Phase II Randomized Trial of Nivolumab With or Without Ipilimumab in Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
This randomized phase II trial studies how well nivolumab works with or without ipilimumab in treating patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer that has not responded after prior treatment (persistent) or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
• Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer with documented disease progression (disease not amendable to curative therapy); histologic confirmation of the original primary tumor is required via the pathology report; NOTE: patients with mucinous histology are NOT eligible; patients with carcinosarcoma histology are NOT eligible
• All patients must have measurable disease as defined by RECIST 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be \>= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or \>= 20 mm when measured by chest x-ray; lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI
• Patients must have at least one target lesion to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as non-target lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
• Appropriate for study entry based on the following diagnostic workup:
‣ History/physical examination within 28 days prior to registration
⁃ Imaging of target lesion(s) within 28 days prior to registration
⁃ Further protocol-specific assessments:
• Recovery from effects of recent surgery, radiotherapy or chemotherapy
∙ Free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection \[UTI\])
∙ Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
∙ Any other prior therapy directed at the malignant tumor including chemotherapy, targeted agents, immunologic agents, and any investigational agents, must be discontinued at least 4 weeks prior to registration (6 weeks for nitrosoureas or mitomycin C)
∙ Any prior radiation therapy must be completed at least 4 weeks prior to registration
∙ At least 4 weeks must have elapsed since major surgery
• Patients are allowed to have received up to three prior cytotoxic regimens for treatment of their epithelial ovarian, fallopian tube, or primary peritoneal cancer; they must have had one prior platinum-based chemotherapeutic regimen for management of primary disease, possibly including intra-peritoneal therapy, consolidation, biologic/targeted (non-cytotoxic) agents or extended therapy (maintenance/consolidation) administered after surgical or non-surgical assessment; patients are allowed to have received, but are not required to have received, one to two cytotoxic regimens for management of recurrent or persistent disease; (for the purposes of this study poly adenosine diphosphate \[ADP\] ribose polymerase \[PARP\] inhibitors given for recurrent or progressive disease will be considered cytotoxic; PARP inhibitors given as maintenance therapy in continuation with management of primary disease will not be considered as a separate cytotoxic regimen); if two cytotoxic regimens had been received for management of recurrent or persistent disease, one of these regimens would have had to contain either a platinum or a taxane agent
• Performance status of 0, 1 or 2 within 28 days prior to registration
• Absolute neutrophil count (ANC) \>= 1,500/ul (within 14 days prior to registration)
• Platelets \>= 100,000/ul (within 14 days prior to registration)
• Creatinine =\< 1.5 x institutional/laboratory upper limit of normal (ULN) (within 14 days prior to registration)
• Bilirubin =\< 1.5 x ULN; for patients with Gilbert's syndrome, bilirubin =\< 3.0 mg/dL is acceptable (within 14 days prior to registration)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN (within 14 days prior to registration)
• Albumin \>= 2.8 g/dL (within 14 days prior to registration)
• Adequate thyroid function within 28 days prior to registration defined as serum thyroid-stimulating hormone (TSH) in normal range
• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
• Platinum-free interval (PFI) - patients must have progressed \< 12 months after completion of their last platinum-based chemotherapy; the date (platinum free interval) should be calculated from the last administered dose of platinum therapy to documentation of progression
• Adequate oxygen saturation via pulse oximeter within 28 days prior to registration (i.e., patient can NOT have CTCAE hypoxia grade 2 or greater)
• Left ventricular ejection fraction (LVEF) \>= 50% (measured within 28 days of study entry)