APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer and Malignant Effusion
Trial Parameters
Brief Summary
This phase II trial studies the effect of APL-2 when given in combination with either pembrolizumab or pembrolizumab and bevacizumab compared with bevacizumab alone in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent) and a buildup of fluid and cancer cells (malignant effusion). APL-2 may limit tumor progression, decrease malignant effusion production, and improve the immune system's response against cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving APL-2 together with either pembrolizumab or pembrolizumab and bevacizumab may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer and malignant effusion compared to bevacizumab alone.
Eligibility Criteria
Inclusion Criteria: * Age \>= 18 years of age on day of signing informed consent * Recurrent epithelial ovarian/fallopian tube or primary peritoneal cancer (serous, clear cell, endometrioid, mixed or poorly differentiated or carcinosarcoma) based on imaging or synchronous primary ovarian and uterine cancer patients with any of the histology subtypes mentioned above regardless of platinum sensitivity, prior stage or number of prior treatment lines * Symptomatic ascites or pleural effusion or both requiring \>= 1 drainage within 4-weeks of study entry or has a peritoneal/pleural drainage catheter in place to control symptoms * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Patient has not received pembrolizumab or other immune checkpoint inhibitor treatment for 9 weeks prior to enrollment * Life expectancy of \>= 3 months * Absolute neutrophil count (ANC): \>= 1,500/µL * Platelets: \>= 75,000/µL * Hemoglobin: \>= 9 g/dL or 5.6 mmol/L (within 7 days of asses