Primary clear cell peritoneal carcinoma

This phase II trial compares the effect of folate receptor alpha dendritic cells (FRαDCs) to placebo in treating patients with stage III or IV ovarian, fallopian tube or primary peritoneal cancer. FRαDCs, a dendritic cell vaccine, is made from a person's white blood cells. The white blood cells are treated in the laboratory to make dendritic cells (a type of immune cell) mixed with folate receptor alpha (FRalpha), a protein found in high levels on ovarian tumor cells. FRαDCs work by boosting the immune system to recognize and destroy the tumor cells by targeting the FRalpha protein on the tumor cell. Placebo is an inactive substance that looks the same as, and is given the same way as, the active drug or treatment being tested. The effects of the active drug are compared to the effects of the placebo. Giving FRαDCs may work better in preventing or delaying recurrence compared to placebo in patients with stage III or IV ovarian, fallopian tube, or primary peritoneal cancer.

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.

主要目的： - 采用盲态独立评审委员会（BIRC）评估的客观缓解率（ORR）来确定CYH33单药治疗在具有PIK3CA热点突变的复发性或持续性卵巢、输卵管或原发性腹膜透明细胞癌患者中的有效性。将采用顺序检验依次评估主要目的，首先在具有PIK3CA外显子9突变的患者中进行评估，然后在所有PIK3CA热点突变的患者中进行评估。 次要目的： - 评价CYH33经BIRC评估的无进展生存期（PFS）、6个月PFS率、缓解持续时间（DoR）、至缓解的时间（TTR）和疾病控制率（DCR）方面的有效性。 - 评价CYH33经研究者评估的ORR、PFS、6个月PFS率、DoR、TTR和DCR方面的有效性。 - 评价总体生存期（OS）获益。