The purpose of this phase 2 study is to assess the efficacy and safety for adjuvant therapeutic cancer vaccine AST-201 (pUMVC3-hIGFBP-2) in patients with newly diagnosed homologous-recombination proficient(HRP) advanced ovarian cancer (Stage III) after debulking surgery. Patients will receive AST-201 with rhuGM-CSF(Colony Stimulating Factor) or placebo with rhuGM-CSF in combination with standard adjuvant chemotherapy(Paclitaxel/Carboplatin).
Newly diagnosed stage III (FIGO classification) epithelial ovarian cancer including primary peritoneal cancer, fallopian-tube cancer
Has received upfront surgery and optimally debulked(a residual tumor less than 1 cm)
Can start adjuvant therapy within 6 weeks of debulking surgery
Has Homologous Recombination Proficiency (HRP) tumor defined by FDA-approved testing
Has a history of hypersensitivity or other contraindications to rhuGM-CSF
Has a history of active malignancy ≤5 years prior to first administration of investigational drug except for adequately treated non-melanoma skin cancer or epithelial carcinoma without evidence of disease
Is on immune suppression therapy or has a history of immune suppression therapy ≤4 weeks prior to the first administration of investigational drugs
Has active or prior autoimmune disease or inflammatory disease
Parallel
AST-201
Biological/Vaccinei.d. (3-week interval, 3 cycles in total)
Paclitaxel
Drug3-week interval, 6 cycles in total
Carboplatin
Drug3-week interval, 6 cycles in total
Placebo
Drugi.d. (3-week interval, 3 cycles in total)
rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)
Drugi.d. (3-week interval, 3 cycles in total)
Progression-Free Survival (PFS)
the time from the date of randomization to disease progression, or death from any cause whichever occurs first
2-year PFS rate
proportion of patients alive without disease progression or death at two years after the randomization
Overall Survival (OS)
the time from the date of randomization to death from any cause
AST-201 specific immunogenicity by Interferon gamma (IFN-gamma) enzyme-linked immunospot (ELISpot )
AST-201 specific IFN-gamma ELISpot
Number of participants with Adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0)
Adverse events (AEs) Treatment-emergent adverse events (TEAEs) Serious adverse events (SAEs) Vital signs Physical examination Eastern Cooperative Oncology Group (ECOG) performance status Electrocardiogram (ECG) test Laboratory tests
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