Advanced Ovarian Cancer Clinical Trial
Official title:
A Randomized Phase 2 Study to Evaluate the Efficacy and Safety for Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer (Cornerstone-004)
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).
The study will comprise a screening period of -28 Days prior to initiation of study treatment (Day 1); an enrollment period of 24 months; the treatment duration will be approximately of 5 months. The study will evaluate whether the addition of AST-201/rhuGM-CSF to the standard adjuvant chemotherapy will extend the Progression Free Survival(PFS) rate. Survival follow-up will be performed every 3 months (±14 days) after the End of treatment (EOT) visit for 2 years after randomization and every 6 months (±28 days) thereafter until disease progression or death from any cause or withdrawal of consent whichever comes first. Survival follow-up visits will be conducted by telephone, in-person visit, or chart review. The end of study (EOS) is defined as 2 years after the date of last patient enrollment. ;
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