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)
Aston Sci. Inc.
Summary
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).
Description
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 cons…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Demonstrates adequate organ function. Exclusion Criteria: * Has a history of hypersensitivity or other contraindications to rhuG…
Interventions
- BiologicalAST-201
i.d. (3-week interval, 3 cycles in total)
- DrugPaclitaxel
3-week interval, 6 cycles in total
- DrugCarboplatin
3-week interval, 6 cycles in total
- DrugPlacebo
i.d. (3-week interval, 3 cycles in total)
- DrugrhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)
i.d. (3-week interval, 3 cycles in total)
Location
- University of WashingtonSeattle, Washington