Ovarian Cancer Clinical Trial
Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer
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).
Full 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 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.
Eligibility Criteria
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 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
Has active infectious disease including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study
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There is 1 Location for this study
Seattle Washington, 98109, United States More Info
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