AST-201: i.d. (3-week interval, 3 cycles in total)
Paclitaxel: 3-week interval, 6 cycles in total
Carboplatin: 3-week interval, 6 cycles in total
Placebo: i.d. (3-week interval, 3 cycles in total)
rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor): i.d. (3-week interval, 3 cycles in total)
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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 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
Primary outcome measure(s)
Progression-Free Survival (PFS) — overall study duration (approximately 48 months) the time from the date of randomization to disease progression, or death from any cause whichever occurs first
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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