Advanced Ovarian Cancer
Conditions
Keywords
cancer vaccine, phase 2 study, Advanced ovarian cancer, homologous-recombination proficient (HRP)
Brief 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).
Detailed 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.
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)
Sponsors
Aston Sci. Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single blinded
Intervention model description
Single blind, randomized, placebo-controlled, multicenter, phase 2 clinical study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-year PFS rate | 24months from the first dose of AST-301 administration | proportion of patients alive without disease progression or death at two years after the randomization |
| Overall Survival (OS) | overall study duration (approximately 48 months) | 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 ) | 17months | 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) | 5 months | 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 |
Countries
United States
Contacts
Primary ContactHyunwon Shin, MD, PhD
Backup ContactEunkyo Joung, MD, CMO
Outcome results
None listed