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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Aston Sci. Inc.
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Progression-Free Survival (PFS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Single blinded
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
AST-301
AST-201 with rhuGM-CSF (3-week interval, 3 cycles in total)
Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total)
* Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles
Intervention: AST-201 (Biological)
AST-301
AST-201 with rhuGM-CSF (3-week interval, 3 cycles in total)
Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total)
* Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles
Intervention: Paclitaxel (Drug)
AST-301
AST-201 with rhuGM-CSF (3-week interval, 3 cycles in total)
Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total)
* Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles
Intervention: Carboplatin (Drug)
AST-301
AST-201 with rhuGM-CSF (3-week interval, 3 cycles in total)
Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total)
* Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles
Intervention: rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor) (Drug)
Placebo
Placebo with rhuGM-CSF (3-week interval, 3 cycles in total)
Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total)
*Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles
Intervention: Paclitaxel (Drug)
Placebo
Placebo with rhuGM-CSF (3-week interval, 3 cycles in total)
Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total)
*Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles
Intervention: Carboplatin (Drug)
Placebo
Placebo with rhuGM-CSF (3-week interval, 3 cycles in total)
Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total)
*Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles
Intervention: Placebo (Drug)
Placebo
Placebo with rhuGM-CSF (3-week interval, 3 cycles in total)
Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total)
*Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles
Intervention: rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor) (Drug)
Outcomes
Primary Outcomes
Progression-Free Survival (PFS)
Time Frame: 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 Outcomes
- 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)
- 2-year PFS rate(24months from the first dose of AST-301 administration)
- Overall Survival (OS)(overall study duration (approximately 48 months))
- AST-201 specific immunogenicity by Interferon gamma (IFN-gamma) enzyme-linked immunospot (ELISpot )(17months)