Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AST-201, Paclitaxel, Carboplatin, Placebo.
- Who it may be relevant to
- Registry conditions: Advanced Ovarian Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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
- Biological AST-201
i.d. (3-week interval, 3 cycles in total) - Drug Paclitaxel
3-week interval, 6 cycles in total - Drug Carboplatin
3-week interval, 6 cycles in total - Drug Placebo
i.d. (3-week interval, 3 cycles in total) - Drug rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)
i.d. (3-week interval, 3 cycles in total)
Primary outcome measures
- Progression-Free Survival (PFS) [Time frame: overall study duration (approximately 48 months)]
Secondary outcome measures (4)
- 2-year PFS rate [Time frame: 24months from the first dose of AST-301 administration]
- Overall Survival (OS) [Time frame: overall study duration (approximately 48 months)]
- AST-201 specific immunogenicity by Interferon gamma (IFN-gamma) enzyme-linked immunospot (ELISpot ) [Time frame: 17months]
- Number of participants with Adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0) [Time frame: 5 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Washington — Seattle
Identifiers
NCT: NCT05794659 · PN-201-22