Cancer Vaccine for Ovarian Cancer
(Cornerstone4 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new cancer vaccine, AST-201, for effectiveness and safety in individuals with advanced ovarian cancer not spread due to genetic factors. Participants will receive either the vaccine with a helper drug or a placebo, alongside standard chemotherapy. It suits those recently diagnosed with advanced ovarian cancer who have undergone successful surgery to remove most of their tumor and can begin additional treatment within six weeks. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on immune suppression therapy, you must have stopped it at least 4 weeks before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that AST-201, the cancer vaccine under study, has helped shrink tumors in earlier trials. This suggests it might work well with other cancer treatments. However, specific safety information for AST-201 in humans is not yet available. As a phase 2 study, the treatment has passed initial safety tests, but researchers continue to assess its safety and effectiveness. This phase evaluates how well participants tolerate the treatment and identifies potential side effects. Joining this trial contributes to important research while doctors ensure participant safety.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about AST-201 for ovarian cancer because it represents a new approach to treatment. Unlike the standard of care, which typically involves chemotherapy drugs like paclitaxel and carboplatin, AST-201 is a cancer vaccine designed to stimulate the body's immune system to fight the cancer cells. This vaccine is given intradermally alongside a growth factor called rhuGM-CSF, which may enhance the immune response. By potentially improving the immune system's ability to target and destroy cancer cells, AST-201 offers a promising alternative to conventional treatments.
What evidence suggests that this cancer vaccine could be effective for ovarian cancer?
Research has shown that AST-201, a cancer vaccine, could improve outcomes for patients with newly diagnosed ovarian cancer that is homologous-recombination proficient (HRP). In earlier studies, AST-201 fought tumors in mice with ovarian cancer, indicating it might effectively target cancer cells. In this trial, participants in one arm will receive AST-201 with rhuGM-CSF, which boosts the immune system to attack cancer cells, potentially enhancing the effectiveness of standard chemotherapy treatments. Early results from similar trials suggest that combining AST-201 with a substance that increases white blood cell production might further improve treatment results. While more information from human trials is needed, these initial findings provide a strong basis for its potential use in treating ovarian cancer.34678
Who Is on the Research Team?
Hyunwon Shin, MD, PhD
Principal Investigator
hyunwon.shin@astonsci.com
Are You a Good Fit for This Trial?
This trial is for patients with advanced stage III ovarian cancer who've had surgery to remove most of the tumor and can start follow-up therapy within 6 weeks. They must have a specific type of tumor (HRP) and be in good health overall, with no severe allergies to rhuGM-CSF, recent cancers except certain skin or epithelial cancers, autoimmune or inflammatory diseases, active infections like TB or hepatitis, HIV, nor be pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AST-201 with rhuGM-CSF or placebo with rhuGM-CSF in combination with standard adjuvant chemotherapy (Paclitaxel/Carboplatin) over approximately 5 months
Follow-up
Survival follow-up performed every 3 months for 2 years after randomization and every 6 months thereafter until disease progression or death
What Are the Treatments Tested in This Trial?
Interventions
- AST-201
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aston Sci. Inc.
Lead Sponsor