Vigil Vaccine for Ovarian Cancer
(VITAL Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressive therapy or chronic steroids, you may need to stop them before joining the trial.
What data supports the effectiveness of the Vigil Vaccine treatment for ovarian cancer?
Research shows that cancer vaccines, like the Vigil Vaccine, can trigger immune responses that target cancer cells, and there is evidence that these immune responses are linked to better outcomes in some cancer patients. Although no Phase III trials have shown a clear benefit for ovarian cancer yet, improvements in vaccine design and understanding of the immune system are promising for future success.12345
Is the Vigil vaccine safe for humans?
How is the Vigil treatment different from other ovarian cancer treatments?
Vigil is a personalized vaccine that uses a patient's own tumor cells to enhance the immune system's response against ovarian cancer, making it unique compared to standard treatments. It works by increasing tumor neoantigen expression and controlling immune-suppressing factors, which may improve survival, especially in patients without BRCA mutations.1891011
What is the purpose of this trial?
The goal of this clinical trial is to compare participants with ovarian, fallopian tube or primary peritoneal cancer when treated with investigational product (Vigil) compared to placebo. The main question it aims to answer is "Will participants who receive treatment with Vigil have a longer time to disease recurrence versus the participants that were not given Vigil?"
Research Team
John Nemunaitis, MD
Principal Investigator
Gradalis, Inc.
Eligibility Criteria
This trial is for women aged 18 or older with Stage IIIb, IIIc, or IV high-grade ovarian, fallopian tube, or primary peritoneal cancer. They must have completed surgery and chemotherapy without prior hypersensitivity to those treatments and be in clinical complete response. Participants need normal organ function and no history of certain diseases like autoimmune disorders or recent heart issues.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Vigil or placebo by intradermal injection every 4 weeks for a minimum of 4 and up to a maximum of 6 doses
Follow-up
Participants are monitored for disease recurrence and overall survival with imaging assessments every 3 months in Years 1-3, every 6 months in Years 4-5, and yearly through Year 10
Long-term follow-up
Participants enter long-term follow-up for survival status and post-treatment therapies received upon recurrence
Treatment Details
Interventions
- Placebo
- Vigil
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gradalis, Inc.
Lead Sponsor