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Vigil Vaccine for Ovarian Cancer (VITAL Trial)
VITAL Trial Summary
This trial is testing whether a vaccine made from a person's own tumor cells can help keep ovarian cancer from coming back.
VITAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVITAL Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.VITAL Trial Design
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Who is running the clinical trial?
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- I was able to care for myself before my surgery.My cancer is not detectable after surgery and chemotherapy.I have HIV or chronic Hepatitis B or C.My cancer is a specific type that affects the uterus.I have serious heart issues, including recent heart failure, unstable chest pain, or a recent heart attack.I started chemotherapy within 8 weeks after my initial surgery.At least 4 doses of my treatment and placebo have been successfully made.You have a past or current autoimmune disease.My cancer is advanced ovarian, fallopian tube, or peritoneal and confirmed by a biopsy.I have been cancer-free from any other type of cancer for at least 2 years.I have recovered from side effects of my previous treatments.I am a woman aged 18 or older.You have never had a bad reaction to taxane or platinum drugs before.I have not taken immunosuppressive drugs in the last 14 days.You have a mental illness or social issues that might make it hard for you to follow the study rules.I have had brain metastases.I have advanced ovarian, fallopian tube, or peritoneal cancer.I have had a solid organ or bone marrow transplant.You have not had any allergic reactions to gentamicin in the past.My organs and bone marrow are functioning normally.I haven't had surgery, radiotherapy, immunotherapy, or experimental treatments in the last 4 weeks.I haven't received chemotherapy or experimental drugs before tissue collection for Vigil.I've had surgery for ovarian cancer and 5-8 rounds of specific chemotherapy.I am not on long-term steroids or immunosuppressants, except for short-term or inhaled ones.I am expected to provide about 30 grams of tissue during my surgery.I am fully active or can carry out light work.
- Group 1: Group A
- Group 2: Group B
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many distinct sites are administering this clinical trial?
"Patients may find this trial at the University of Kentucky in Lexington, GHS Cancer Institute in Greenville and Augusta University in Augusta. Additionally, 33 additional sites are recruiting participants for this research project."
Are there still openings for those wishing to participate in this experiment?
"The clinical trial in question is no longer recruiting participants, as evidenced by the last update being dated May 25th 2022. However, according to information hosted on ClinicalTrials.gov, there are currently 677 other medical trials actively seeking patients."
Has Group A been given the green light from the FDA?
"After considering the available evidence, our team at Power rated Group A's safety a 2 because while there is some data confirming its security, Phase 2 trials do not yet provide proof of efficacy."
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