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Vigil Vaccine for Ovarian Cancer (VITAL Trial)

Phase 2
Waitlist Available
Research Sponsored by Gradalis, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status (PS) 0-2 prior to diagnostic laparoscopy or debulking laparotomy
Clinically defined complete response (cCR) following completion of primary surgical debulking and eligible chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up os will be evaluated from time of randomization until date of death can be obtained, assessed up to 10 years.
Awards & highlights

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.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests Vigil, an investigational product against a placebo in patients who've had ovarian-related cancers. It aims to see if Vigil extends the time before the disease comes back compared to not receiving it. Patients are randomly assigned to receive either Vigil or a placebo.See study design
What are the potential side effects?
While specific side effects for Vigil aren't listed here, common ones for cancer trials may include fatigue, nausea, allergic reactions, and potential impacts on immune function which could increase infection risk.

VITAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was able to care for myself before my surgery.
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My cancer is not detectable after surgery and chemotherapy.
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I started chemotherapy within 8 weeks after my initial surgery.
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At least 4 doses of my treatment and placebo have been successfully made.
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My cancer is advanced ovarian, fallopian tube, or peritoneal and confirmed by a biopsy.
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I have been cancer-free from any other type of cancer for at least 2 years.
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I have recovered from side effects of my previous treatments.
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I am a woman aged 18 or older.
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I have advanced ovarian, fallopian tube, or peritoneal cancer.
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My organs and bone marrow are functioning normally.
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I haven't received chemotherapy or experimental drugs before tissue collection for Vigil.
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I've had surgery for ovarian cancer and 5-8 rounds of specific chemotherapy.
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I am expected to provide about 30 grams of tissue during my surgery.
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I am fully active or can carry out light work.

VITAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~os will be evaluated from time of randomization until date of death can be obtained, assessed up to 10 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and os will be evaluated from time of randomization until date of death can be obtained, assessed up to 10 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrence Free Survival (RFS)
Secondary outcome measures
Overall survival (OS)

VITAL Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Group AActive Control1 Intervention
Vigil immunotherapy will be administered at a concentration of 1.0 x 10e7 cells/dose given via intradermal injection every 4 weeks for a minimum of 4 and a maximum of 6 administrations as determined by the number of doses manufactured and as long as the subject is clinically stable and recurrence free.
Group II: Group BPlacebo Group1 Intervention
Placebo will be administered via intradermal injection every 4 weeks for a minimum of 4 and a maximum of 6 administrations as determined by the number of doses manufactured and as long as the subject is clinically stable and recurrence free.

Find a Location

Who is running the clinical trial?

Gradalis, Inc.Lead Sponsor
15 Previous Clinical Trials
393 Total Patients Enrolled
4 Trials studying Ovarian Cancer
183 Patients Enrolled for Ovarian Cancer
John Nemunaitis, MDStudy DirectorGradalis, Inc.
11 Previous Clinical Trials
400 Total Patients Enrolled
4 Trials studying Ovarian Cancer
199 Patients Enrolled for Ovarian Cancer
Luisa Manning, MDStudy DirectorGradalis, Inc.
7 Previous Clinical Trials
88 Total Patients Enrolled
2 Trials studying Ovarian Cancer
25 Patients Enrolled for Ovarian Cancer

Media Library

Group A Clinical Trial Eligibility Overview. Trial Name: NCT02346747 — Phase 2
Ovarian Cancer Research Study Groups: Group A, Group B
Ovarian Cancer Clinical Trial 2023: Group A Highlights & Side Effects. Trial Name: NCT02346747 — Phase 2
Group A 2023 Treatment Timeline for Medical Study. Trial Name: NCT02346747 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
~14 spots leftby Dec 2025