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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presumptive Stage IIIb, IIIc or IV high-grade papillary serous/clear cell/endometrioid ovarian, fallopian tube or primary peritoneal cancer.
Histologically confirmed Stage IIIb, IIIc or IV high-grade papillary serous/clear cell/endometrioid ovarian, fallopian tube or primary peritoneal.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upos 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.
Eligible Conditions
- Ovarian Cancer
- Ovarian Tumors
VITAL Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have never had an allergic reaction to taxanes or platinum-based drugs.
VITAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ os will be evaluated from time of randomization until date of death can be obtained, assessed up to 10 years.
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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had cancer that has spread to your brain in the past.You have never had an allergic reaction to taxanes or platinum-based drugs.You have severe heart problems, such as congestive heart failure or unstable angina. You have also had a stroke or heart attack in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group B
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
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
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