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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

Clinically defined complete response (cCR) following completion of primary surgical debulking and eligible chemotherapy

Subjects must have initiated adjuvant chemotherapy no more than 8 weeks following primary debulking surgery

Must not have

Histologically confirmed papillary serous adenocarcinoma of the uterus or disease involving myometrium/endometrium

Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months)

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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 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 fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is a specific type that affects the uterus.

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I have serious heart issues, including recent heart failure, unstable chest pain, or a recent heart attack.

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I have HIV or chronic Hepatitis B or C.

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I have not taken immunosuppressive drugs in the last 14 days.

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I have had brain metastases.

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I have had a solid organ or bone marrow transplant.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recurrence Free Survival (RFS)

Secondary study objectives

Overall survival (OS)

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.

0 / 16Eligibility criteria met