92 Participants Needed

Vigil Vaccine for Ovarian Cancer

(VITAL Trial)

Recruiting at 33 trial locations
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: Gradalis, Inc.
Must be taking: Platinum, Taxane
Prior Safety DataThis treatment has passed at least one previous human 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?

The Vigil vaccine, when combined with atezolizumab, was found to be safe in a study with ovarian cancer patients, with fewer severe treatment-related side effects compared to the alternative treatment sequence.12678

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

JN

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

I was able to care for myself before my surgery.
My cancer is not detectable after surgery and chemotherapy.
I started chemotherapy within 8 weeks after my initial surgery.
See 15 more

Exclusion Criteria

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.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

4-6 months
Monthly visits for injections

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

10 years

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
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Gradalis, Inc.

Lead Sponsor

Trials
16
Recruited
490+

Findings from Research

Recent trials have shown that antitumor vaccines can improve progression-free survival in breast cancer and overall survival in prostate cancer, marking a significant advancement in solid tumor vaccine therapy.
While no positive Phase III trials for ovarian cancer vaccines have been reported yet, ongoing improvements in target antigens and antigen presentation, along with new biological therapies, hold promise for enhancing vaccine efficacy in this area.
Ovarian cancer vaccine trials and tribulations.Buckanovich, RJ.[2019]
Ovarian cancer patients often face poor survival rates, with less than 40% surviving past 5 years, highlighting the urgent need for effective treatments like cancer vaccines that can stimulate T cell responses.
Using the murine ID8 ovarian tumor model, the study shows that combining cancer vaccines with standard treatments can enhance overall efficacy, suggesting a promising approach for improving outcomes in ovarian cancer patients.
Integrating Cancer Vaccines in the Standard-of-Care of Ovarian Cancer: Translating Preclinical Models to Human.Chiang, CL., Rovelli, R., Sarivalasis, A., et al.[2021]
The study developed a method to create synthetic oligopeptides from unique ovarian cancer biomarkers, which could lead to highly specific immune responses against ovarian cancer.
These oligopeptides are designed to be non-crossreactive, potentially enhancing their effectiveness for immunodiagnostics, immunoprevention, and immunotherapy in ovarian cancer treatment.
Oligopeptides for Immunotherapy Approaches in Ovarian Cancer Treatment.Kanduc, D.[2020]

References

Therapeutic vaccines for ovarian cancer. [2022]
Ovarian cancer vaccine trials and tribulations. [2019]
Immunological monitoring of anticancer vaccines in clinical trials. [2023]
Integrating Cancer Vaccines in the Standard-of-Care of Ovarian Cancer: Translating Preclinical Models to Human. [2021]
5.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Oligopeptides for Immunotherapy Approaches in Ovarian Cancer Treatment. [2020]
Development of Therapeutic Vaccines for Ovarian Cancer. [2020]
Long-term outcomes of patients with recurrent ovarian cancer treated with a polyvalent vaccine with bevacizumab combination. [2023]
Proof of principle study of sequential combination atezolizumab and Vigil in relapsed ovarian cancer. [2022]
A novel breast/ovarian cancer peptide vaccine platform that promotes specific type-1 but not Treg/Tr1-type responses. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Phase II study of Vigil® DNA engineered immunotherapy as maintenance in advanced stage ovarian cancer. [2017]
Efficacy and safety of Gemogenovatucel-T (Vigil) immunotherapy for advanced ovarian carcinoma: A systematic review and meta-analysis of randomized controlled trials. [2022]
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