Vigil Vaccine for Ovarian Cancer

(VITAL Trial)

Not currently recruiting at 33 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Gradalis, Inc.

Must be taking: Platinum, Taxane

Must not be taking: Immunosuppressants, Chronic steroids

Disqualifiers: Heart disease, Brain metastases, Autoimmune, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a treatment called Vigil can delay the return of ovarian, fallopian tube, or primary peritoneal cancer. Participants will receive either Vigil, a type of immunotherapy that uses the body's immune system to fight cancer, or a placebo, which has no active therapeutic effect. The study seeks women who have undergone successful surgery and chemotherapy for advanced stages of these cancers and are currently disease-free. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Vigil immunotherapy is generally easy for patients to handle. In one study, seven patients experienced serious health issues, but none were directly caused by the treatment. This indicates that while side effects can occur, they are neither common nor severe. Another study found that Vigil was well-tolerated by patients with advanced ovarian cancer. Importantly, no deaths related to the treatment were reported, offering reassurance to those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this possible treatment for ovarian cancer?

Unlike the standard treatments for ovarian cancer, which often include chemotherapy and surgery, the Vigil vaccine is unique because it harnesses the body's immune system to fight cancer. It works as an immunotherapy, aiming to train the immune system to recognize and destroy cancer cells more effectively. Researchers are particularly excited about Vigil because it could offer a more targeted approach, potentially leading to fewer side effects and enhanced long-term outcomes compared to conventional therapies. Plus, its administration through intradermal injection every four weeks provides a straightforward and potentially more convenient treatment regimen.

What evidence suggests that Vigil might be an effective treatment for ovarian cancer?

In this trial, participants will receive either Vigil immunotherapy or a placebo. Studies have shown that Vigil immunotherapy can effectively treat ovarian cancer. Research indicates that it can significantly improve overall survival and delay cancer recurrence, particularly in patients with advanced ovarian cancer who lack the BRCA gene mutation. One study found that Vigil was well tolerated and benefited patients with specific genetic profiles, such as those without the BRCA mutation and those with normal DNA repair function. Another study found that patients receiving Vigil experienced an average of 8.2 months before cancer worsened and lived an average of 18.5 months overall. These findings suggest that Vigil may help delay cancer recurrence and improve survival in certain ovarian cancer patients. ^{1 2 3 6 7}

Who Is on the Research Team?

John Nemunaitis, MD

Principal Investigator

Gradalis, Inc.

Are You a Good Fit for This Trial?

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

My cancer is not detectable after surgery and chemotherapy.

I was able to care for myself before my surgery.

I started chemotherapy within 8 weeks after my initial surgery.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Group A Active Control 1 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 B Placebo Group 1 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.

Who Is Running the Clinical Trial?

Gradalis, Inc.

Lead Sponsor

Trials

16

Recruited

490+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oligopeptides for Immunotherapy Approaches in Ovarian Cancer Treatment. Kanduc, D.[2020]

The study involved 21 patients with high-grade serous ovarian cancer treated with a vaccine and bevacizumab, showing that the treatment was generally well tolerated, with only one case of severe toxicity and a small percentage experiencing significant side effects.

While the vaccine induced an immunogenic response in a majority of patients, this response did not correlate with improved survival outcomes, although increased levels of IL-8 were linked to better progression-free survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes of patients with recurrent ovarian cancer treated with a polyvalent vaccine with bevacizumab combination. Kahn, RM., Ragupathi, G., Zhou, QC., et al.[2023]

The combination of the Vigil vaccine and atezolizumab was found to be safe for patients with relapsed ovarian cancer, with no dose-limiting toxicities reported in the initial safety assessment involving 3 patients.

Patients receiving the Vigil vaccine first (Vigil-1st) showed a significantly improved median overall survival compared to those starting with atezolizumab (Atezo-1st), with a hazard ratio of 0.33, indicating a potential benefit for further investigation, especially in BRCA wild-type patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proof of principle study of sequential combination atezolizumab and Vigil in relapsed ovarian cancer. Rocconi, RP., Stevens, EE., Bottsford-Miller, JN., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9634109/

Efficacy and safety of Gemogenovatucel-T (Vigil) ... This study found that Gemogenovatucel-T (Vigil) immunotherapy provided significant OS and RFS benefits, particularly in advanced OC patients with BRCA wild type ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.5502

Maintenance vigil immunotherapy in newly diagnosed ... Vigil immunotherapy as frontline maintenance in Stage III/IV ovarian cancer is well tolerated and showed clinical benefit in both BRCA-wt and HRP molecular ...

3. asco.org asco.org/abstracts-presentations/ABSTRACT335709

Maintenance vigil immunotherapy in newly diagnosed ... Maintenance vigil immunotherapy in newly diagnosed advanced ovarian cancer: Efficacy assessment of homologous recombination proficient (HRP) patients in the ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24091667

15 Randomized double-blind placebo controlled trial of ... Vigil immunotherapy as 1L maintenance in Stage III/IV ovarian cancer is well tolerated and showed significant RFS clinical benefit, particularly in BRCA1/2 ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/14796694.2024.2376518

Full article: Gemogenovatucel-T (Vigil): bi-shRNA plasmid- ... Comparatively, the 8 patients receiving Vigil/TEM/IRI demonstrated median PFS of 8.2 months and median OS of 18.5 months. Results justify ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01309230

A Trial of FANG™ Vaccine for Participants With Ovarian ... Vigil is considered an immunotherapy. In this study, participants who met the requirements to be in the study and if Vigil was successfully made from the ...

7. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30533-7/abstract

Gemogenovatucel-T (Vigil) immunotherapy as ... Seven patients (four in the placebo group and three in the gemogenovatucel-T group) had 11 serious adverse events. No treatment-related deaths were reported in ...