Cancer Vaccine for Ovarian Cancer

(Cornerstone4 Trial)

Overseen By Eunkyo Joung, MD, CMO

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Aston Sci. Inc.

Must not be taking: Immune suppressants

Disqualifiers: Active malignancy, Autoimmune disease, Infections, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 3

Duration: 5 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cancer vaccine, AST-201, for effectiveness and safety in individuals with advanced ovarian cancer not spread due to genetic factors. Participants will receive either the vaccine with a helper drug or a placebo, alongside standard chemotherapy. It suits those recently diagnosed with advanced ovarian cancer who have undergone successful surgery to remove most of their tumor and can begin additional treatment within six weeks. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immune suppression therapy, you must have stopped it at least 4 weeks before starting the trial.

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

Research shows that AST-201, the cancer vaccine under study, has helped shrink tumors in earlier trials. This suggests it might work well with other cancer treatments. However, specific safety information for AST-201 in humans is not yet available. As a phase 2 study, the treatment has passed initial safety tests, but researchers continue to assess its safety and effectiveness. This phase evaluates how well participants tolerate the treatment and identifies potential side effects. Joining this trial contributes to important research while doctors ensure participant safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about AST-201 for ovarian cancer because it represents a new approach to treatment. Unlike the standard of care, which typically involves chemotherapy drugs like paclitaxel and carboplatin, AST-201 is a cancer vaccine designed to stimulate the body's immune system to fight the cancer cells. This vaccine is given intradermally alongside a growth factor called rhuGM-CSF, which may enhance the immune response. By potentially improving the immune system's ability to target and destroy cancer cells, AST-201 offers a promising alternative to conventional treatments.

What evidence suggests that this cancer vaccine could be effective for ovarian cancer?

Research has shown that AST-201, a cancer vaccine, could improve outcomes for patients with newly diagnosed ovarian cancer that is homologous-recombination proficient (HRP). In earlier studies, AST-201 fought tumors in mice with ovarian cancer, indicating it might effectively target cancer cells. In this trial, participants in one arm will receive AST-201 with rhuGM-CSF, which boosts the immune system to attack cancer cells, potentially enhancing the effectiveness of standard chemotherapy treatments. Early results from similar trials suggest that combining AST-201 with a substance that increases white blood cell production might further improve treatment results. While more information from human trials is needed, these initial findings provide a strong basis for its potential use in treating ovarian cancer. ^{3 4 6 7 8}

Who Is on the Research Team?

Hyunwon Shin, MD, PhD

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

This trial is for patients with advanced stage III ovarian cancer who've had surgery to remove most of the tumor and can start follow-up therapy within 6 weeks. They must have a specific type of tumor (HRP) and be in good health overall, with no severe allergies to rhuGM-CSF, recent cancers except certain skin or epithelial cancers, autoimmune or inflammatory diseases, active infections like TB or hepatitis, HIV, nor be pregnant.

Inclusion Criteria

I am fully active or can carry out light work.

I can begin follow-up treatment within 6 weeks after my surgery to remove most of the cancer.

My organs are functioning well.

Exclusion Criteria

I do not have active infections like TB, hepatitis B, C, or HIV.

I have been on immune suppression therapy or stopped it less than 4 weeks ago.

I haven't had cancer, except for certain skin cancers, in the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive AST-201 with rhuGM-CSF or placebo with rhuGM-CSF in combination with standard adjuvant chemotherapy (Paclitaxel/Carboplatin) over approximately 5 months

5 months

Intradermal administration every 3 weeks for 3 cycles, chemotherapy every 3 weeks for 6 cycles

Follow-up

Survival follow-up performed every 3 months for 2 years after randomization and every 6 months thereafter until disease progression or death

48 months

Follow-up visits by telephone, in-person, or chart review

What Are the Treatments Tested in This Trial?

Interventions

• AST-201

Trial Overview

The study tests AST-201 (a therapeutic cancer vaccine) combined with rhuGM-CSF versus a placebo plus rhuGM-CSF. Both groups will also receive standard chemotherapy drugs Paclitaxel and Carboplatin. The goal is to see if AST-201 improves outcomes for those with newly diagnosed HRP ovarian cancer after surgery.

How Is the Trial Designed?

Group I: AST-301 Experimental Treatment 4 Interventions

AST-201 with rhuGM-CSF (3-week interval, 3 cycles in total) Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total) \* Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles

Group II: Placebo Placebo Group 4 Interventions

Placebo with rhuGM-CSF (3-week interval, 3 cycles in total) Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total) \*Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles

Who Is Running the Clinical Trial?

Aston Sci. Inc.

Lead Sponsor

Trials

4

Recruited

150+

Published Research Related to This Trial

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]

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]

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]

The heptavalent antigen-KLH plus QS21 vaccine was well tolerated in a pilot trial with 11 patients, showing only mild side effects like fatigue and localized reactions, with no significant safety concerns or evidence of autoimmunity.

The vaccine successfully induced antibody responses against five out of seven targeted cancer antigens, with most patients developing responses to at least three antigens, suggesting potential for further investigation in larger efficacy trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a heptavalent vaccine-keyhole limpet hemocyanin conjugate plus QS21 in patients with epithelial ovarian, fallopian tube, or peritoneal cancer. Sabbatini, PJ., Ragupathi, G., Hood, C., et al.[2017]

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]

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