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

98 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this phase 2 study is to assess the efficacy and safety for adjuvant therapeutic cancer vaccine AST-201 (pUMVC3-hIGFBP-2) in patients with newly diagnosed homologous-recombination proficient(HRP) advanced ovarian cancer (Stage III) after debulking surgery. Patients will receive AST-201 with rhuGM-CSF(Colony Stimulating Factor) or placebo with rhuGM-CSF in combination with standard adjuvant chemotherapy(Paclitaxel/Carboplatin).

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.

What data supports the effectiveness of the treatment AST-201 for ovarian cancer?

Research shows that cancer vaccines, which aim to stimulate the body's immune system to fight cancer, have shown promise in improving outcomes for ovarian cancer patients. Although specific data on AST-201 is not provided, similar vaccines have demonstrated benefits in other cancers, like breast and prostate cancer, suggesting potential effectiveness in ovarian cancer as well. ^{1 2 3 4 5}

Is the cancer vaccine for ovarian cancer, including AST-201, generally safe for humans?

The research discusses various cancer vaccines for ovarian cancer, but it does not provide specific safety data for AST-201 or similar treatments. However, it mentions that some trials have shown positive outcomes in other cancers, suggesting potential safety, but specific safety data for ovarian cancer vaccines is not detailed. ^{2 3 4 5 6}

How is the cancer vaccine treatment for ovarian cancer different from other treatments?

This cancer vaccine treatment is unique because it aims to stimulate the body's immune system to specifically target ovarian cancer cells by using antigens (substances that trigger an immune response) uniquely expressed in ovarian cancer. Unlike traditional treatments, it focuses on enhancing the body's natural defenses to fight the cancer, potentially offering a more targeted and less invasive approach. ^{1 2 4 5 7}

Research Team

Hyunwon Shin, MD, PhD

Principal Investigator

[e-mail]

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Therapeutic vaccines for ovarian cancer. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Ovarian cancer vaccine trials and tribulations. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Long-term outcomes of patients with recurrent ovarian cancer treated with a polyvalent vaccine with bevacizumab combination. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Integrating Cancer Vaccines in the Standard-of-Care of Ovarian Cancer: Translating Preclinical Models to Human. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Personalized cancer vaccine strategy elicits polyfunctional T cells and demonstrates clinical benefits in ovarian cancer. [2023]

7. United States 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. [2017]