Cancer Vaccine for Ovarian Cancer

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: Mayo Clinic

Must be taking: Platinum-based chemotherapy

Must not be taking: Antiretrovirals, Immunosuppressants, Steroids

Disqualifiers: HIV, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

19 Participants Needed

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, you cannot be on immunosuppressive therapy or systemic steroids within 4 weeks before joining the trial.

What data supports the effectiveness of the treatment Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine, FRalphaDC, for ovarian cancer?

Research shows that a similar vaccine using dendritic cells loaded with folate receptor alpha (FRα) antigens is safe and can trigger immune responses that are linked to longer periods without cancer returning in ovarian cancer patients. Additionally, a study on a multipeptide vaccine showed it was safe and could stimulate immune responses in patients with advanced ovarian cancer. ^{1 2 3 4 5}

Is the cancer vaccine for ovarian cancer safe for humans?

The cancer vaccine for ovarian cancer, including the Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine, has been tested in clinical trials and found to be safe, with no severe side effects reported. Most side effects were mild, such as injection site reactions and fatigue. ^{1 2 3 6 7}

How does the cancer vaccine for ovarian cancer differ from other treatments?

This cancer vaccine is unique because it uses the patient's own dendritic cells (a type of immune cell) to stimulate a specific immune response against the folate receptor alpha, a protein often found in ovarian cancer cells. This approach aims to enhance the body's natural ability to fight cancer by promoting both cellular and antibody responses, potentially leading to prolonged remission. ^{1 2 3 6 8}

What is the purpose of this trial?

This pilot clinical trial studies the safety and immunogenicity of vaccine therapy in treating patients with stage IIIC-IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer following surgery and chemotherapy. Vaccines made from a person's peptide treated white blood cells may help the body build an effective immune response to kill tumor cells.

Research Team

Matthew S. Block, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who've had surgery and one round of chemo. They should have no signs of disease currently, be in good physical condition, able to consent, return for follow-ups at Mayo Clinic Rochester, provide blood samples, get a tetanus shot and live more than 6 months.

Inclusion Criteria

I had surgery to reduce my tumor and finished one round of platinum-based chemotherapy between 4 to 20 weeks ago.

You are willing to give blood samples for tests to check your immune system and other health factors.

My cancer diagnosis is advanced ovarian, fallopian tube, or peritoneal cancer.

Exclusion Criteria

I haven't had any cancer except for skin cancer or cervical pre-cancer in the last 3 years.

I had a heart attack less than 6 months ago or have heart failure needing constant treatment.

My ovarian cancer is of a type that grows slowly.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Phase

Patients receive folate receptor alpha peptide-loaded dendritic cell vaccine intradermally on day 1. Treatment repeats every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.

15 weeks

5 visits (in-person)

Maintenance Phase

Patients receive folate receptor alpha peptide-loaded dendritic cell vaccine intradermally on day 1. Treatment repeats every 3 months for 7 courses in the absence of disease progression or unacceptable toxicity.

21 months

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Every 3-6 months

Treatment Details

Interventions

• Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine

Trial Overview The study tests the safety and immune response to a vaccine therapy made from the patient's own white blood cells treated with peptides. It targets women with stage IIIC-IV ovarian epithelial cancer post-surgery and chemotherapy.

Participant Groups

Group I: Treatment (vaccine therapy) Experimental Treatment 2 Interventions

INDUCTION PHASE: Patients receive folate receptor alpha peptide-loaded dendritic cell vaccine ID on day 1. Treatment repeats every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive folate receptor alpha peptide-loaded dendritic cell vaccine ID on day 1. Treatment repeats every 3 months for 7 courses in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

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]

The phase I clinical trial involving 19 ovarian cancer patients demonstrated that a vaccine using Th17-inducing dendritic cells is safe, with no severe adverse events reported, and successfully induces immune responses against the folate receptor alpha (FRα).

Of the 18 patients evaluated for efficacy, 39% remained recurrence-free after a median follow-up of 49.2 months, suggesting that the vaccine may contribute to prolonged remission in ovarian cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Th17-inducing autologous dendritic cell vaccination promotes antigen-specific cellular and humoral immunity in ovarian cancer patients. Block, MS., Dietz, AB., Gustafson, MP., et al.[2020]

In a phase 1 study involving 9 participants with ovarian cancer, a peptide-based vaccine was found to be safe, with all reported side effects being mild (grade 1 to 2), including injection site reactions and fatigue.

The vaccine elicited T-cell responses in 89% of participants after stimulation, indicating immunogenicity, but the responses were of low potency, suggesting that future studies may need to combine this vaccine with additional immunomodulatory treatments to enhance T-cell activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multipeptide vaccine is safe and elicits T-cell responses in participants with advanced stage ovarian cancer. Chianese-Bullock, KA., Irvin, WP., Petroni, GR., et al.[2020]

The phase I clinical trial demonstrated that a vaccine targeting the folate receptor alpha (FR) is safe and well-tolerated in patients with ovarian or breast cancer, with over 90% of participants showing an immune response after vaccination.

Immunity to the FR developed slowly, reaching its peak around 5 months after vaccination, but persisted for at least 12 months, indicating the potential for long-lasting immune protection against tumors expressing FR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Folate Receptor Alpha Peptide Vaccine Generates Immunity in Breast and Ovarian Cancer Patients. Kalli, KR., Block, MS., Kasi, PM., et al.[2023]

Dendritic cell (DC) vaccines have shown promising clinical benefits and safety in phase II trials for treating epithelial ovarian cancer (EOC), which is a leading cause of gynecologic cancer deaths.

Currently, DC vaccines are being evaluated in a phase III clinical trial, indicating a significant step towards potentially improving treatment options for EOC patients who have limited chemotherapy choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced clinical trials of dendritic cell vaccines in ovarian cancer. Guo, Q., Yang, Q., Li, J., et al.[2021]

The study identifies the human high-affinity folate binding protein (FBP) as a promising target for cancer immunotherapy, showing that its antigenic peptides can stimulate immune responses in both ovarian and breast cancers.

FBP peptides enhance the cytotoxic activity of tumor-associated lymphocytes against various epithelial tumors, indicating their potential for developing a broadly applicable vaccine for multiple types of epithelial-derived cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccine implications of folate binding protein, a novel cytotoxic T lymphocyte-recognized antigen system in epithelial cancers. Peoples, GE., Anderson, BW., Lee, TV., et al.[2020]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

Th17-inducing autologous dendritic cell vaccination promotes antigen-specific cellular and humoral immunity in ovarian cancer patients. [2020]

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

A multipeptide vaccine is safe and elicits T-cell responses in participants with advanced stage ovarian cancer. [2020]

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

Transimmunization restores immune surveillance and prevents recurrence in a syngeneic mouse model of ovarian cancer. [2021]

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

Therapeutic vaccines for ovarian cancer. [2022]

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

Folate Receptor Alpha Peptide Vaccine Generates Immunity in Breast and Ovarian Cancer Patients. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Advanced clinical trials of dendritic cell vaccines in ovarian cancer. [2021]

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

Vaccine implications of folate binding protein, a novel cytotoxic T lymphocyte-recognized antigen system in epithelial cancers. [2020]