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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cancer vaccine designed to help the immune system target and destroy tumor cells in patients with advanced ovarian cancer. Researchers aim to determine if this vaccine is safe and effectively triggers the body's defenses against cancer. The treatment involves a series of injections following surgery and chemotherapy. This trial suits those with stage IIIC or IV ovarian cancer who have completed surgery and chemotherapy and currently show no signs of the disease. Participants must be able to travel to Mayo Clinic Rochester for follow-up visits. As an Early Phase 1 trial, participants will be among the first to receive this innovative treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that vaccines like the multi-epitope folate receptor alpha-loaded dendritic cell vaccine can help the immune system fight cancer. Studies have found that this type of vaccine usually causes mild side effects, such as soreness at the injection site or mild flu-like symptoms.

In studies with similar vaccines, patients generally tolerated the treatment well, with few serious side effects reported. This suggests that the vaccine is relatively safe for most people. However, as this is an early-stage trial, researchers are still closely monitoring the vaccine's safety. The treatment is still being tested to ensure its safety for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for ovarian cancer, which often include chemotherapy and surgery, the multi-epitope folate receptor alpha-loaded dendritic cell vaccine offers a unique approach. This vaccine targets the folate receptor alpha, a protein often overexpressed in ovarian cancer cells, by using dendritic cells to prompt the immune system to recognize and attack these cancerous cells. Researchers are excited about this treatment because it harnesses the body’s own immune system to fight cancer, potentially leading to more targeted and less toxic treatment compared to traditional options. Moreover, its phased administration, with an induction phase followed by a maintenance phase, aims to sustain a long-term immune response, which might improve outcomes for patients.

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

Research has shown that the Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine, which targets specific parts of cancer cells, may help treat ovarian cancer. In one study, five patients experienced a complete response, with their cancer becoming undetectable for about seven months on average. Another study found that the vaccine safely boosts the immune system, potentially leading to longer symptom-free periods. These findings suggest the vaccine helps the immune system locate and destroy cancer cells. Early results are promising, but further research is needed to confirm these effects. Participants in this trial will receive this vaccine therapy as part of the study. ^{1 2 6 7 8}

Who Is on the Research Team?

Matthew S. Block, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06639074

NCT06639074 | Folate Receptor Alpha Dendritic Cells ... This phase II trial compares the effect of folate receptor alpha dendritic cells (FRαDCs) to placebo in treating patients with stage III or IV ovarian, ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-03999

FRalphaDC Vaccine with Pembrolizumab for the Treatment ... This phase I/II trial tests the safety, side effects, best dose, and effectiveness of multi-epitope folate receptor alpha-loaded dendritic cell vaccine ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11154542/

Folate Receptor Alpha—A Novel Approach to Cancer Therapy This study found that five patients achieved complete response (CR), with a median response duration of 6.9 months (95% CI: 5.6–9.7) and an ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05920798?term=AREA%5BConditionSearch%5D(fallopian%20tube)%20AND%20AREA%5BBasicSearch%5D(dendritic%20vaccine)&rank=5

NCT05920798 | Vaccine Therapy Plus Pembrolizumab in ... This phase I/II trial tests the safety, side effects, best dose, and effectiveness of multi-epitope folate receptor alpha-loaded dendritic cell vaccine ...

5. nature.com nature.com/articles/s41467-020-18962-z

Th17-inducing autologous dendritic cell vaccination ... Thus, vaccination with Th17-inducing FRα-loaded DCs is safe, induces antigen-specific immunity, and is associated with prolonged remission.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7560895/

Th17-inducing autologous dendritic cell vaccination promotes ... Folate receptor alpha peptide vaccine generates immunity in breast and ovarian cancer patients. Clin. Cancer Res. 2018;24:3014–3025. doi ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02111941

Vaccine Therapy for Patients With Stage IIIC-IV Ovarian ... This pilot clinical trial studies the safety and immunogenicity of vaccine therapy in treating patients with stage IIIC-IV ovarian epithelial, ...

8. ctv.veeva.com ctv.veeva.com/study/vaccine-therapy-for-patients-with-stage-iiic-iv-ovarian-epithelial-fallopian-tube-or-primary-perit

Vaccine Therapy for Patients With Stage IIIC-IV Ovarian ... This pilot clinical trial studies the safety and immunogenicity of vaccine therapy in treating patients with stage IIIC-IV ovarian epithelial, fallopian tube, ...