STEMVAC Vaccine for Breast Cancer

Overseen By Research Coordinator(s)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Washington

Must be taking: Endocrine therapy, CDK4/6 inhibitors, Capecitabine

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Cardiac conditions, Autoimmune diseases, others

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

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

Compensation: Varies

Number of Visits: 6

Duration: Up to 3 years

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine called STEMVAC, designed to help the body's immune system target and destroy specific proteins on breast cancer stem cells. It focuses on treating patients with hormone receptor-positive, HER2-negative breast cancer that has metastasized. The trial evaluates the vaccine's effectiveness when combined with standard hormone therapy or chemotherapy. Individuals living with metastatic breast cancer that is hormone receptor-positive and HER2-negative, and already receiving specific therapies, might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant advancements in breast cancer treatment.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but it does require that you are already receiving certain therapies like endocrine therapy with a CDK4/6 inhibitor or have completed at least one cycle of capecitabine. You cannot use immunosuppressive agents or systemic corticosteroids, and there must be 14 days between any non-study vaccine and the STEMVAC vaccine.

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

Research has shown that STEMVAC, a vaccine designed to help the immune system fight breast cancer, has been safe in earlier studies. One study found that patients tolerated the vaccine well, with no serious side effects directly linked to it. The most common mild side effects included soreness at the injection site and slight tiredness. This suggests that STEMVAC is generally safe for people.

It's also important to note that this trial is in the second phase of testing. This phase typically includes more participants than earlier ones and provides a better understanding of the treatment's safety. While this doesn't guarantee complete safety, it indicates that STEMVAC has already passed initial safety checks. Overall, these findings support the safety of STEMVAC for those considering joining this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Unlike the standard of care for breast cancer, which typically involves hormonal therapies like estrogen therapy (ET) and drugs that inhibit cell cycle proteins such as CDK4/6 inhibitors, or chemotherapy agents like capecitabine, STEMVAC takes a different approach. STEMVAC is a vaccine designed to stimulate the immune system to target and attack cancer stem cells, which are thought to play a key role in cancer recurrence and resistance to treatment. Researchers are excited about STEMVAC because it offers a potentially more targeted and durable treatment option by training the body's own defenses to recognize and destroy these cancer-driving cells. This novel mechanism could complement existing therapies and improve long-term outcomes for patients with breast cancer.

What evidence suggests that STEMVAC might be an effective treatment for metastatic breast cancer?

Research has shown that STEMVAC, a cancer vaccine, might help treat breast cancer by targeting specific proteins on cancer stem cells. After receiving booster doses, 90% of patients exhibited strong immune responses to these targets. This suggests that STEMVAC may help the immune system identify and attack cancer cells. In this trial, participants in Cohort 1 will receive STEMVAC alongside standard hormone therapy and CDK4/6 inhibitors, while those in Cohort 2 will receive STEMVAC with capecitabine chemotherapy. When combined with these standard treatments, STEMVAC could enhance their effectiveness. Early studies in other types of breast cancer have demonstrated similar promising results. ^{1 2 5 6 7}

Who Is on the Research Team?

Mary Disis, MD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for individuals with metastatic hormone receptor positive, HER2 negative breast cancer. Participants should not have previously received the STEMVAC vaccine and must be suitable for standard endocrine therapy or chemotherapy. Specific eligibility will depend on health status and prior treatments.

Inclusion Criteria

Specific hematologic and biochemical parameters within defined ranges

I am currently on a treatment plan that matches one of the study's groups.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I do not have any listed heart conditions.

Known hypersensitivity reaction to granulocyte-macrophage colony-stimulating factor (GM-CSF) adjuvant

Pregnancy or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive STEMVAC vaccine in combination with standard endocrine-based therapy or chemotherapy. Three 'priming' doses every 28 days, followed by two 'booster' doses at 6 and 9 months, and additional 'booster' doses every 6 months.

Up to 3 years

Multiple visits for vaccine administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and immunogenicity assessments.

Up to 3 years

Every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• STEMVAC

Trial Overview The trial tests a new vaccine called STEMVAC combined with either standard hormone therapy or chemotherapy (CDK4/6 inhibitors or capecitabine). The goal is to see if this combination can effectively target and destroy breast cancer stem cells by enhancing the immune response.

How Is the Trial Designed?

Group I: Cohort 2 (STEMVAC, capecitabine) Experimental Treatment 8 Interventions

After completion of 1 cycle of SOC capecitabine treatment, patients receive STEMVAC ID on the following schedule: 1) Three "priming" doses every 28 days; 2) Two "booster" doses at 6 and 9 months after "priming" dose #3; and 3) Additional "booster" doses every 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or ultrasound-guided biopsies, collection of blood samples, and FES PET scans throughout the trial.

Group II: Cohort 1 (STEMVAC, ET + CDK4/6i) Experimental Treatment 8 Interventions

After completion of 2 cycles of SOC ET + CDK4/6i therapy, patients receive STEMVAC ID on the following schedule: 1) Three "priming" doses every 28 days; 2) Two "booster" doses at 6 and 9 months after "priming" dose #3; and 3) Additional "booster" doses every 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or ultrasound-guided biopsies, as well as collection of blood samples throughout the trial.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07112053

Study Details | NCT07112053 | A Vaccine (STEMVAC) ... Giving STEMVAC in combination with standard ET or chemotherapy may be an effective treatment for metastatic HR positive, HER2 negative breast cancer.

2. trials.outcomes4me.com trials.outcomes4me.com/trial/NCT07078604/2061

A Cancer Vaccine (STEMVAC) in Combination With ... Giving STEMVAC in combination with chemotherapy may be an effective treatment for PD-L1 negative metastatic triple-negative breast cancer.

3. bcrf.org bcrf.org/blog/the-progress-and-future-of-breast-cancer-vaccines-with-dr-nora-disis/

The Progress and Future of Breast Cancer Vaccines with ... But after the two boosters, 90 percent of patients had very high levels of immunity, and they responded to almost all of the STEMVAC antigens.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9866612/

Cancer Vaccines for Triple-Negative Breast Cancer Cancer vaccines currently evaluated in TNBC for safety/efficacy, based on included results. Non-randomized trials are marked with asterisks ...

5. cancer.gov cancer.gov/clinicaltrials/NCI-2021-07734

STEMVAC in Patients with Early Stage Triple Negative ... STEMVAC is designed to target proteins that are expressed on breast cancer stem cells and it is believed to work by boosting the immune system to recognize and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07078604

NCT07078604 | A Cancer Vaccine (STEMVAC) in ... Giving STEMVAC in combination with chemotherapy may be an effective treatment for PD-L1 negative metastatic triple-negative breast cancer. Detailed Description.

7. jitc.bmj.com jitc.bmj.com/content/10/Suppl_2/A571

546 A phase I dose escalation study of STEMVAC, a multi- ... Primary endpoints were safety and immunogenicity. Secondary endpoints included persistence of the immune response after vaccination and ...