STEMVAC in Patients With Early Stage Triple Negative Breast Cancer

NCT05455658 | Active Not Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: RG1122380NCI-2021-07734UG1CA242635UWI20-00-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief Summary

This phase II trial studies the effect of DNA plasmid based vaccine (STEMVAC) in treating patients with patients with stage IB-III triple negative breast cancer. STEMVAC may wake up the immune system in patients who have had a diagnosis of triple negative breast cancer and have been treated. STEMVAC targets proteins that are expressed on breast cancer cells and works by boosting the immune system to recognize and destroy the invader cancer cell proteins that are causing the disease. The purpose of this trial is to test the immune system's response to STEMVAC.

Conditions

Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Triple-Negative Breast Carcinoma

Outcome Measures

Primary Outcomes (6)

• Cellular immune response: incidence

  Defined by the incidence of development of the Th1 (IFN-gamma \[g\]) antigen specific immune response against STEMVAC antigens using enzyme-linked immunosorbent spot assay (ELISPOT).

  At 1 month after 3rd vaccination

• Cellular immune response: incidence

  Defined by the incidence of development of the Th1 (IFN-gamma \[g\]) antigen specific immune response against STEMVAC antigens using enzyme-linked immunosorbent spot assay (ELISPOT).

  At 10 months after 3rd vaccination

• Cellular immune response: magnitude

  Defined by the magnitude of development of the Th1 (IFN-gamma \[g\]) antigen specific immune response against STEMVAC antigens using enzyme-linked immunosorbent spot assay (ELISPOT). The magnitude of immune response is defined as the sum of the corrected spots/well values calculated at each time point.

  At 1 month after 3rd vaccination

• Cellular immune response: magnitude

  Defined by the magnitude of development of the Th1 (IFN-gamma \[g\]) antigen specific immune response against STEMVAC antigens using enzyme-linked immunosorbent spot assay (ELISPOT). The magnitude of immune response is defined as the sum of the corrected spots/well values calculated at each time point.

  At 3 months after 3rd vaccination

• Cellular immune response: magnitude

  Defined by the magnitude of development of the Th1 (IFN-gamma \[g\]) antigen specific immune response against STEMVAC antigens using enzyme-linked immunosorbent spot assay (ELISPOT). The magnitude of immune response is defined as the sum of the corrected spots/well values calculated at each time point.

  At 9 months after 3rd vaccination

• Cellular immune response: magnitude

  Defined by the magnitude of development of the Th1 (IFN-gamma \[g\]) antigen specific immune response against STEMVAC antigens using enzyme-linked immunosorbent spot assay (ELISPOT). The magnitude of immune response is defined as the sum of the corrected spots/well values calculated at each time point.

  At 10 months after 3rd vaccination

Secondary Outcomes (4)

• Kinetics of the magnitude of antigen specific IFN-gamma ELISPOT counts

  13 months

• Incidence of adverse events

  1 month after last booster vaccine

• Activation status and repertoire diversity of peripheral blood T-cells

  Prior to and after STEMVAC vaccination

• Relapse free survival (RFS)

  Up to 5 years

Study Arms (1)

Prevention (STEMVAC vaccine, sargramostim)

EXPERIMENTAL

Patients receive STEMVAC vaccine with sargramostim ID every month for 3 months in the absence of disease progression or unacceptable toxicity. Patients then receive STEMVAC vaccine with sargramostim ID booster injections 3 months after the 3rd vaccination and 6 months after the 1st booster vaccination.

Biological: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine; Biological: Sargramostim

Interventions

Sargramostim BIOLOGICAL

Given ID

Also known as: 123774-72-1, 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine, rhu GM-CFS, Sagramostim, Sargramostatin

Prevention (STEMVAC vaccine, sargramostim)

CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine BIOLOGICAL

Given IV

Also known as: CD105/Yb-1/SOX2/CDH3/MDM2 Plasmid Vaccine, STEMVAC, STEMVAC Th1 Polyepitope Plasmid-based Vaccine

Prevention (STEMVAC vaccine, sargramostim)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with triple negative breast cancer, stages IB, II or III. Estrogen receptor (ER)-negative and progesterone receptor (PR)-negative is defined as breast cancer with less than 10% of ER or PR expression. HER2 negative is defined as:
• + HER2 expression by immunohistochemistry (IHC) OR
• Fluorescence in situ hybridization (FISH) negative OR
• HER2 2+ and FISH negative
• Note: Participants with low ER positivity (≤10%) who are already on adjuvant hormonal therapy will be allowed on study and can continue their adjuvant hormonal treatment during study participation.
• Participants must have completed all standard of care (or investigational) systemic therapy (including immune modulating agents) and radiotherapy if used between 28 and 365 days prior to enrollment
• Participants must agree to avoid systemic steroids for the duration of the treatment period and until completion of the 1 month post 2nd booster vaccine visit (end of treatment)
• Participants must be at least 18 years of age
• \* Note: Because no dosing or adverse event (AE) data are currently available on the use of STEMVAC in participants \< 18 years of age, children and adolescents are excluded from this study but will be eligible for future pediatric trials, if applicable.
• Participants must have Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1
• White blood cell (WBC) \>= 3000/mm\^3 (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment)
• Lymphocyte count \>= 800/mm\^3 (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment)
• Platelet count \>= 100,000/mm\^3 (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment)
• Hemoglobin (Hgb) \>= 10 g/dl (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment)
• Serum creatinine =\< 1.2 mg/dl OR creatinine clearance \> 60 ml/min (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment)

You may not qualify if:

• Contraindication or known hypersensitivity to receiving sargramostim (rhuGM-CSF) or other products
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to STEMVAC
• Participants receiving any other investigational agents
• Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) is prohibited during the treatment period of the study, except when taken as low-dose (81 mg) aspirin therapy. Prohibited chronic use is defined as daily use for more than 7 days
• Participants with any clinically significant autoimmune disease uncontrolled with treatment
• Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant and breastfeeding women are excluded from this study
• Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
• \* Note: These individuals are excluded in order to avoid confounding an existing condition with an immune response to STEMVAC
• Chronic usage of immunosuppressants and glucocorticoids (methotrexate for RA, etc.)
• History of invasive breast cancer prior to TNBC diagnosis \* Note: Prior DCIS is allowable

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (3)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

sargramostim; Colony-Stimulating Factors

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Mary Disis, MD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

• Howard Bailey, MD

  University of Wisconsin, Madison

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 13, 2022
• Study Start: November 17, 2022
• Primary Completion (Estimated): July 16, 2026
• Study Completion (Estimated): July 16, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)