| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00581 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| UW14090 | |||
| N01-CN-2012-00033 | |||
| UWI4090 | Other Identifier | University of Wisconsin Hospital and Clinics | |
| UWI2014-03-01 | Other Identifier | DCP | |
| N01CN00033 | U.S. NIH Grant/Contract | View source | |
| P30CA014520 | U.S. NIH Grant/Contract | View source | |
| RG1716053 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| University of Wisconsin, Madison | OTHER |
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This phase I trial studies the side effects and best dose of a vaccine therapy in preventing cancer from coming back in patients with non-metastatic, node positive, human epidermal growth factor receptor (HER)2 negative breast cancer in which all signs and symptoms have disappeared. Vaccines made from deoxyribonucleic acid (DNA) may help the body build an effective immune response to kill tumor cells. Giving multiple vaccinations may make a stronger immune response and prevent or delay the return of cancer.
OUTLINE: This is a dose escalation study of WOKVAC.
Patients receive WOKVAC with sargramostim intradermally (ID) on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with axillary lymph node dissection (ALND) will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
After completion of study treatment, patients are followed up at 1 month, 6 months and annually for up to 5 years thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (WOKVAC with sargramostim) | Experimental | Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0 | Toxicities by grade that were related (possibly, probably or definitely) to the study vaccine noted during the immunization regimen will be summarized. This is done by arm, Grade and Attribution to study vaccine. | Up to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of IgG Antibodies | Immune response will be measured by indirect enzyme-linked immunosorbent assay and serum antibody avidity to determine an avidity index before and after vaccination. Patients will be considered to have developed an antibody response if antigen specific IgG antibodies are both detectable and have moderate to high avidity. | Up to 4 months |
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Inclusion Criteria:
Patients with non-metastatic, node positive, HER2 negative breast cancer, confirmed by pathology report, who are in remission and defined as having no evidence of disease (NED); HER2 negative is defined as
Patients must be at least 28 days post cytotoxic chemotherapy, radiotherapy, monoclonal antibody and/or other biologic therapy, prior to enrollment; patients on bisphosphonates, denosumab, and/or endocrine therapy administered during the study are eligible and may continue throughout duration of study
Patients must be at least 28 days post systemic steroids prior to enrollment
Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =< 2
White blood cell (WBC) >= 3000/mm^3
Hemoglobin (Hgb) >= 10 g/dl
Lymphocyte count >= 800/mm^3
Platelet count >= 75,000/mm^3
Serum creatinine =< 2.0 mg/dl or creatinine clearance > 60 ml/min
Total bilirubin =< 1.5 mg/dl
Aspartate aminotransferase (AST)/Serum glutamic oxaloacetic transaminase (SGOT) =< 2 times upper limit of normal (ULN)
Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
The effects of WOKVAC on the developing human fetus are unknown. For this reason, patients who are having sex that can lead to pregnancy must agree to use adequate contraception (hormonal, barrier method of birth control, or abstinence) for the duration of study participation; should a woman become pregnant while participating in the study, she should inform her study doctor immediately and will not receive any more study treatment
Left ventricular ejection fraction (LVEF) results must be >= lower limit of normal (LLN) for institution performing based on results from the multi-gated acquisition (MUGA) or echocardiogram (ECHO) done at baseline
Willing to not undergo any elective surgical procedure with general anesthesia or conscious sedation through the 1 month post-vaccination visit
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
Patients with any of the following cardiac conditions:
Patients may not be receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to WOKVAC
Patients with any contraindication or known hypersensitivity to receiving sargramostim (recombinant human granulocyte macrophage colony stimulating factor [rhuGM-CSF]) or other yeast based products
Pregnant women are excluded from this study because WOKVAC is a vaccine agent with unknown potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with WOKVAC breastfeeding should be discontinued if the mother is treated with this vaccine
History of diabetes
Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
History of autoimmunity that has not been controlled with treatment in the last 12 months
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| Name | Affiliation | Role |
|---|---|---|
| Kari Wisinski | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States | ||
| University of Wisconsin Hospital and Clinics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24154719 | Result | Disis ML, Gad E, Herendeen DR, Lai VP, Park KH, Cecil DL, O'Meara MM, Treuting PM, Lubet RA. A multiantigen vaccine targeting neu, IGFBP-2, and IGF-IR prevents tumor progression in mice with preinvasive breast disease. Cancer Prev Res (Phila). 2013 Dec;6(12):1273-82. doi: 10.1158/1940-6207.CAPR-13-0182. Epub 2013 Oct 23. | |
| 42082270 | Derived | Stanton SE, Cecil DL, Bailey HH, Liu Y, Gwin WR, Colveler AL, Liao JB, Wisinski KB, Barroilhet L, Kim K, Havighurst TC, DeShong K, Twaroski K, Childs JS, Dimond E, Wojtowicz M, Heckman-Stoddard BM, Disis ML. Safety and immunogenicity of a tri-antigen vaccine targeting IGFBP-2, HER2, and IGF-IR in participants with non-metastatic breast cancer. J Immunother Cancer. 2026 May 4;14(5):e014314. doi: 10.1136/jitc-2025-014314. |
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The original intent of this study did not define a plan to make IPD available. We will follow the NCI policy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (WOKVAC With Sargramostim) - Dose 150 mcg + 100 mcg Sargramostim | Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2020 |
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| pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine |
| Biological |
Given ID |
|
|
| Sargramostim | Biological | Given ID |
|
|
| Assessment of T Helper Th1:Th2 Ratio | IFN-g (Th1) and IL-10 (Th2) T-cells will be evaluated using enzyme-linked immunosorbent spot assay. Patients will be considered to have developed a Th1 immune response as the sum IFN-Ɣ magnitude from all antigens to maximum response. This will be presented as a median fold change from baseline to the maximum response (1 or 6 months after vaccination). | Up to 9 months |
| Assessment of the Immunogenicity of WOKVAC by Generation of IGFBP-2, HER2, and IGF-1R Specific Type 1 (Th1) T- Cells | Immune responses will be measured by IFN-g enzyme-linked immunosorbent spot assay using blood (PBMC) represented by a maximum immune response generated to each antigen individually measured as corrected spots per well (cSPW). At the immune evaluations, each patient was given a value to indicate their immune response at both baseline and post vaccination. This data is represented by a median response, at both baseline (before vaccination) and 1 month or 6 months after the last vaccination of 3 vaccines (maximum response), to each of the 3 vaccine antigens HER2, IGFBP-2 or IGF1R. | Up to 24 weeks |
| Level of Antigen Specific Central and Effector Memory Phenotypes (Persistent Memory T Cell Response) | Assessed by flow cytometry of peripheral blood mononuclear cells using an established T-cell activation panel and summarized with mean and standard deviation or median and range over time. | Up to 6 months after the last vaccine |
| Modulation of Myeloid Derived Suppressor Cell Levels | Assessed by flow cytometry of peripheral blood mononuclear cells using an established myeloid derived suppressor cell/ regulatory T-cell panel and summarized with mean and standard deviation or median and range over time. | Up to 24 weeks |
| Modulation of T Regulatory Cell Levels | Assessed by flow cytometry of peripheral blood mononuclear cells using an established myeloid derived suppressor cell/ regulatory T-cell panel and summarized with median and range. FOXP3 is used to identify regulatory T cells, specifically CD4+ cells isolated from PBMC. | Up to 24 weeks |
| Madison |
| Wisconsin |
| 53792 |
| United States |
| FG001 | Treatment (WOKVAC With Sargramostim) - Dose 300 mcg + 100 mcg Sargramostim | Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration. |
| FG002 | Treatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim | Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration. |
| COMPLETED |
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| NOT COMPLETED |
|
This study allowed for replacement of patients that did not complete the 3 WOKVAC vaccines + the 1 month post vaccine 3 visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (WOKVAC With Sargramostim) - Dose 150 mcg + 100 mcg Sargramostim | Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration. Laboratory Biomarker Analysis: Correlative studies pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine: Given ID Sargramostim: Given ID |
| BG001 | Treatment (WOKVAC With Sargramostim) - Dose 300 mcg + 100 mcg Sargramostim | Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration. Laboratory Biomarker Analysis: Correlative studies pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine: Given ID Sargramostim: Given ID |
| BG002 | Reatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim | Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration. Laboratory Biomarker Analysis: Correlative studies pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine: Given ID Sargramostim: Given ID |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0 | Toxicities by grade that were related (possibly, probably or definitely) to the study vaccine noted during the immunization regimen will be summarized. This is done by arm, Grade and Attribution to study vaccine. | Posted | Number | Count of Related Adverse Events per Arm | Up to 9 months | Count of Related Adverse Events per Arm | Count of Related Adverse Events per Arm |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Assessment of IgG Antibodies | Immune response will be measured by indirect enzyme-linked immunosorbent assay and serum antibody avidity to determine an avidity index before and after vaccination. Patients will be considered to have developed an antibody response if antigen specific IgG antibodies are both detectable and have moderate to high avidity. | Not Posted | Up to 4 months | Participants | |||||||||||||||||||||||||||||||||||||||||
| Secondary | Assessment of T Helper Th1:Th2 Ratio | IFN-g (Th1) and IL-10 (Th2) T-cells will be evaluated using enzyme-linked immunosorbent spot assay. Patients will be considered to have developed a Th1 immune response as the sum IFN-Ɣ magnitude from all antigens to maximum response. This will be presented as a median fold change from baseline to the maximum response (1 or 6 months after vaccination). | Posted | Median | Full Range | score on a scale | Up to 9 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Assessment of the Immunogenicity of WOKVAC by Generation of IGFBP-2, HER2, and IGF-1R Specific Type 1 (Th1) T- Cells | Immune responses will be measured by IFN-g enzyme-linked immunosorbent spot assay using blood (PBMC) represented by a maximum immune response generated to each antigen individually measured as corrected spots per well (cSPW). At the immune evaluations, each patient was given a value to indicate their immune response at both baseline and post vaccination. This data is represented by a median response, at both baseline (before vaccination) and 1 month or 6 months after the last vaccination of 3 vaccines (maximum response), to each of the 3 vaccine antigens HER2, IGFBP-2 or IGF1R. | Posted | Median | Full Range | correct spots per well (cSPW)/10^6 PBMC | Up to 24 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Level of Antigen Specific Central and Effector Memory Phenotypes (Persistent Memory T Cell Response) | Assessed by flow cytometry of peripheral blood mononuclear cells using an established T-cell activation panel and summarized with mean and standard deviation or median and range over time. | Not Posted | Up to 6 months after the last vaccine | Participants | |||||||||||||||||||||||||||||||||||||||||
| Secondary | Modulation of Myeloid Derived Suppressor Cell Levels | Assessed by flow cytometry of peripheral blood mononuclear cells using an established myeloid derived suppressor cell/ regulatory T-cell panel and summarized with mean and standard deviation or median and range over time. | Posted | Median | Full Range | percentage of m-MDSC | Up to 24 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Modulation of T Regulatory Cell Levels | Assessed by flow cytometry of peripheral blood mononuclear cells using an established myeloid derived suppressor cell/ regulatory T-cell panel and summarized with median and range. FOXP3 is used to identify regulatory T cells, specifically CD4+ cells isolated from PBMC. | Posted | Median | Full Range | % of Foxp3+ cells among CD4+ cells | Up to 24 weeks |
|
Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (WOKVAC With Sargramostim) - Dose 150 mcg + 100 mcg Sargramostim | Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration. | 0 | 10 | 0 | 10 | 10 | 10 |
| EG001 | Treatment (WOKVAC With Sargramostim) - Dose 300 mcg + 100 mcg Sargramostim | Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration. | 1 | 12 | 0 | 12 | 12 | 12 |
| EG002 | Treatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim | Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration. | 1 | 10 | 0 | 10 | 10 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 1 - 1/2 was deemed possibly related to study treatment Arm 3 - 1/1 was deemed probably related to study treatment |
|
| Alanine aminotransferase increased | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Arm 1 - 1/1 was deemed possibly related to study treatment Arm 2 - 2/2 deemed possibly related to study treatment |
|
| Akathisia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 3 - 1/2 was possibly related to the study treatment as it increased in grade (in the same patient) |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment | Allergic reaction was unrelated to the study vaccine |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 1 - 1/2 events was deemed possibly related as it changed in grade |
|
| Breast pain | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chest pain | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment | Chest pain was unrelated to study vaccine |
|
| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 1 - 3/5 events were deemed related to the study treatment Arm 2 - 5/8 events were deemed related to the study treatment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 1 - 3/5 events were deemed possibly related to study treatment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 2 - 1/5 events was deemed possibly related to study treatment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 3 - 1/3 events was deemed possibly related to treatment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 2 - 1/1 events was deemed possibly related to study treatment Arm 3 - 1/2 events was deemed possibly related to study treatment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 2 - 1/3 events was deemed probably related to study treatment Arm 3 - 1/2 events was deemed possibly related to study treatment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Erythema multiforme is unrelated to the study vaccine |
|
| Edema face | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment | Arm 3 - 1/1 events was deemed possibly related to study treatment |
|
| Eye Disorder - Other | Eye disorders | CTCAE (4.0) | Non-systematic Assessment | Eye disorder was unrelated to study vaccine |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 1 - 6/8 events were deemed related to study treatment Arm 2 - 4/4 events were deemed related to study treatment Arm 3 - 1/1 events was deemed possibly related to study treatment |
|
| Flu like symptoms | General disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 1 - 6/6 events were deemed related to study treatment Arm 2 - 10/11 events were deemed related to study treatment Arm 3 - 2/2 events were deemed related to study treatment |
|
| Flushing | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 1 - 4/4 events were deemed possibly related to study treatment Arm 2 - 1/2 events was deemed possibly related to study treatment |
|
| Gallbladder pain | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 1 - 1/5 events was deemed possibly related to study treatment Arm 2 - 4/10 events was deemed possibly related to study treatment Arm 3 - 1/3 events was deemed possibly related to study treatment |
|
| Hot flashes | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Glucose | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Arm 2: 2/4 glucose results were deemed possibly related to the study vaccine |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment | Note: Hypertension was defined as a reported abnormal blood pressure per protocol |
|
| Hyperthyroidism | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 3 - 1/1 events was deemed possibly related to study treatment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 1 - 1/5 events was deemed possibly related to the study treatment Arm 2 - 1/2 events was deemed possibly related to the study treatment Arm 3 - 1/3 events was deemed possibly related to the study treatment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 1 - 1/1 events is deemed possibly related to study treatment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Arm 2 - 2/3 events was deemed possibly related to study treatment Arm 3 - 1/3 events was deemed possibly related to study treatment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Arm 1 - 1/1 adverse event was deemed possibly related to study vaccination |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Infections and Infestations - Other | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 1 - 12/14 events were deemed related to the study treatment Arm 2 - 14/17 events were deemed related to the study treatment Arm 3 - 12/13 events were deemed related to the study treatment |
|
| Investigations - Other | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Complement 3 | Investigations | CTCAE (4.0) | Systematic Assessment | Arm 2 - 1/2 events was deemed possibly related to study treatment |
|
| Lymphedema | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 1 - 1/1 events was deemed probably related to the study treatment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Arm 1 - 2/7 events was deemed possibly related to study treatment Arm 2 - 2/4 events was deemed possibly related to study treatment Arm 3 - 2/5 events was deemed possibly related to study treatment |
|
| GAD65 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| ANA | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Malaise | General disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 2 - 2/2 events were deemed probably related to study treatment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 1 - 3/7 events was deemed possibly related to study treatment Arm 2 - 3/7 events was deemed possibly related to study treatment |
|
| Musculoskeletal and connective tissue disorder - other | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 1 - 4/11 events was deemed possibly related to study treatment Arm 2 - 1/3 events was deemed possibly related to study treatment Arm 3 - 1/3 events was deemed possibly related to study treatment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Arm 1 - 1/1 events was deemed possibly related to study treatment Arm 2 - 1/1 events was deemed possibly related to study treatment Arm 3 - 1/1 events was deemed possibly related to study treatment |
|
| Neoplasms benign, malignant and unspecified - Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 1 - 1/5 events was deemed possibly related to study treatment Arm 2 - 1/1 events was deemed possibly related to study treatment Arm 3 - 1/3 events was deemed possibly related to study treatment |
|
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Oral dysesthesia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 1 - 1/1 events was deemed possibly related to study |
|
| Phantom pain | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment | ARM 2: 1/2 palpitations was deemed possibly related to study vaccine and was a Grade 1 |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment | Arm 3 - 1/2 events was deemed possibly related to study treatment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 1 - 1/5 events was deemed possibly related to study treatment Arm 2 - 1/6 events was deemed possibly related to study treatment Arm 3 - 1/2 events was deemed possibly related to study treatment |
|
| Presyncope | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 3 - 2/2 events was deemed possibly related to study treatment |
|
| Renal calculi | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 2 - 2/3 events was deemed possibly related to study treatment Arm 3 - 1/2 events was deemed possibly related to study treatment |
|
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Surgical and medical procedures - Other | Surgical and medical procedures | CTCAE (4.0) | Non-systematic Assessment | ARM 1: 1 patient: replacement of breast implants 1 patient: revision of DIEP flap reconstruction and delayed recovery from anesthesia |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract infection (UTI) | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Arm 1 - 1/2 events was deemed possibly related to study treatment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment | Arm 1 - 1/5 events was deemed possibly related to study treatment Arm 2 - 2/7 events was deemed possibly related to study treatment Arm 3 - 3/4 events was deemed possibly related to study treatment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer S. Childs | University of Washington Medical Center | 2066162305 | childj@u.washington.edu |
| May 10, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C081222 | sargramostim |
| D003115 | Colony-Stimulating Factors |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
| White - Hispanic or Latino |
|
| White - Not Reported |
|
| Asian - Unknown |
|
| Unknown - Unknown |
|
| Canada |
|
|
| OG002 | Treatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim | Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration. |
|
|
| OG002 | Treatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim | Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration. |
|
|
| OG002 | Treatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim | Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration. |
|
|
| OG002 | Treatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim | Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration. |
|
|