Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-14

Study Completion Date

2023-05-17

Brief Summary

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This phase II trial studies how well nelipepimut-S plus GM-CSF vaccine therapy or sargramostim works in treating patients with breast cancer. Vaccines made from peptide or antigen and/or a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells that express breast cancer antigens. It is not yet known whether nelipepimut-S plus GM-CSF vaccine or sargramostim is more effective in treating patients with breast cancer.

Detailed Description

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PRIMARY OBJECTIVE:

I. Evaluate for nelipepimut-S-specific cytotoxic T lymphocyte (CTL; cluster of differentiation \[CD\]8+ T cell) response in patients receiving NeuVax (nelipepimut-S plus GM-CSF \[sargramostim\]) compared to patients receiving GM-CSF alone (control).

SECONDARY OBJECTIVES:

I. Toxicity profile and frequency of adverse events in women with ductal carcinoma in situ (DCIS) of the breast receiving nelipepimut-S vaccine as compared to women receiving GM-CSF alone.

II. Presence of DCIS at resection. III. Difference in HER2 expression in the biopsy and the surgical specimen excised post-vaccination.

IV. Histologic responses:

IVa. Degree of lymphocyte infiltration determined on hematoxylin and eosin (H\&E) stained slides and immune infiltration as determined by multiplex immunofluorescence staining for markers including but not limited to CD3, CD4 and CD8.

IVb. Immune infiltrates in normal tissue maximally distant from the tumor (in mastectomy samples).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive nelipepimut-S plus GM-CSF vaccine intradermally (ID) on days 0 and 14 and then undergo surgery on day 28.

ARM II: Patients receive sargramostim ID on days 0 and 14 and then undergo surgery on day 28.

After completion of study treatment, patients are followed up at 1 and 3 months.

Conditions

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Breast Ductal Carcinoma In Situ

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm I (nelipepimut-S plus GM-CSF vaccine)

Patients receive nelipepimut-S plus GM-CSF vaccine ID on days 0 and 14 and then undergo surgery on day 28.

Group Type EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Nelipepimut-S Plus GM-CSF Vaccine

Intervention Type DRUG

Given ID

Surgical Procedure

Intervention Type PROCEDURE

Undergo surgery

Arm II (sargramostim)

Patients receive sargramostim ID on days 0 and 14 and then undergo surgery on day 28.

Group Type ACTIVE_COMPARATOR

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Sargramostim

Intervention Type BIOLOGICAL

Given ID

Surgical Procedure

Intervention Type PROCEDURE

Undergo surgery

Interventions

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Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Nelipepimut-S Plus GM-CSF Vaccine

Given ID

Intervention Type DRUG

Sargramostim

Given ID

Intervention Type BIOLOGICAL

Surgical Procedure

Undergo surgery

Intervention Type PROCEDURE

Other Intervention Names

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E75 Plus GM-CSF E75 Vaccine Plus GM-CSF HLA A2/A3-Restricted HER-2/neu Peptide Vaccine Plus GM-CSF Nelipepimut-S Plus Sargramostim NeuVax Plus GM-CSF 23-L-Leucinecolony-Stimulating Factor 2 DRG-0012 Leukine Prokine rhu GM-CFS Sagramostim Sargramostatin Operation Surgery Surgery Type Surgery, NOS Surgical Surgical Intervention Surgical Interventions Surgical Procedures Type of Surgery

Eligibility Criteria

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Inclusion Criteria

* Participants must be pre- or post-menopausal
* Participants must have a diagnosis of DCIS made by core needle biopsy
* Participants must be human leukocyte antigen (HLA)-A2 positive
* Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1 (Karnofsky \>= 60%)
* Clinical chemistry less than 2 x normal upper limit of normal range
* Platelets \>= 100,000/mm\^3
* Hemoglobin \>= 10 g/dL
* Blood urea nitrogen \< 2 x upper limit of normal (ULN)
* Alkaline phosphatase \< 2 x ULN
* Lactate dehydrogenase \< 2 x ULN
* Creatinine \< 2 x ULN
* Bilirubin \< 2 x ULN
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) \< 2 x ULN
* A normal ejection fraction, as defined by the participant's institution; only limited echocardiograms (ECHOs) will be used as cardiac evaluation; no other tests are allowed; ECHO is to be done only in HLA-A2 positive participants; if ECHO has been done within 30 days prior to randomization and results showing a normal ejection fraction have been obtained prior to randomization, an additional ECHO is not needed at baseline
* Willingness to comply with all study interventions and follow-up procedures
* The ability to understand and willingness to sign a written informed consent document

Exclusion Criteria

* Invasive breast cancer; areas of microinvasion or suspicious for microinvasion on the core biopsy is allowed
* History of prior breast cancer treated within the past two years; patients completing all breast cancer-specific treatment over two years prior to the current diagnosis are eligible
* History of prior ductal carcinoma in situ (DCIS) treated within the past two years; patients completing all treatment for a previous diagnosis of DCIS over two years prior to the current diagnosis are eligible
* Prior lobular carcinoma in situ (LCIS) is allowed
* Pregnant, unwilling to use adequate contraception during study treatment duration or breastfeeding; the effects of NeuVax on the developing human fetus are unknown; for this reason and because NeuVax may be teratogenic, pregnant women will be excluded; all heterosexually active women who may become pregnant must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation OR be post-menopausal defined as any one of the following 1) prior hysterectomy, 2) absence of menstrual period for 1 year in the absence of prior chemotherapy or 3) absence of menstrual period for 2 years in women with a prior history of chemotherapy exposure who were pre-menopausal prior to chemotherapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
* Any autoimmune disease or other medical condition that, in the opinion of the investigator, would compromise the subject's safety
* Immune deficiency diseases such as immunoglobulin deficiency or immunosuppressive therapy that might interfere with appropriate immune response
* Known history of or known active infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C
* Patients on chronic steroid therapy or other immunosuppressive therapy except for topical or inhaled steroids known to have low systemic absorption
* Patients with a known hypersensitivity to GM-CSF, yeast-derived products, or any component of the GM-CSF product (e.g., mannitol)
* Concurrent treatment with other investigational agent
* History of non-breast malignancy within 5 years prior to randomization, except curatively treated superficial bladder cancer, carcinoma in situ of the cervix (stage 0-1), and basal cell or squamous cell carcinoma of the skin
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to NeuVax
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* No recent or planned immunotherapy

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Powel H Brown

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document