Efficacy and Safety Study of NeuVax™ (Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence



Status:Active, not recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2011
End Date:April 2025

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PRESENT: Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax™Treatment

Purpose of this trial:

1. To assess the efficacy and safety of NeuVax™ administered with adjuvant Leukine®
(sargramostim, GM-CSF).

2. To evaluate and compare the disease free survival (DFS) in the vaccinated and control
subjects.

This is a multicenter, multinational, prospective, randomized, double-blind, controlled
Phase 3 study.

The subjects eligible for this trial have an early stage node-positive breast cancer. Their
tumors express low or intermediate levels of the HER2 protein. NeuVax™ will be administered
after completion of front-line, standard of care therapy (surgery, radiation therapy, and
chemotherapy) and can be given concomitantly with physician prescribed endocrine treatment.

NeuVax™ is the immmunodominant nonapeptide derived from the extracellular domain of the HER2
protein, a well-established target for therapeutic intervention in breast carcinoma. The
nelipepimut sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTL) following
binding to HLA-A2/A3 molecules on antigen presenting cells (APC). These activated specific
CTLs recognize, neutralize and destroy through cell lysis HER2 expressing cancer cells,
including occult cancer cells and micrometastatic foci. The nelipepimut immune response can
also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope
spreading. Based on a successful Phase 2 trial, which achieved its primary endpoint of DFS,
the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA)
for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast
Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study.

The active portion of the study will last three years (36 months). The follow-up will last
from 5 to 10 years.

Endpoints:

1. Primary efficacy endpoint:

- 3-year DFS

2. Secondary efficacy endpoints:

- 5- and 10-year DFS

- 3-year OS

- 5- and 10-year OS

- Safety profile, and adverse events (AEs)

- Patterns of recurrence to include Time to recurrence (TTR), time to local
recurrence (TTLR), time to distant recurrence (TTDR), time to bone metastases
(TTBM)

Safety Assessments:

Subjects will be assessed at every study visit for the safety endpoints, AEs,vital signs,
physical examinations and laboratory data; yearly follow-up of survival will include imaging
studies, ECGs, MUGA or ECHO scans and concomitant medications.

Key Inclusion Criteria:

- Pathological diagnosis of invasive adenocarcinoma of the breast

- Breast cancer completely excised, or patient receiving neoadjuvant therapy prior to
surgery

- One of these 2 surgical treatments and axillary staging with sentinel lymph node
dissection or axillary dissection level I/II:

1. Total mastectomy-patients with a positive sentinel lymph node must have
undergone a completion axillary dissection level I/II

2. BCS (lumpectomy)-patients with a positive sentinel lymph node must have
undergone a completion axillary dissection level I/II unless they had clinically
node negative T1-T2 tumors and fewer than 3 involved lymph nodes

- Node-positive disease

- Primary tumor stage T1-3 at initial diagnosis

- HER2 negative (HER2 1+ by IHC or HER2 2+ by IHC/FISH)

- HLA-A2 or HLA-A3 haplotype

- Completed NCCN approved neo-adjuvant/adjuvant chemotherapy or both

- Completed radiation therapy

- No evidence of disease

- Able and willing (or have legal representative) to understand the study and provide
consent

Key Exclusion Criteria:

- Bilateral breast malignancy or suspicious mass in opposite breast

- Inflammatory breast malignancy

- History of prior breast cancer, ductal carcinoma in situ

- Prior trastuzumab therapy

- New York Heart Association Stage 3 or 4 cardiac disease

- Sensory/motor neuropathy ≥ Grade 2

- Autoimmune diseases or immune deficiency disease

- Subjects on chronic steroid therapy, other immunosuppressive therapy
We found this trial at
39
sites
100 N Humphreys Blvd
Memphis, Tennessee 38120
(901) 683-0055
The West Clinic, PC Hello and welcome to our office. Although it is our pleasure...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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Athens, Georgia 30607
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Baton Rouge, Louisiana 70809
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Bessemer, Alabama 35022
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Bronx, New York 10469
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Burlington, Massachusetts 01805
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Ft. Sam Houston, Texas 78234
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Jacksonville, Florida 32256
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Laguna Hills, California 92653
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Macon, Georgia 31201
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New York, New York 10021
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Orlando, Florida 32806
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3181 S.W. Sam Jackson Park Road
Portland, Oregon 97239
503 494-7999
OHSU Knight Cancer Institute OHSU Knight Cancer Institute is known worldwide for our contributions to...
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Royal Oak, Michigan 48071
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San Diego, California 92093
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Seattle, Washington 98104
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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