Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
Purpose
This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects.
Condition
- Breast Cancer
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Histologically confirmed diagnosis of HER2/neu positive primary breast cancer for all tumors biopsied at diagnosis (multifocal, multicentric, or synchronous contralateral disease) - Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast cancer therapy - Stage I, II, or III at presentation with pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes (residual disease) at surgery following completion of neoadjuvant therapy -OR- Stage III at presentation with pathologic complete response (pCR) at surgery following completion of neoadjuvant therapy - The subject can begin study therapy within one year of completion of adjuvant trastuzumab-based therapy and any other standard therapies, but, study therapy can be administered concurrently with endocrine therapy. - No clinical evidence of residual or persistent breast cancer per treating physician assessment - ECOG 0-2 - Adequate organ function - Negative pregnancy test or evidence of post-menopausal status - If of childbearing potential, willing to use a form of highly effective contraception - Subject must both reside in and have been treated for their cancer in the country in which the clinical site is located.
Exclusion Criteria
- Stage IV cancer or metastatic breast cancer at any time - Inflammatory breast cancer - Receiving other investigational agents - Receiving chemotherapy - Requiring long-term systemic treatment with corticosteroids or other immunosuppressive therapy - History of immunodeficiency or active autoimmune disease - A history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony-stimulating factors such as sargramostim, yeast-derived products, or any component of the investigational product - Other malignancies except adequately treated in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin - Active infection - Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment. Note: Subjects on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Subjects will be randomized to GLSI-100 or placebo. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm, which has closed to enrollment, will explore GLSI-100 immunotherapy in subjects without the HLA-A*02 allele.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Double-blind
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator 0.9% Normal Saline |
0.9% normal saline in subjects administered intradermally every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years) |
|
|
Experimental GLSI-100 |
GLSI-100 immunotherapy in subjects administered intradermally every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years) |
|
|
Experimental GLSI-100, Open-label |
Open-label arm: GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects administered intradermally every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years) |
|
Recruiting Locations
City of Hope - Cancer Center Phoenix
Goodyear, Arizona 85338
Goodyear, Arizona 85338
Tucson Medical Center HealthCare
Tucson, Arizona 85704
Tucson, Arizona 85704
City of Hope - Duarte Cancer Center
Duarte, California 91010
Duarte, California 91010
Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center
Fullerton, California 92835
Fullerton, California 92835
City of Hope - Orange County Lennar Foundation Cancer Center
Irvine, California 92618
Irvine, California 92618
University of California San Diego - Moores Cancer Center
La Jolla, California 92093
La Jolla, California 92093
Stanford Medicine Cancer Center - Stanford Women's Cancer Center
Palo Alto, California 74304
Palo Alto, California 74304
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94158
San Francisco, California 94158
University of California Los Angeles - Hematology / Oncology Parkside
Santa Monica, California 90404
Santa Monica, California 90404
PIH Health Hospital - Whittier Hospital
Whittier, California 90602
Whittier, California 90602
Rocky Mountain Cancer Centers
Denver, Colorado 80220
Denver, Colorado 80220
Yale Cancer Center - Smilow Cancer Hospital
New Haven, Connecticut 06511
New Haven, Connecticut 06511
Johns Hopkins Medicine - Kimmel Cancer Center-Sibley Memorial Hospital
Washington D.C., District of Columbia 20016
Washington D.C., District of Columbia 20016
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida 33146
Miami, Florida 33146
Northwestern University - Northwestern Memorial Hospital
Chicago, Illinois 60611
Chicago, Illinois 60611
Maryland Oncology Hematology
Annapolis, Maryland 21401
Annapolis, Maryland 21401
Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Contact:
MGH Cancer Center New Patient Access Team
877-394-5128
MGH Cancer Center New Patient Access Team
877-394-5128
Minnesota Oncology
Maple Grove, Minnesota 55369
Maple Grove, Minnesota 55369
Siteman Cancer Center - Washington University Medical Campus
St Louis, Missouri 63110
St Louis, Missouri 63110
Nebraska Cancer Specialists
Omaha, Nebraska 68114
Omaha, Nebraska 68114
Nebraska Medicine - University of Nebraska Medical Center
Omaha, Nebraska 68198
Omaha, Nebraska 68198
Comprehensive Cancer Centers of Nevada
Henderson, Nevada 89052
Henderson, Nevada 89052
New York Oncology Hematology
Albany, New York 12065
Albany, New York 12065
New York-Presbyterian - Columbia University Irving Medical Center
New York, New York 10032
New York, New York 10032
Stony Brook University Cancer Center
Stony Brook, New York 11794
Stony Brook, New York 11794
Compass Oncology - Northwest Cancer Specialists
Tigard, Oregon 97223
Tigard, Oregon 97223
Redeemer Health - Holy Redeemer Hospital
Meadowbrook, Pennsylvania 19046
Meadowbrook, Pennsylvania 19046
Sidney Kimmel Comprehensive Cancer Center - Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas 75231
Dallas, Texas 75231
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas 75246
Dallas, Texas 75246
The University of Texas Southwestern Medical Center
Dallas, Texas 75390
Dallas, Texas 75390
Baylor College of Medicine - Dan L. Duncan Comprehensive Cancer Center
Houston, Texas 77057
Houston, Texas 77057
The University of Texas Health Sciences Center at San Antonio - Mays Cancer Center
San Antonio, Texas 78229
San Antonio, Texas 78229
Texas Oncology - San Antonio Medical Center
San Antonio, Texas 78240
San Antonio, Texas 78240
Texas Oncology - Gulf Coast
Sugar Land, Texas 77479
Sugar Land, Texas 77479
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
Virginia Cancer Specialists
Fairfax, Virginia 22031
Fairfax, Virginia 22031
More Details
- Status
- Recruiting
- Sponsor
- Greenwich LifeSciences, Inc.