FLAMINGO-01: Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
Study Details
Study Description
Brief Summary
This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A02 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-A02 positive and HER2/neu positive subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: 0.9% Normal Saline 0.9% normal saline in HLA-A*02 positive and HER2/neu positive subjects 0.9% normal saline intradermally every month for first 6 months then every 6 months for next 2.5 years (11 intradermal doses over 3 years) |
Biological: Placebo
0.9% Normal Saline
|
| Experimental: GLSI-100 GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects GLSI-100 intradermally (GP2 and GM-CSF syringes), every month for first 6 months then every 6 months for next 2.5 years (11 intradermal doses over 3 years) |
Biological: GLSI-100
500 mcg/mL GP2 and 125 mcg/mL GM-CSF
|
| Experimental: GLSI-100, Open-label Open-label arm: GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects GLSI-100 intradermally (GP2 and GM-CSF syringes), every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years) |
Biological: GLSI-100
500 mcg/mL GP2 and 125 mcg/mL GM-CSF
|
Outcome Measures
Primary Outcome Measures
- Invasive Breast Cancer-free Survival (IBCFS) [Median 4 years of follow-up (interim analysis planned)]
IBCFS is defined as the time from the first dose of study medication until the date of ipsilateral invasive breast cancer recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or any cause mortality.
Secondary Outcome Measures
- Invasive Disease-free Survival (IDFS) [Median 4 years of follow-up (interim analysis planned)]
IDFS is defined as the time from the first dose of study medication until the date of ipsilateral invasive breast cancer recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, or any cause mortality.
- Distant Disease-free Survival (DDFS) [Median 4 years of follow-up (interim analysis planned)]
DDFS will be defined as the time from the first dose of study medication to the time of distant disease recurrence or death.
- Overall Survival [Median 4 years of follow-up (interim analysis planned)]
Overall survival will be defined as the time from the first dose of study medication until death from any cause.
- Quality of Life Questionnaire Core 30 (QLQ-C30) [Baseline and 36 months]
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
- Quality of Life FACT-GP5 [Baseline and 36 months]
FACT-GP5 to assess global side effect impact
Other Outcome Measures
- Immune Response Measurements [Screening, Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12, Month 13, Month 18, Month 19, Month 24, Month 25, Month 30, Month 31, Month 36, Month 37, Month 42, Month 48]
Immune response will be measured by Delayed-Type Hypersensitivity (DTH) tests and immunologic assays.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
HLA-A02-positive, unless being enrolled in the third non-HLA-A02 arm
-
Histologically confirmed diagnosis of HER2/neu positive primary breast cancer
-
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 90 days 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
Exclusion Criteria:
-
Stage IV cancer or metastatic breast cancer at any time
-
Inflammatory breast cancer
-
Receiving other investigational agents
-
Receiving chemotherapy
-
Requiring 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
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Southern California | Los Angeles | California | United States | 90033 |
| 2 | University of California, Los Angeles | Los Angeles | California | United States | 90404 |
| 3 | Maryland Oncology Hematology (USOR) | Annapolis | Maryland | United States | 21401 |
| 4 | Nebraska Cancer Specialists (USOR) | Omaha | Nebraska | United States | 68114 |
| 5 | Columbia University | New York | New York | United States | 10032 |
| 6 | Compass Oncology (USOR) | Tigard | Oregon | United States | 97223 |
| 7 | Texas Oncology - Dallas (USOR) | Dallas | Texas | United States | 75246 |
| 8 | Baylor College of Medicine | Houston | Texas | United States | 77057 |
| 9 | Texas Oncology San Antonio (USOR) | San Antonio | Texas | United States | 78240 |
| 10 | Texas Oncology - Tyler (USOR) | Tyler | Texas | United States | 75702 |
Sponsors and Collaborators
- Greenwich LifeSciences, Inc.
Investigators
- Principal Investigator: Mothaffar F Rimawi, MD, Baylor College of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GLSI-21-01