NCT05232916
Recruiting
Phase 3
A Randomized, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects With Residual Disease or High-Risk PCR After Both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01)
Overview
- Phase
- Phase 3
- Intervention
- GLSI-100
- Conditions
- Breast Cancer
- Sponsor
- Greenwich LifeSciences, Inc.
- Enrollment
- 598
- Locations
- 160
- Primary Endpoint
- Invasive Breast Cancer-free Survival (IBCFS)
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •HLA-A\*02-positive, unless being enrolled in the third non-HLA-A\*02 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 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
- •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 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.
Arms & Interventions
GLSI-100
GLSI-100 immunotherapy in 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)
Intervention: GLSI-100
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)
Intervention: GLSI-100
0.9% Normal Saline
0.9% normal saline in 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)
Intervention: Placebo
Outcomes
Primary Outcomes
Invasive Breast Cancer-free Survival (IBCFS)
Time Frame: 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 Outcomes
- Invasive Disease-free Survival (IDFS)(Median 4 years of follow-up (interim analysis planned))
- Distant Disease-free Survival (DDFS)(Median 4 years of follow-up (interim analysis planned))
- Overall Survival(Median 4 years of follow-up (interim analysis planned))
- Quality of Life Questionnaire Core 30 (QLQ-C30)(Baseline and 36 months)
- Quality of Life FACT-GP5(Baseline and 36 months)
Study Sites (160)
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Related News
Greenwich LifeSciences Expands FLAMINGO-01 Breast Cancer Trial to Ireland, Adding to Global Network of 150 Sites- Greenwich LifeSciences received European regulatory approval to expand its Phase III FLAMINGO-01 clinical trial to Ireland, adding to a global network of 150 trial sites across seven countries.
- The trial evaluates GLSI-100 immunotherapy in HER2-positive breast cancer patients with residual disease or high-risk pathologic complete response after surgery and trastuzumab treatment.
- Ireland diagnosed 3,723 new breast cancer cases in 2022, representing 30% of all cancers in women and the second leading cause of cancer death with 883 deaths.
- Dr. Janice Walshe from St Vincent's University Hospital in Dublin will serve as national principal investigator, bringing extensive experience in international breast cancer trials.Greenwich LifeSciences' GLSI-100 Receives FDA Fast Track Designation for HER2-Positive Breast Cancer Prevention- Greenwich LifeSciences announced that the FDA has granted Fast Track designation for GLSI-100, an immunotherapy designed to prevent breast cancer recurrences in HLA-A*02 patients with HER2-positive breast cancer.
- The designation enables more frequent FDA communication and potential rolling review of the Biologic License Application, potentially accelerating approval timelines for the investigational treatment.
- Previous Phase IIb data demonstrated an 80% or greater reduction in metastatic breast cancer recurrence rates over 5 years compared to placebo in HER2/neu 3+ patients.
- The company is currently conducting FLAMINGO-01, a Phase III trial designed to evaluate GLSI-100's safety and efficacy in approximately 750 patients across up to 150 global sites.Greenwich LifeSciences Advances Phase III FLAMINGO-01 Trial for HER2-Positive Breast Cancer Immunotherapy- Greenwich LifeSciences is conducting FLAMINGO-01, a Phase III trial evaluating GLSI-100 immunotherapy to prevent breast cancer recurrences in HER2-positive patients with residual disease.
- The global trial, led by Baylor College of Medicine, plans to enroll up to 750 patients across 150 sites and is designed to detect a 70% reduction in recurrence risk.
- GLSI-100 targets the HER2 protein expressed in 75% of breast cancers, addressing a significant unmet need among approximately 300,000 new breast cancer patients annually in the U.S.
- Noble Capital Markets has initiated equity research coverage on the company, highlighting the clinical and commercial potential of this novel immunotherapy approach.Greenwich LifeSciences Builds Internal Clinical Team to Reduce Costs and Enhance FLAMINGO-01 Breast Cancer Trial Operations- Greenwich LifeSciences is transitioning from external Clinical Research Organizations to an internal clinical trial management team for its Phase III FLAMINGO-01 study to reduce costs and improve efficiency.
- The strategic shift aims to lower the company's baseline burn rate while enhancing data quality and site monitoring capabilities for the breast cancer immunotherapy trial.
- The internal team expansion positions Greenwich to potentially conduct multiple simultaneous trials and manage additional pipeline indications or in-licensed drug candidates more cost-effectively.
- FLAMINGO-01 is evaluating GLSI-100 immunotherapy in HER2-positive breast cancer patients, with plans to enroll approximately 750 patients across up to 150 global sites.Greenwich LifeSciences Expands Phase III Breast Cancer Trial Globally, Adds New Sites and Expertise- Greenwich LifeSciences broadens its Phase III FLAMINGO-01 trial for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrence, by adding new clinical sites in the U.S. and Europe.
- The trial expands into France through a partnership with Unicancer, activating 19 sites, and collaborates with GBG in Germany, adding approximately 38 sites to the study.
- Harvard and Johns Hopkins join the trial in the U.S., with principal investigators Dr. Laura Spring and Dr. Cesar Santa-Maria joining the Steering Committee.
- EMA approves the addition of 11 sites in Spain, Germany, and Poland, potentially activating 110-115 sites in Europe, with plans to expand to Ireland, Romania, and other countries.
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