Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
Greenwich LifeSciences, Inc. (Voir sur ClinicalTrials)
août 2022
décembre 2026
02 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:08 | Contact (sur clinicalTrials) | |||
| CLCC RENE HUGUENIN INSTITUT CURIE | 10/04/2025 13:11:55 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| HOPITAL NOVO | vendredi 5 septembre 2025 | Contact (sur clinicalTrials) | |||
Critères
Tous
- 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 for
all tumors biopsied (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.