Breast Cancer Clinical Trial
— FLAMINGO-01Official title:
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)
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.
| Status | Recruiting |
| Enrollment | 598 |
| Est. completion date | December 2026 |
| Est. primary completion date | December 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility | 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 - 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 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Sainte-Catherine - Institut du Cancer Avignon-Provence (ICAP) | Avignon | |
| France | Centre Hospitalier Simone Veil de Beauvais | Beauvais | |
| France | Clinique Pasteur-Lanroze | Brest | |
| France | Centre François Baclesse (CLCC) | Caen | |
| France | Pôle Santé République - ELSAN | Clermont-Ferrand | |
| France | Hôpital privé Drôme Ardèche | Guilherand-Granges | |
| France | Centre Hospitalier Universitaire (CHU) à Limoges | Limoges | |
| France | Centre Léon Bérard | Lyon | |
| France | Centre Antoine Lacassagne | Nice | |
| France | Centre Hospitalier Privé Sainte-Marie Osny | Osny | |
| France | Institut Curie | Paris | |
| France | Hôpital NOVO (Nord-Ouest Val-d'Oise) | Pontoise | |
| France | Centre Hospitalier Intercommunal de Cornouaille Quimper Concarneau (CHIC) | Quimper | |
| France | Institut Godinot (CLCC) | Reims | |
| France | Centre Eugène Marquis (CLCC) | Rennes | |
| France | Institut Curie | Saint-Cloud | |
| France | Centre Hospitalier Privé Saint-Grégoire | Saint-Grégoire | |
| France | Centre Hospitalier Universitaire de Saint-Étienne | Saint-Priest-en-Jarez | |
| France | Institut de cancérologie Strasbourg Europe | Strasbourg | |
| France | Hôpital Robert Schuman | Vantoux | |
| France | Institut Gustave Roussy | Villejuif | |
| Germany | Hämatologie-Onkologie im Zentrum MVZ | Augsburg | |
| Germany | Klinikum Bayreuth | Bayreuth | |
| Germany | DBZ Onkologie | Berlin | |
| Germany | Städtisches Klinikum Dessau | Dessau | |
| Germany | Universitätsklinikum Carl Gustav Carus Dresden | Dresden | |
| Germany | MVZ Medical Center Düsseldorf | Düsseldorf | |
| Germany | Studienzentrale für das MVZ Eggenfelden e.K. | Eggenfelden | |
| Germany | Kliniken Essen-Mitte | Essen | |
| Germany | Klinikum Frankfurt Höchst | Frankfurt | |
| Germany | Praxis für interdisziplinäre Onkologie & Hämatologie | Freiburg | |
| Germany | Helios Klinikum Gifhorn | Gifhorn | |
| Germany | Universitätsmedizin Göttingen | Göttingen | |
| Germany | Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) | Halle | |
| Germany | Mammazentrum Hamburg | Hamburg | |
| Germany | Gynäkologische Praxisklinik Hamburg Harburg | Hamburg-Harburg | |
| Germany | National Center for Tumor Diseases (NCT) Heidelberg | Heidelberg | |
| Germany | Elisabeth-Krankenhaus Kassel | Kassel | |
| Germany | Gemeinschaftspraxis für Hämatologie und Onkologie | Langen | |
| Germany | MVM Medizinische Verwaltungs- und Managementgesellschaft | Leer | |
| Germany | RKH Kliniken Ludwigsburg-Bietigheim | Ludwigsburg | |
| Germany | Universitätsmedizin der Johannes Gutenberg Universität Mainz KöR | Mainz | |
| Germany | Universität Heidelberg | Mannheim | |
| Germany | München Klinik | Munich | |
| Germany | Klinikum Südstadt Rostock | Rostock | |
| Germany | Gesundheits- und Pflegezentrum Rüsselsheim | Rüsselsheim | |
| Germany | Diakonissen-Stiftungs-Krankenhaus Speyer (Brustzentrum) | Speyer | |
| Germany | Klinikum Mutterhaus der Borromäerinnen | Trier | |
| Germany | Universitätsklinikum Ulm | Ulm | |
| Germany | Marien Hospital Witten | Witten | |
| Germany | Klinikum Worms | Worms | |
| Germany | Helios Universitätsklinikum Wuppertal | Wuppertal | |
| Italy | Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico) | Bologna | |
| Italy | Ospedale Policlinico San Martino IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico) | Genova | |
| Italy | Humanitas Research Hospital | Milan | |
| Italy | Azienda Ospedaliera Universitaria Federico II Di Napoli | Naples | |
| Italy | Istituto Nazionale Tumori Fondazione Pascale IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico) | Naples | |
| Italy | Azienda Ospedaliero Universitaria Maggiore della Carità di Novara | Novara | |
| Italy | Istituto Oncologico Veneto | Padova | |
| Italy | Istituti Clinici Scientifici Maugeri Spa Società Benefit IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico) | Pavia | |
| Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico) | Rome | |
| Poland | Samodzielny Publiczny Zaklad Opieki Zdrowotnej (ZOZ) Szpital Uniwersytecki w Krakowie | Kraków | |
| Poland | Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie | Kraków | |
| Poland | Instytut Centrum Zdrowia Matki Polki (ICZMP) | Lódz | |
| Poland | Samodzielny Publiczny Zaklad Opieki Zdrowotnej (SPOZOZ) Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu | Opole | |
| Poland | Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan | |
| Poland | Centrum Medyczne MrukMed | Rzeszów | |
| Poland | Zachodniopomorskie Centrum Onkologii | Szczecin | |
| Spain | Complejo Hospitalario Universitario de Albacete | Albacete | |
| Spain | Hospital General Universitario Dr. Balmis | Alicante | |
| Spain | Hospital Universitario de Badajoz | Badajoz | |
| Spain | Hospital Clínic De Barcelona | Barcelona | |
| Spain | Hospital del Mar | Barcelona | |
| Spain | Hospital San Pedro de Alcántara | Cáceres | |
| Spain | Hospital Universitario Reina Sofía | Córdoba | |
| Spain | Hospital Clínico Universitario Virgen de la Arrixaca | El Palmar | |
| Spain | Hospital Universitario de Fuenlabrada | Fuenlabrada | |
| Spain | Hospital Galdakao-Usansolo | Galdakao | |
| Spain | Hospital Universitario Clínico San Cecilio | Granada | |
| Spain | Hospital Universitario de Jaén | Jaén | |
| Spain | Hospital Universitario de Jerez de la Frontera | Jerez De La Frontera | |
| Spain | Hospital Universitario de Canarias | La Laguna | |
| Spain | Hospital Universitari Arnau de Vilanova (Lleida) | Lleida | |
| Spain | Hospital General Universitario Gregorio Marañón | Madrid | |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario Fundación Jiménez Díaz | Madrid | |
| Spain | Hospital Universitario HM Sanchinarro | Madrid | |
| Spain | Hospital Universitario Infanta Leonor | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | |
| Spain | Hospital Regional Universitario de Malaga | Málaga | |
| Spain | Althaia, Xarxa Assistencial Universitària de Manresa | Manresa | |
| Spain | Hospital General Universitario Morales Meseguer | Murcia | |
| Spain | Hospital Universitari Son Espases | Palma De Mallorca | |
| Spain | Hospital Universitario San Juan de Alicante | San Juan De Alicante | |
| Spain | Hospital Universitario Donostia | San Sebastián | |
| Spain | Hospital Universitari General de Catalunya - Grupo Quirónsalud | Sant Cugat Del Vallès | |
| Spain | Hospital Universitario Nuestra Señora de Candelaria | Santa Cruz De Tenerife | |
| Spain | Hospital Clínico Universitario de Santiago | Santiago de Compostela | |
| Spain | Hospital Universitario Virgen del Rocío | Sevilla | |
| Spain | Hospital Universitario Virgen Macarena | Sevilla | |
| Spain | Hospital Universitario de Toledo | Toledo | |
| Spain | Consorcio Hospital General Universitario de Valencia | Valencia | |
| Spain | Fundación Instituto Valenciano de Oncología | Valencia | |
| Spain | Hospital Clínico Universitario de Valencia | Valencia | |
| Spain | Hospital Universitari Arnau de Vilanova (Valencia) | Valencia | |
| Spain | Hospital Universitario Miguel Servet | Zaragoza | |
| United States | Maryland Oncology Hematology (USOR) | Annapolis | Maryland |
| United States | Texas Oncology - Austin | Austin | Texas |
| United States | Comprehensive Blood and Cancer Center | Bakersfield | California |
| United States | Northwestern University | Chicago | Illinois |
| United States | Oncology Hematology Care Clinical Trials | Cincinnati | Ohio |
| United States | New York Oncology | Clifton Park | New York |
| United States | University of Miami | Coral Gables | Florida |
| United States | Texas Oncology - Dallas (USOR) | Dallas | Texas |
| United States | Texas Oncology - Dallas Presbyterian Hospital | Dallas | Texas |
| United States | The University of Texas Southwestern Medical Center | Dallas | Texas |
| United States | Rocky Mountain Cancer Centers | Denver | Colorado |
| United States | Virginia Cancer Specialists | Fairfax | Virginia |
| United States | Providence Medical Foundation | Fullerton | California |
| United States | Comprehensive Cancer Centers of Nevada | Henderson | Nevada |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | University of California, Los Angeles | Los Angeles | California |
| United States | University of Southern California | Los Angeles | California |
| United States | Redeemer Health | Meadowbrook | Pennsylvania |
| United States | Yale University | New Haven | Connecticut |
| United States | Columbia University | New York | New York |
| United States | Nebraska Cancer Specialists (USOR) | Omaha | Nebraska |
| United States | University of Nebraska Medical Center | Omaha | Nebraska |
| United States | Stanford Women's Cancer Center | Palo Alto | California |
| United States | Washington University Siteman Cancer Center | Saint Louis | Missouri |
| United States | University of Utah Huntsman Cancer Institute | Salt Lake City | Utah |
| United States | Texas Oncology San Antonio (USOR) | San Antonio | Texas |
| United States | University of California, San Francisco Helen Diller Family Cancer Center | San Francisco | California |
| United States | Stony Brook University | Stony Brook | New York |
| United States | Texas Oncology - Gulf Coast | Sugar Land | Texas |
| United States | Moffitt Cancer Center | Tampa | Florida |
| United States | Compass Oncology (USOR) | Tigard | Oregon |
| United States | Torrance Memorial Physicians Network | Torrance | California |
| United States | Arizona Oncology Associates, PC - HOPE | Tucson | Arizona |
| United States | Texas Oncology - Tyler (USOR) | Tyler | Texas |
| United States | PIH Hospital - Whittier | Whittier | California |
| Lead Sponsor | Collaborator |
|---|---|
| Greenwich LifeSciences, Inc. |
United States, France, Germany, Italy, Poland, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Immune Response Measurements | Immune response will be measured by Delayed-Type Hypersensitivity (DTH) tests and immunologic assays. | 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 | |
| Primary | Invasive Breast Cancer-free Survival (IBCFS) | 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. | Median 4 years of follow-up (interim analysis planned) | |
| Secondary | Invasive Disease-free Survival (IDFS) | 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. | Median 4 years of follow-up (interim analysis planned) | |
| Secondary | Distant Disease-free Survival (DDFS) | DDFS will be defined as the time from the first dose of study medication to the time of distant disease recurrence or death. | Median 4 years of follow-up (interim analysis planned) | |
| Secondary | Overall Survival | Overall survival will be defined as the time from the first dose of study medication until death from any cause. | Median 4 years of follow-up (interim analysis planned) | |
| Secondary | Quality of Life Questionnaire Core 30 (QLQ-C30) | European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) | Baseline and 36 months | |
| Secondary | Quality of Life FACT-GP5 | FACT-GP5 to assess global side effect impact | Baseline and 36 months |
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