Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects (FLAMINGO-01)
August 4, 2026 updated by: Greenwich LifeSciences, Inc.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
2250
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jaye L Thompson, Ph.D.
- Phone Number: (832) 791-2542
- Email: Jaye.Thompson@GreenwichLifeSciences.com
Study Locations
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-
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Leuven, Belgium
- Recruiting
- UZ Leuven
-
-
-
-
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Avignon, France
- Recruiting
- Sainte-Catherine - Institut du Cancer Avignon-Provence (ICAP)
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Brest, France
- Recruiting
- Clinique Pasteur-Lanroze
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Caen, France
- Recruiting
- Centre François Baclesse (CLCC)
-
Chambray-lès-Tours, France
- Recruiting
- Pole Sante Leonard de Vinci
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Cholet, France
- Recruiting
- Centre Hospitalier de Cholet
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Contamine-sur-Arve, France
- Recruiting
- Centre Hospitalier Alpes Leman
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Lyon, France
- Recruiting
- Centre Léon Bérard
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Nantes, France
- Recruiting
- Hopital prive du Confluent
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Osny, France
- Recruiting
- Centre Hospitalier Privé Sainte-Marie Osny
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Paris, France
- Recruiting
- Institut Curie
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Pierre-Bénite, France
- Not yet recruiting
- Hospices Civils de Lyon
-
Pontoise, France
- Recruiting
- Hôpital NOVO (Nord-Ouest Val-d'Oise)
-
Reims, France
- Recruiting
- Institut Jean Godinot (CLCC)
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Saint-Cloud, France
- Recruiting
- Institut Curie
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Saint-Grégoire, France
- Recruiting
- Centre Hospitalier Prive Saint-Gregoire
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Saint-Priest-en-Jarez, France
- Recruiting
- Centre Hospitalier Universitaire de Saint-Étienne
-
Strasbourg, France
- Recruiting
- Centre Lutte Contre le Cancer Paul Strauss
-
Valence, France
- Recruiting
- Hopital Prive Drome Ardeche
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Vantoux, France
- Recruiting
- Hopitaux Prives De Metz
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Villejuif, France
- Recruiting
- Institut Gustave Roussy
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-
-
-
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Augsburg, Germany
- Recruiting
- Haematologie-Onkologie im Zentrum MVZ GmbH
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Bayreuth, Germany
- Not yet recruiting
- Klinikum Bayreuth GmbH
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Berlin, Germany
- Recruiting
- Helios Klinikum Berlin-Buch GmbH
-
Bottrop, Germany
- Recruiting
- Marienhospital Bottrop gGmbH
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Braunschweig, Germany
- Not yet recruiting
- Studien GbR Braunschweig
-
Bremen, Germany
- Recruiting
- Evangelisches Diakonie-Krankenhaus gGmbH
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Chemnitz, Germany
- Not yet recruiting
- Klinikum Chemnitz gGmbH
-
Dessau, Germany
- Recruiting
- Städtisches Klinikum Dessau
-
Dortmund, Germany
- Not yet recruiting
- Klinikum Dortmund gGmbH
-
Dresden, Germany
- Not yet recruiting
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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Düsseldorf, Germany
- Recruiting
- Kostara Gyn Oncology Clinic Research UG
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Eggenfelden, Germany
- Recruiting
- Studienzentrale für das MVZ Eggenfelden e.K.
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Essen, Germany
- Recruiting
- Evangelisches Kliniken Essen-Mitte gGmbH
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Frankfurt, Germany
- Recruiting
- Klinikum Frankfurt Höchst GmbH
-
Freiburg im Breisgau, Germany
- Recruiting
- Praxis für Interdisziplinäre Onkologie und Haematologie GbR
-
Gifhorn, Germany
- Recruiting
- Helios Klinikum Gifhorn GmbH
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Göttingen, Germany
- Recruiting
- Universitätsmedizin Göttingen
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Halle, Germany
- Recruiting
- Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
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Hamburg, Germany
- Recruiting
- Mammazentrum Hamburg MVZ GbR
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Harburg, Germany
- Recruiting
- Gynäkologische Praxisklinik Hamburg-Harburg
-
Heidelberg, Germany
- Recruiting
- National Center for Tumor Diseases (NCT) Heidelberg
-
Hildesheim, Germany
- Not yet recruiting
- Frauenärzte am Bahnhofsplatz Hildesheim
-
Kassel, Germany
- Recruiting
- Elisabeth Krankenhaus GmbH
-
Krefeld, Germany
- Recruiting
- MVZ GynKrefeld GmbH
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Ludwigsburg, Germany
- Recruiting
- RKH Klinken Ludwigsburg-Bietigheim gGmbH
-
Mainz, Germany
- Recruiting
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
-
Mannheim, Germany
- Recruiting
- Heidelberg University
-
Mayen, Germany
- Not yet recruiting
- Hämatologisch Onkologisches Forschungsinstitut
-
Munich, Germany
- Not yet recruiting
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
-
Munich, Germany
- Recruiting
- München Klinik gGmbH
-
Münster, Germany
- Not yet recruiting
- Universitätsklinikum Münster
-
Rheine, Germany
- Not yet recruiting
- Klinikum Rheine / Mathias-Spital Rheine
-
Rostock, Germany
- Recruiting
- Klinikum Südstadt Rostock Eigenbetrieb der Hanse und Universitätsstadt Rostock
-
Rüsselsheim am Main, Germany
- Recruiting
- Gesundheits und Pflegezentrum Ruesselsheim gGmbH
-
Trier, Germany
- Recruiting
- Klinikum Mutterhaus der Borromaerinnen gGmbH
-
Ulm, Germany
- Recruiting
- Universitätsklinikum Ulm AöR
-
Walsrode, Germany
- Not yet recruiting
- MVZ Walsrode
-
Weiden, Germany
- Not yet recruiting
- MVZ Nordoberpfalz GmbH
-
Witten, Germany
- Recruiting
- Marienhospital Witten
-
Worms, Germany
- Recruiting
- Klinikum Worms gGmbH
-
Wuppertal, Germany
- Recruiting
- Helios Universitätsklinikum Wuppertal
-
-
-
-
-
Dublin, Ireland
- Recruiting
- St. Vincent's University Hospital
-
-
-
-
-
Bologna, Italy
- Recruiting
- Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
-
Genova, Italy
- Recruiting
- Ospedale Policlinico San Martino IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
-
Milan, Italy
- Not yet recruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori
-
Modena, Italy
- Not yet recruiting
- Azienda Ospedaliero-Universitaria Policlinico di Modena
-
Naples, Italy
- Recruiting
- Azienda Ospedaliera Universitaria Federico II di Napoli
-
Naples, Italy
- Recruiting
- Istituto Nazionale Tumori Fondazione Pascale IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
-
Novara, Italy
- Recruiting
- Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
-
Padova, Italy
- Recruiting
- Istituto Oncologico Veneto
-
Pavia, Italy
- Recruiting
- Istituti Clinici Scientifici Maugeri Spa Società Benefit IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
-
Pisa, Italy
- Recruiting
- Azienda Ospedaliero Universitaria Pisana
-
Rome, Italy
- Recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
-
-
-
-
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Gdansk, Poland
- Not yet recruiting
- Copernicus Podmiot Leczniczy Sp. z o.o. Wojewódzkie Centrum Onkologii
-
Konin, Poland
- Recruiting
- Przychodnia Lekarska KOMED Roman Karaszewski
-
Krakow, Poland
- Recruiting
- Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
-
Krakow, Poland
- Recruiting
- Samodzielny Publiczny Zakład Opieki Zdrowotnej (ZOZ) Szpital Uniwersytecki w Krakowie
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Opole, Poland
- Recruiting
- Samodzielny Publiczny Zakład Opieki Zdrowotnej (SPOZOZ) Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
-
Poznan, Poland
- Recruiting
- Uniwersytecki Szpital Kliniczny W Poznaniu
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Rzeszów, Poland
- Recruiting
- Centrum Medyczne MrukMed
-
Słupsk, Poland
- Recruiting
- Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku
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Warsaw, Poland
- Recruiting
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
-
-
-
-
-
Lisbon, Portugal
- Recruiting
- Unidade Local de Saúde Santa Maria, E.P.E.
-
-
-
-
-
Bucharest, Romania
- Recruiting
- Filantropia Clinical Hospital
-
Bucharest, Romania
- Recruiting
- Clinica Neolife Băneasa București
-
Cluj-Napoca, Romania
- Recruiting
- Institute of Oncology "Prof Dr Ion Chiricuta"
-
Timișoara, Romania
- Recruiting
- Oncomed SRL - Oncology Center
-
-
-
-
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Albacete, Spain
- Recruiting
- Complejo Hospitalario Universitario de Albacete
-
Alicante, Spain
- Recruiting
- Hospital General Universitario Dr. Balmis
-
Badajoz, Spain
- Recruiting
- Hospital Universitario de Badajoz
-
Barcelona, Spain
- Recruiting
- Hospital del Mar
-
Barcelona, Spain
- Recruiting
- Hospital Clinic de Barcelona
-
Cáceres, Spain
- Recruiting
- Hospital San Pedro De Alcantara
-
Córdoba, Spain
- Recruiting
- Hospital Universitario Reina Sofia
-
El Palmar, Spain
- Recruiting
- Hospital Clinico Universitario Virgen de La Arrixaca
-
Fuenlabrada, Spain
- Recruiting
- Hospital Universitario de Fuenlabrada
-
Galdakao, Spain
- Recruiting
- Hospital Galdakao-Usansolo
-
Granada, Spain
- Recruiting
- Hospital Universitario Clínico San Cecilio
-
Jaén, Spain
- Recruiting
- Hospital Universitario de Jaén
-
Jerez de la Frontera, Spain
- Recruiting
- Hospital Universitario de Jerez de la Frontera
-
Lleida, Spain
- Recruiting
- Hospital Universitari Arnau de Vilanova (Lleida)
-
Madrid, Spain
- Recruiting
- Hospital Universitario 12 de Octubre
-
Madrid, Spain
- Recruiting
- Hospital General Universitario Gregorio Marañon
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Madrid, Spain
- Recruiting
- Hospital Universitario De La Princesa
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Madrid, Spain
- Recruiting
- Hospital Universitario Fundacion Jimenez Diaz
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Madrid, Spain
- Recruiting
- Hospital Universitario HM Sanchinarro
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Majadahonda, Spain
- Recruiting
- Hospital Universitario Puerta de Hierro Majadahonda
-
Manresa, Spain
- Recruiting
- Althaia Xarxa Assistencial Universitària de Manresa
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Murcia, Spain
- Recruiting
- Hospital General Universitario Morales Meseguer
-
Málaga, Spain
- Recruiting
- Hospital Regional Universitario de Malaga
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Málaga, Spain
- Recruiting
- Hospital Clinico Universitario Virgen de la Victoria
-
Palma de Mallorca, Spain
- Recruiting
- Hospital Universitari Son Espases
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Reus, Spain
- Recruiting
- Hospital Universitario Sant Joan de Reus
-
Sabadell, Spain
- Recruiting
- Consorci Corporació Sanitària Parc Taulí
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San Cristóbal de La Laguna, Spain
- Recruiting
- Hospital Universitario de Canarias
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San Sebastián, Spain
- Recruiting
- Hospital Universitario Donostia
-
Sant Cugat del Vallès, Spain
- Recruiting
- Hospital Universitari General de Catalunya - Grupo Quirónsalud
-
Sant Joan d'Alacant, Spain
- Recruiting
- Hospital Universitario San Juan de Alicante
-
Santiago de Compostela, Spain
- Recruiting
- Hospital Clinico Universitario de Santiago
-
Seville, Spain
- Recruiting
- Hospital Universitario Virgen Macarena
-
Seville, Spain
- Recruiting
- Hospital Universitario Virgen del Rocio
-
Toledo, Spain
- Recruiting
- Hospital Universitario de Toledo
-
Valencia, Spain
- Recruiting
- Hospital Clinico Universitario de Valencia
-
Valencia, Spain
- Recruiting
- Consorcio Hospital General Universitario De Valencia
-
Valencia, Spain
- Not yet recruiting
- Hospital Universitari Arnau de Vilanova (Valencia)
-
Zaragoza, Spain
- Recruiting
- Hospital Clinico Universitario Lozano Blesa
-
Zaragoza, Spain
- Recruiting
- Hospital Universitario Miguel Servet
-
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-
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Alabama
-
Mobile, Alabama, United States, 36607
- Not yet recruiting
- Southern Cancer Center
-
Principal Investigator:
- Michael Meshad
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Arizona
-
Goodyear, Arizona, United States, 85338
- Recruiting
- City of Hope - Cancer Center Phoenix
-
Principal Investigator:
- Hope Rugo, MD
-
Contact:
- Felicia Lewis
- Email: flewis@coh.org
-
Contact:
- Jenny Sanchez
- Email: jesanchez@coh.org
-
Tucson, Arizona, United States, 85704
- Recruiting
- Tucson Medical Center Healthcare
-
Principal Investigator:
- Aisha Ahmed, MD
-
Contact:
- Stacey Kimbell, R.N.
- Email: stacey.kimbell@tmcaz.com
-
-
California
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Duarte, California, United States, 91010
- Recruiting
- City of Hope - Duarte Cancer Center
-
Principal Investigator:
- Hope Rugo, MD
-
Contact:
- Felicia Lewis
- Email: flewis@coh.org
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Contact:
- Jenny Sanchez
- Email: jesanchez@coh.org
-
Fullerton, California, United States, 92835
- Recruiting
- Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center
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Contact:
- Linda Gozar
- Email: linda.gozar@stjoe.org
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Contact:
- Rebeca Sanchez
- Phone Number: 714 446-5177
- Email: rebeca.sanchez2@providence.org
-
Principal Investigator:
- Monica E Lee, MD
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Irvine, California, United States, 92618
- Recruiting
- City of Hope - Orange County Lennar Foundation Cancer Center
-
Principal Investigator:
- Hope Rugo, MD
-
Contact:
- Felicia Lewis
- Email: flewis@coh.org
-
Contact:
- Jenny Sanchez
- Email: jesanchez@coh.org
-
La Jolla, California, United States, 92093
- Recruiting
- University of California San Diego - Moores Cancer Center
-
Contact:
- Sauntee Braddock
- Phone Number: 858-534-8248
- Email: sbraddock@health.ucsd.edu
-
Principal Investigator:
- Rebecca Shatsky, MD
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Los Angeles, California, United States, 90033
- Active, not recruiting
- University of Southern California - Norris Comprehensive Cancer Center
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Palo Alto, California, United States, 74304
- Recruiting
- Stanford Medicine Cancer Center - Stanford Women's Cancer Center
-
Principal Investigator:
- Fauzia Riaz, MD
-
Contact:
- Michelle Narayan Brauer
- Phone Number: 650-721-4076
- Email: narayanm@stanford.edu
-
San Francisco, California, United States, 94158
- Recruiting
- University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
-
Contact:
- Amy Deluca
- Phone Number: 415-353-7288
- Email: amy.deluca@ucsf.edu
-
Principal Investigator:
- Laura Huppert, MD
-
Santa Monica, California, United States, 90404
- Recruiting
- University of California Los Angeles - Hematology / Oncology Parkside
-
Contact:
- Monica Rocha
- Email: mprocha@mednet.UCLA.edu
-
Principal Investigator:
- Aashni Master, DO
-
Whittier, California, United States, 90602
- Recruiting
- PIH Health Hospital - Whittier Hospital
-
Principal Investigator:
- Lisa Wang, MD
-
Contact:
- Kristine Bradbury
- Email: kristine.bradbury@pihhealth.org
-
-
Colorado
-
Denver, Colorado, United States, 80220
- Recruiting
- Rocky Mountain Cancer Centers
-
Principal Investigator:
- Mabel Mardones, MD
-
Contact:
- Jennifer Hege
- Email: jennifer.hege@usoncology.com
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- Recruiting
- Yale Cancer Center - Smilow Cancer Hospital
-
Contact:
- Adam Blanchard
- Email: adam.blanchard@yale.edu
-
Principal Investigator:
- Michael DiGiovanna, MD, PhD
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20016
- Recruiting
- Johns Hopkins Medicine - Kimmel Cancer Center-Sibley Memorial Hospital
-
Principal Investigator:
- Cesar Santa-Maria, MD
-
Contact:
- Hayden Chae, RN
- Phone Number: 202-364-7620
- Email: hchae5@jhmi.edu
-
-
Florida
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Miami, Florida, United States, 33146
- Recruiting
- University of Miami - Sylvester Comprehensive Cancer Center
-
Principal Investigator:
- Elisa Krill-Jackson, MD
-
Contact:
- Maria Ferrer-Guerra
- Email: mtf89@med.miami.edu
-
Tampa, Florida, United States, 33612
- Recruiting
- Moffitt Cancer Center
-
Contact:
- Julian Guerrero
- Email: julian.guerrero@moffitt.org
-
Principal Investigator:
- Aixa Soyano Muller, MD
-
-
Georgia
-
Newnan, Georgia, United States, 30265
- Recruiting
- City of Hope - Cancer Center Atlanta
-
Principal Investigator:
- Hope Rugo, MD
-
Contact:
- Felicia Lewis
- Email: flewis@coh.org
-
Contact:
- Jenny Sanchez
- Email: jesanchez@coh.org
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University - Northwestern Memorial Hospital
-
Principal Investigator:
- William Gradishar, MD
-
Contact:
-
Zion, Illinois, United States, 60099
- Recruiting
- City of Hope - Cancer Center Chicago
-
Principal Investigator:
- Hope Rugo, MD
-
Contact:
- Felicia Lewis
- Email: flewis@coh.org
-
Contact:
- Jenny Sanchez
- Email: jesanchez@coh.org
-
-
Maryland
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Annapolis, Maryland, United States, 21401
- Recruiting
- Maryland Oncology Hematology
-
Principal Investigator:
- Jeanine Werner, MD
-
Contact:
- Gloria Seho-Ahiable
- Email: gloria.seho-ahiable@usoncology.com
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital Cancer Center
-
Principal Investigator:
- Laura Spring, MD
-
Contact:
- MGH Cancer Center New Patient Access Team
- Phone Number: 877-394-5128
-
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Minnesota
-
Maple Grove, Minnesota, United States, 55369
- Recruiting
- Minnesota Oncology
-
Contact:
- Kayla McDonald
- Email: kayla.mcdonald1@usoncology.com
-
Principal Investigator:
- Nicole Jacobi, MD
-
-
Missouri
-
St Louis, Missouri, United States, 63110
- Recruiting
- Siteman Cancer Center - Washington University Medical Campus
-
Principal Investigator:
- Faisal Fa'ak, MD
-
Contact:
- Tracy Summa
- Phone Number: 314-362-0263
- Email: tracy.summa@wustl.edu
-
-
Nebraska
-
Omaha, Nebraska, United States, 68114
- Recruiting
- Nebraska Cancer Specialists
-
Contact:
- Heather Cordes
- Email: hcordes@nebraskacancer.com
-
Principal Investigator:
- Mary Heurter Wells, MD
-
Omaha, Nebraska, United States, 68198
- Recruiting
- Nebraska Medicine - University of Nebraska Medical Center
-
Contact:
- Email: meghana.kesireddy@unmc.edu
-
Principal Investigator:
- Meghana Kesireddy, MBBS
-
-
Nevada
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Henderson, Nevada, United States, 89052
- Recruiting
- Comprehensive Cancer Centers of Nevada
-
Contact:
- Ann Lovelace
- Email: ann.lovelace@usoncology.com
-
Principal Investigator:
- Stephani Christensen, MD
-
-
New Jersey
-
Camden, New Jersey, United States, 08103
- Active, not recruiting
- Cooper University Health Care
-
-
New York
-
Albany, New York, United States, 12065
- Recruiting
- New York Oncology Hematology
-
Principal Investigator:
- Karen Tedesco, MD
-
Contact:
- Josephine Faruol
- Email: josephine.faruol@nyoh.com
-
New York, New York, United States, 10032
- Recruiting
- New York-Presbyterian - Columbia University Irving Medical Center
-
Contact:
-
Principal Investigator:
- Julia McGuinness, MD
-
Stony Brook, New York, United States, 11794
- Recruiting
- Stony Brook University Cancer Center
-
Principal Investigator:
- Jules Cohen, MD
-
Contact:
- Pushpa Talanki
- Email: pushpa.talanki@stonybrookmedicine.edu
-
Contact:
- Jules Cohen
- Email: jules.cohen@stonybrookmedicine.edu
-
-
Ohio
-
Cincinnati, Ohio, United States, 45211
- Recruiting
- Oncology Hematology Care
-
Contact:
- Douglas Hart
- Email: douglas.hart@usoncology.com
-
Principal Investigator:
- Patrick Ward, MD, PhD
-
-
Oregon
-
Medford, Oregon, United States, 97504
- Not yet recruiting
- Hematology Oncology Associates
-
Principal Investigator:
- Cho, MD
-
Tigard, Oregon, United States, 97223
- Recruiting
- Compass Oncology - Northwest Cancer Specialists
-
Principal Investigator:
- Jay Andersen, MD
-
Contact:
- Jennifer Thompson
- Email: Jennifer.Thompson@usoncology.com
-
-
Pennsylvania
-
Meadowbrook, Pennsylvania, United States, 19046
- Recruiting
- Redeemer Health - Holy Redeemer Hospital
-
Contact:
- Nadine Varney
- Phone Number: 215 544-5832
- Email: nvarney@holyredeemer.com
-
Principal Investigator:
- Rabia Cattie, MD
-
Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Sidney Kimmel Comprehensive Cancer Center - Thomas Jefferson University Hospital
-
Principal Investigator:
- Maysa Abu-Khalaf, MD
-
Contact:
- Phone Number: 215-600-9151
- Email: onctrialnow@jefferson.edu
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37909
- Not yet recruiting
- Tennessee Cancer Specialists
-
Principal Investigator:
- R. David Schumaker, MD
-
Nashville, Tennessee, United States, 37203
- Not yet recruiting
- SCRI Oncology Partners
-
Principal Investigator:
- Denise A Yardley, MD
-
-
Texas
-
Austin, Texas, United States, 78745
- Recruiting
- Texas Oncology - Austin
-
Contact:
- Sara Manning
- Email: sara.manning@usoncology.com
-
Principal Investigator:
- Kathryn Hudson, MD
-
Dallas, Texas, United States, 75246
- Recruiting
- Texas Oncology - Baylor Charles A. Sammons Cancer Center
-
Principal Investigator:
- Cynthia Osborne, MD
-
Contact:
- Christine Terraciano
- Email: Christine.Terraciano@usoncology.com
-
Dallas, Texas, United States, 75390
- Recruiting
- The University of Texas Southwestern Medical Center
-
Principal Investigator:
- Nisha Unni, MD
-
Contact:
- Meredith Carter
- Email: meredith.carter@utsouthwestern.edu
-
Dallas, Texas, United States, 75231
- Recruiting
- Texas Oncology - Dallas Presbyterian Hospital
-
Principal Investigator:
- Cynthia Osborne, MD
-
Contact:
- Nancy Jones
- Email: nancy.jones@usoncology.com
-
Houston, Texas, United States, 77057
- Recruiting
- Baylor College of Medicine - Dan L. Duncan Comprehensive Cancer Center
-
Principal Investigator:
- Mothaffar Rimawi, MD
-
Contact:
- Maria Rodriguez
- Email: maria.rodriguez3@bcm.edu
-
San Antonio, Texas, United States, 78240
- Recruiting
- Texas Oncology - San Antonio Medical Center
-
Principal Investigator:
- Emmalind Aponte, MD
-
Contact:
- Shannon Syring
- Email: shannon.syring@usoncology.com
-
San Antonio, Texas, United States, 78229
- Recruiting
- The University of Texas Health Sciences Center at San Antonio - Mays Cancer Center
-
Principal Investigator:
- Virginia Kaklamani, MD
-
Contact:
- Epp Goodwin
- Phone Number: 210-450-5798
- Email: goodwine@uthscsa.edu
-
Sugar Land, Texas, United States, 77479
- Recruiting
- Texas Oncology - Gulf Coast
-
Principal Investigator:
- Jorge Darcourt, MD
-
Contact:
- Melissa Howell
- Email: melissa.howell@usoncology.com
-
Tyler, Texas, United States, 75702
- Recruiting
- Texas Oncology - Tyler
-
Principal Investigator:
- Nanna Sulai, MD
-
Contact:
- Shelly Maxfield
- Email: shelly.maxfield@usoncology.com
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Recruiting
- University of Utah - Huntsman Cancer Institute
-
Contact:
- Janna Espinosa
- Email: janna.espinosa@hci.utah.edu
-
Principal Investigator:
- Mei Wei, MD
-
-
Virginia
-
Fairfax, Virginia, United States, 22031
- Recruiting
- Virginia Cancer Specialists
-
Contact:
- Carrie Friedman
- Email: carrie.friedman@usoncology.com
-
Principal Investigator:
- Shruti Tiwari, MD
-
Norfolk, Virginia, United States, 23502
- Not yet recruiting
- Virginia Oncology Associates
-
Principal Investigator:
- Nino Balanchivadze, MD
-
Winchester, Virginia, United States, 22601
- Not yet recruiting
- Shenandoah Oncology
-
Principal Investigator:
- Kristine Reed, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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)
|
500 mcg/mL GP2 and 125 mcg/mL GM-CSF
|
|
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)
|
0.9% Normal Saline
|
|
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)
|
500 mcg/mL GP2 and 125 mcg/mL GM-CSF
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Invasive Breast Cancer-free Survival (IBCFS)
Time Frame: Median 4 years of follow-up (interim analyses planned)
|
IBCFS is defined as the time from randomization (or the first dose of study medication if in the non-randomized arm) 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 (STEEP version 2).
|
Median 4 years of follow-up (interim analyses planned)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life Questionnaire Core 30 (QLQ-C30)
Time Frame: Baseline and 36 months
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
|
Baseline and 36 months
|
|
Quality of Life FACT-GP5
Time Frame: Baseline and 36 months
|
FACT-GP5 to assess global side effect impact
|
Baseline and 36 months
|
|
Invasive Disease-free Survival (IDFS)
Time Frame: Median 4 years of follow-up (interim analysis planned)
|
IDFS is defined as the time from randomization (or first dose of study medication if in the non-randomized arm) 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 (STEEP version 2).
|
Median 4 years of follow-up (interim analysis planned)
|
|
Distant Disease-free Survival (DDFS)
Time Frame: Median 4 years of follow-up (interim analysis planned)
|
DDFS will be defined as the time from randomization (or the first dose of study medication if in the non-randomized arm) to the time of distant disease recurrence or death.
|
Median 4 years of follow-up (interim analysis planned)
|
|
Overall Survival
Time Frame: Median 4 years of follow-up (interim analysis planned)
|
Overall survival will be defined as the time from randomization (or the first dose of study medication if in the non-randomized arm) until death from any cause.
|
Median 4 years of follow-up (interim analysis planned)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Immune Response Measurements
Time Frame: DTH tests: Screening, Baseline, Month 4, Month 6, Month 12, Month 13, Month 18, Month 24, Month 25, Month 30, Month 36, Month 37, Month 42, Month 48. Injection site reactions are assessed at each administration.
|
Immune response will be measured by Delayed-Type Hypersensitivity (DTH) tests, injection site reactions and immunologic assays.
|
DTH tests: Screening, Baseline, Month 4, Month 6, Month 12, Month 13, Month 18, Month 24, Month 25, Month 30, Month 36, Month 37, Month 42, Month 48. Injection site reactions are assessed at each administration.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mothaffar F Rimawi, MD, Baylor College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 16, 2022
Primary Completion (Estimated)
December 1, 2031
Study Completion (Estimated)
December 1, 2031
Study Registration Dates
First Submitted
January 31, 2022
First Submitted That Met QC Criteria
January 31, 2022
First Posted (Actual)
February 10, 2022
Study Record Updates
Last Update Posted (Actual)
August 6, 2026
Last Update Submitted That Met QC Criteria
August 4, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLSI-21-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.