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)

Status: Recruiting
Location: See all (161) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
Tucson Medical Center HealthCare - Tucson-Rudasill
RECRUITING
Tucson
California
Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center
RECRUITING
Fullerton
University of California San Diego - Moores Cancer Center
RECRUITING
La Jolla
University of Southern California - Norris Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING
Los Angeles
Stanford Medicine Cancer Center - Stanford Women's Cancer Center
RECRUITING
Palo Alto
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
RECRUITING
San Francisco
University of California Los Angeles - Hematology / Oncology Parkside
RECRUITING
Santa Monica
PIH Health Hospital - Whittier Hospital
RECRUITING
Whittier
Colorado
Rocky Mountain Cancer Centers
RECRUITING
Denver
Connecticut
Yale Cancer Center - Smilow Cancer Hospital
RECRUITING
New Haven
Washington, D.c.
Johns Hopkins Medicine - Kimmel Cancer Center-Sibley Memorial Hospital
RECRUITING
Washington D.c.
Florida
University of Miami - Sylvester Comprehensive Cancer Center
RECRUITING
Miami
Moffitt Cancer Center
RECRUITING
Tampa
Illinois
Northwestern University - Northwestern Memorial Hospital
RECRUITING
Chicago
Massachusetts
Massachusetts General Hospital Cancer Center
RECRUITING
Boston
Maryland
Maryland Oncology Hematology
RECRUITING
Annapolis
Minnesota
Minnesota Oncology
RECRUITING
Maple Grove
Missouri
Siteman Cancer Center - Washington University Medical Campus
RECRUITING
St Louis
Nebraska
Nebraska Cancer Specialists
RECRUITING
Omaha
Nebraska Medicine - University of Nebraska Medical Center
RECRUITING
Omaha
New Jersey
Cooper University Health Care
RECRUITING
Camden
Nevada
Comprehensive Cancer Centers of Nevada
RECRUITING
Henderson
New York
New York Oncology Hematology
RECRUITING
Albany
New York-Presbyterian - Columbia University Irving Medical Center
RECRUITING
New York
Stony Brook University Cancer Center
RECRUITING
Stony Brook
Ohio
Oncology Hematology Care
RECRUITING
Cincinnati
Oregon
Compass Oncology - Northwest Cancer Specialists
RECRUITING
Tigard
Pennsylvania
Redeemer Health - Holy Redeemer Hospital
RECRUITING
Meadowbrook
Sidney Kimmel Comprehensive Cancer Center - Thomas Jefferson University Hospital
RECRUITING
Philadelphia
Texas
Texas Oncology - Austin
RECRUITING
Austin
Texas Oncology - Baylor Charles A. Sammons Cancer Center
RECRUITING
Dallas
Texas Oncology - Dallas Presbyterian Hospital
RECRUITING
Dallas
The University of Texas Southwestern Medical Center
RECRUITING
Dallas
Baylor College of Medicine - Dan L. Duncan Comprehensive Cancer Center
RECRUITING
Houston
Texas Oncology - San Antonio
RECRUITING
San Antonio
The University of Texas Health Sciences Center at San Antonio - Mays Cancer Center
RECRUITING
San Antonio
Texas Oncology - Gulf Coast
RECRUITING
Sugar Land
Texas Oncology - Tyler
RECRUITING
Tyler
Utah
University of Utah - Huntsman Cancer Institute
RECRUITING
Salt Lake City
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Other Locations
France
Sainte-Catherine - Institut du Cancer Avignon-Provence (ICAP)
RECRUITING
Avignon
Clinique Pasteur-Lanroze
RECRUITING
Brest
Centre François Baclesse (CLCC)
RECRUITING
Caen
Pôle Santé Léonard De Vinci
NOT_YET_RECRUITING
Chambray-lès-tours
Centre Hospitalier de Cholet
NOT_YET_RECRUITING
Cholet
Centre Hospitalier Alpes Leman
NOT_YET_RECRUITING
Contamine-sur-arve
Centre Léon Bérard
RECRUITING
Lyon
Hôpital Privé du Confluent
NOT_YET_RECRUITING
Nantes
Centre Hospitalier Privé Sainte-Marie Osny
RECRUITING
Osny
Institut Curie
RECRUITING
Paris
Hospices Civils de Lyon
NOT_YET_RECRUITING
Pierre-bénite
Hôpital NOVO (Nord-Ouest Val-d'Oise)
RECRUITING
Pontoise
Institut Jean Godinot (CLCC)
RECRUITING
Reims
Institut Curie
RECRUITING
Saint-cloud
Centre Hospitalier Privé Saint-Grégoire
RECRUITING
Saint-grégoire
Centre Hospitalier Universitaire de Saint-Étienne
RECRUITING
Saint-priest-en-jarez
Institut de cancérologie Strasbourg Europe
RECRUITING
Strasbourg
Hôpital Privé Drôme Ardèche
RECRUITING
Valence
Hôpital Robert Schuman
RECRUITING
Vantoux
Institut Gustave Roussy
RECRUITING
Villejuif
Germany
Haematologie-Onkologie im Zentrum MVZ GmbH
RECRUITING
Augsburg
Klinikum Bayreuth GmbH
NOT_YET_RECRUITING
Bayreuth
DBZ Onkologie GmbH
NOT_YET_RECRUITING
Berlin
Helios Klinikum Berlin-Buch GmbH
RECRUITING
Berlin
Marienhospital Bottrop gGmbH
RECRUITING
Bottrop
Evangelisches Diakonie-Krankenhaus gGmbH
RECRUITING
Bremen
Klinikum Chemnitz gGmbH
NOT_YET_RECRUITING
Chemnitz
Städtisches Klinikum Dessau
RECRUITING
Dessau
St.-Johannes Hospital Dortmund
ACTIVE_NOT_RECRUITING
Dortmund
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
NOT_YET_RECRUITING
Dresden
MVZ Medical Center Duesseldorf GmbH
RECRUITING
Düsseldorf
Studienzentrale für das MVZ Eggenfelden e.K.
RECRUITING
Eggenfelden
Evangelisches Kliniken Essen-Mitte gGmbH
RECRUITING
Essen
Klinikum Frankfurt Höchst GmbH
RECRUITING
Frankfurt
Praxis für Interdisziplinäre Onkologie und Haematologie GbR
RECRUITING
Freiburg Im Breisgau
Helios Klinikum Gifhorn GmbH
RECRUITING
Gifhorn
Universitätsmedizin Göttingen
NOT_YET_RECRUITING
Göttingen
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
RECRUITING
Halle
Mammazentrum Hamburg MVZ GbR
RECRUITING
Hamburg
Gynäkologische Praxisklinik Hamburg-Harburg
RECRUITING
Harburg
National Center For Tumor Diseases (NCT) Heidelberg
RECRUITING
Heidelberg
Elisabeth Krankenhaus GmbH
RECRUITING
Kassel
MVZ GynKrefeld GmbH
NOT_YET_RECRUITING
Krefeld
Gemeinschaftspraxis für Hämatologie und Onkologie Langen
ACTIVE_NOT_RECRUITING
Langen
Studienzentrum UnterEms Leer
ACTIVE_NOT_RECRUITING
Leer
RKH Klinken Ludwigsburg-Bietigheim gGmbH
RECRUITING
Ludwigsburg
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
NOT_YET_RECRUITING
Mainz
Heidelberg University
NOT_YET_RECRUITING
Mannheim
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
NOT_YET_RECRUITING
Munich
München Klinik gGmbH
NOT_YET_RECRUITING
Munich
Klinikum Südstadt Rostock Eigenbetrieb der Hanse und Universitätsstadt Rostock
RECRUITING
Rostock
Gesundheits und Pflegezentrum Ruesselsheim gGmbH
RECRUITING
Rüsselsheim Am Main
Diakonissen-Stiftungs-Krankenhaus Speyer
ACTIVE_NOT_RECRUITING
Speyer
Klinikum Mutterhaus der Borromäerinnen gGmbH
NOT_YET_RECRUITING
Trier
Universitätsklinikum Ulm AöR
NOT_YET_RECRUITING
Ulm
Marienhospital Witten
RECRUITING
Witten
Klinikum Worms gGmbH
RECRUITING
Worms
Helios Universitätsklinikum Wuppertal
RECRUITING
Wuppertal
Ireland
St. Vincent's University Hospital
NOT_YET_RECRUITING
Dublin
Italy
Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
RECRUITING
Bologna
Ospedale Policlinico San Martino IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
RECRUITING
Genova
Humanitas Research Hospital
RECRUITING
Milan
Azienda Ospedaliera Universitaria Federico II Di Napoli
RECRUITING
Naples
Istituto Nazionale Tumori Fondazione Pascale IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
RECRUITING
Naples
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
RECRUITING
Novara
Istituto Oncologico Veneto
RECRUITING
Padua
Istituti Clinici Scientifici Maugeri Spa Società Benefit IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
RECRUITING
Pavia
Azienda Ospedaliero Universitaria Pisana
RECRUITING
Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
RECRUITING
Rome
Poland
Przychodnia Lekarska KOMED Roman Karaszewski
RECRUITING
Konin
Samodzielny Publiczny Zakład Opieki Zdrowotnej (ZOZ) Szpital Uniwersytecki w Krakowie
RECRUITING
Krakow
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
RECRUITING
Krakow
Samodzielny Publiczny Zakład Opieki Zdrowotnej (SPOZOZ) Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
RECRUITING
Opole
Uniwersytecki Szpital Kliniczny w Poznaniu
RECRUITING
Poznan
Centrum Medyczne MrukMed
RECRUITING
Rzeszów
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku
RECRUITING
Słupsk
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie
NOT_YET_RECRUITING
Warsaw
Wojskowy Instytut Medyczny, Państwowy Instytut Badawczy
RECRUITING
Warsaw
Romania
Filantropia Clinical Hospital
RECRUITING
Bucharest
Neolife Baneasa Bucharest Medical Center
RECRUITING
Bucharest
Institute of Oncology Prof Dr Ion Chiricuta
RECRUITING
Cluj-napoca
Oncomed SRL - Oncology Center
RECRUITING
Timișoara
Spain
Complejo Hospitalario Universitario de Albacete
RECRUITING
Albacete
Hospital General Universitario Dr. Balmis
RECRUITING
Alicante
Hospital Universitario de Badajoz
RECRUITING
Badajoz
Hospital Clínic De Barcelona
RECRUITING
Barcelona
Hospital del Mar
RECRUITING
Barcelona
Hospital San Pedro de Alcántara
RECRUITING
Cáceres
Hospital Universitario Reina Sofía
RECRUITING
Córdoba
Hospital Clínico Universitario Virgen de la Arrixaca
RECRUITING
El Palmar
Hospital Universitario de Fuenlabrada
RECRUITING
Fuenlabrada
Hospital Galdakao-Usansolo
RECRUITING
Galdakao
Hospital Universitario Clínico San Cecilio
RECRUITING
Granada
Hospital Universitario de Jaén
RECRUITING
Jaén
Hospital Universitario de Jerez de la Frontera
RECRUITING
Jerez De La Frontera
Hospital Universitari Arnau de Vilanova (Lleida)
RECRUITING
Lleida
Hospital General Universitario Gregorio Marañón
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro
RECRUITING
Madrid
Hospital Universitario Infanta Leonor
NOT_YET_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
RECRUITING
Majadahonda
Hospital Clínico Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital Regional Universitario de Malaga
RECRUITING
Málaga
Althaia, Xarxa Assistencial Universitària de Manresa
RECRUITING
Manresa
Hospital General Universitario Morales Meseguer
RECRUITING
Murcia
Hospital Universitari Son Espases
RECRUITING
Palma De Mallorca
Hospital Universitario de Canarias
RECRUITING
San Cristóbal De La Laguna
Hospital Universitario Donostia
RECRUITING
San Sebastián
Hospital Universitari General de Catalunya - Grupo Quirónsalud
RECRUITING
Sant Cugat Del Vallès
Hospital Universitario San Juan de Alicante
RECRUITING
Sant Joan D'alacant
Hospital Universitario Nuestra Señora de Candelaria
NOT_YET_RECRUITING
Santa Cruz De Tenerife
Hospital Clínico Universitario de Santiago
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Universitario de Toledo
RECRUITING
Toledo
Consorcio Hospital General Universitario de Valencia
RECRUITING
Valencia
Hospital Clínico Universitario de Valencia
RECRUITING
Valencia
Hospital Universitari Arnau de Vilanova (Valencia)
NOT_YET_RECRUITING
Valencia
Hospital Clínico Universitario Lozano Blesa
RECRUITING
Zaragoza
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Contact Information
Primary
Jaye L Thompson, Ph.D.
Jaye.Thompson@GreenwichLifeSciences.com
(832) 791-2542
Time Frame
Start Date: 2022-08-11
Estimated Completion Date: 2026-12
Participants
Target number of participants: 750
Treatments
Placebo_comparator: 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)
Experimental: 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)
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)
Related Therapeutic Areas
Sponsors
Leads: Greenwich LifeSciences, Inc.

This content was sourced from clinicaltrials.gov

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