Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects

PHASE3RecruitingINTERVENTIONAL
Enrollment

750

Participants

Timeline

Start Date

August 11, 2022

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Breast Cancer
Interventions
BIOLOGICAL

Placebo

0.9% Normal Saline

BIOLOGICAL

GLSI-100

500 mcg/mL GP2 and 125 mcg/mL GM-CSF

Trial Locations (161)

10032

RECRUITING

New York-Presbyterian - Columbia University Irving Medical Center, New York

11794

RECRUITING

Stony Brook University Cancer Center, Stony Brook

12065

RECRUITING

New York Oncology Hematology, Albany

19046

RECRUITING

Redeemer Health - Holy Redeemer Hospital, Meadowbrook

19107

RECRUITING

Sidney Kimmel Comprehensive Cancer Center - Thomas Jefferson University Hospital, Philadelphia

20016

RECRUITING

Johns Hopkins Medicine - Kimmel Cancer Center-Sibley Memorial Hospital, Washington D.C.

21401

RECRUITING

Maryland Oncology Hematology, Annapolis

22031

RECRUITING

Virginia Cancer Specialists, Fairfax

33146

RECRUITING

University of Miami - Sylvester Comprehensive Cancer Center, Miami

33612

RECRUITING

Moffitt Cancer Center, Tampa

45211

RECRUITING

Oncology Hematology Care, Cincinnati

55369

RECRUITING

Minnesota Oncology, Maple Grove

60611

RECRUITING

Northwestern University - Northwestern Memorial Hospital, Chicago

63110

RECRUITING

Siteman Cancer Center - Washington University Medical Campus, St Louis

68114

RECRUITING

Nebraska Cancer Specialists, Omaha

68198

RECRUITING

Nebraska Medicine - University of Nebraska Medical Center, Omaha

74304

RECRUITING

Stanford Medicine Cancer Center - Stanford Women's Cancer Center, Palo Alto

75231

RECRUITING

Texas Oncology - Dallas Presbyterian Hospital, Dallas

75246

RECRUITING

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas

75390

RECRUITING

The University of Texas Southwestern Medical Center, Dallas

75702

RECRUITING

Texas Oncology - Tyler, Tyler

77057

RECRUITING

Baylor College of Medicine - Dan L. Duncan Comprehensive Cancer Center, Houston

77479

RECRUITING

Texas Oncology - Gulf Coast, Sugar Land

78229

RECRUITING

The University of Texas Health Sciences Center at San Antonio - Mays Cancer Center, San Antonio

78240

RECRUITING

Texas Oncology - San Antonio, San Antonio

78745

RECRUITING

Texas Oncology - Austin, Austin

80220

RECRUITING

Rocky Mountain Cancer Centers, Denver

84112

RECRUITING

University of Utah - Huntsman Cancer Institute, Salt Lake City

85704

RECRUITING

Tucson Medical Center HealthCare - Tucson-Rudasill, Tucson

89052

RECRUITING

Comprehensive Cancer Centers of Nevada, Henderson

90033

ACTIVE_NOT_RECRUITING

University of Southern California - Norris Comprehensive Cancer Center, Los Angeles

90404

RECRUITING

University of California Los Angeles - Hematology / Oncology Parkside, Santa Monica

90602

RECRUITING

PIH Health Hospital - Whittier Hospital, Whittier

92093

RECRUITING

University of California San Diego - Moores Cancer Center, La Jolla

92835

RECRUITING

Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center, Fullerton

94158

RECRUITING

University of California San Francisco - Helen Diller Family Comprehensive Cancer Center, San Francisco

97223

RECRUITING

Compass Oncology - Northwest Cancer Specialists, Tigard

06511

RECRUITING

Yale Cancer Center - Smilow Cancer Hospital, New Haven

02114

RECRUITING

Massachusetts General Hospital Cancer Center, Boston

08103

RECRUITING

Cooper University Health Care, Camden

Unknown

RECRUITING

Sainte-Catherine - Institut du Cancer Avignon-Provence (ICAP), Avignon

RECRUITING

Clinique Pasteur-Lanroze, Brest

RECRUITING

Centre François Baclesse (CLCC), Caen

NOT_YET_RECRUITING

Pôle Santé Léonard De Vinci, Chambray-lès-Tours

NOT_YET_RECRUITING

Centre Hospitalier de Cholet, Cholet

NOT_YET_RECRUITING

Centre Hospitalier Alpes Leman, Contamine-sur-Arve

RECRUITING

Centre Léon Bérard, Lyon

NOT_YET_RECRUITING

Hôpital Privé du Confluent, Nantes

RECRUITING

Centre Hospitalier Privé Sainte-Marie Osny, Osny

RECRUITING

Institut Curie, Paris

NOT_YET_RECRUITING

Hospices Civils de Lyon, Pierre-Bénite

RECRUITING

Hôpital NOVO (Nord-Ouest Val-d'Oise), Pontoise

RECRUITING

Institut Jean Godinot (CLCC), Reims

RECRUITING

Institut Curie, Saint-Cloud

RECRUITING

Centre Hospitalier Privé Saint-Grégoire, Saint-Grégoire

RECRUITING

Centre Hospitalier Universitaire de Saint-Étienne, Saint-Priest-en-Jarez

RECRUITING

Institut de cancérologie Strasbourg Europe, Strasbourg

RECRUITING

Hôpital Privé Drôme Ardèche, Valence

RECRUITING

Hôpital Robert Schuman, Vantoux

RECRUITING

Institut Gustave Roussy, Villejuif

RECRUITING

Haematologie-Onkologie im Zentrum MVZ GmbH, Augsburg

NOT_YET_RECRUITING

Klinikum Bayreuth GmbH, Bayreuth

NOT_YET_RECRUITING

DBZ Onkologie GmbH, Berlin

RECRUITING

Helios Klinikum Berlin-Buch GmbH, Berlin

RECRUITING

Marienhospital Bottrop gGmbH, Bottrop

RECRUITING

Evangelisches Diakonie-Krankenhaus gGmbH, Bremen

NOT_YET_RECRUITING

Klinikum Chemnitz gGmbH, Chemnitz

RECRUITING

Städtisches Klinikum Dessau, Dessau

ACTIVE_NOT_RECRUITING

St.-Johannes Hospital Dortmund, Dortmund

NOT_YET_RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR, Dresden

RECRUITING

MVZ Medical Center Duesseldorf GmbH, Düsseldorf

RECRUITING

Studienzentrale für das MVZ Eggenfelden e.K., Eggenfelden

RECRUITING

Evangelisches Kliniken Essen-Mitte gGmbH, Essen

RECRUITING

Klinikum Frankfurt Höchst GmbH, Frankfurt

RECRUITING

Praxis für Interdisziplinäre Onkologie und Haematologie GbR, Freiburg im Breisgau

RECRUITING

Helios Klinikum Gifhorn GmbH, Gifhorn

NOT_YET_RECRUITING

Universitätsmedizin Göttingen, Göttingen

RECRUITING

Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH, Halle

RECRUITING

Mammazentrum Hamburg MVZ GbR, Hamburg

RECRUITING

Gynäkologische Praxisklinik Hamburg-Harburg, Harburg

RECRUITING

National Center For Tumor Diseases (NCT) Heidelberg, Heidelberg

RECRUITING

Elisabeth Krankenhaus GmbH, Kassel

NOT_YET_RECRUITING

MVZ GynKrefeld GmbH, Krefeld

ACTIVE_NOT_RECRUITING

Gemeinschaftspraxis für Hämatologie und Onkologie Langen, Langen

ACTIVE_NOT_RECRUITING

Studienzentrum UnterEms Leer, Leer

RECRUITING

RKH Klinken Ludwigsburg-Bietigheim gGmbH, Ludwigsburg

NOT_YET_RECRUITING

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Mainz

NOT_YET_RECRUITING

Heidelberg University, Mannheim

NOT_YET_RECRUITING

Klinikum der Technischen Universitaet Muenchen (TUM Klinikum), Munich

NOT_YET_RECRUITING

München Klinik gGmbH, Munich

RECRUITING

Klinikum Südstadt Rostock Eigenbetrieb der Hanse und Universitätsstadt Rostock, Rostock

RECRUITING

Gesundheits und Pflegezentrum Ruesselsheim gGmbH, Rüsselsheim am Main

ACTIVE_NOT_RECRUITING

Diakonissen-Stiftungs-Krankenhaus Speyer, Speyer

NOT_YET_RECRUITING

Klinikum Mutterhaus der Borromäerinnen gGmbH, Trier

NOT_YET_RECRUITING

Universitätsklinikum Ulm AöR, Ulm

RECRUITING

Marienhospital Witten, Witten

RECRUITING

Klinikum Worms gGmbH, Worms

RECRUITING

Helios Universitätsklinikum Wuppertal, Wuppertal

NOT_YET_RECRUITING

St. Vincent's University Hospital, Dublin

RECRUITING

Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico), Bologna

RECRUITING

Ospedale Policlinico San Martino IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico), Genova

RECRUITING

Humanitas Research Hospital, Milan

RECRUITING

Azienda Ospedaliera Universitaria Federico II Di Napoli, Naples

RECRUITING

Istituto Nazionale Tumori Fondazione Pascale IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico), Naples

RECRUITING

Azienda Ospedaliero Universitaria Maggiore della Carità di Novara, Novara

RECRUITING

Istituto Oncologico Veneto, Padua

RECRUITING

Istituti Clinici Scientifici Maugeri Spa Società Benefit IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico), Pavia

RECRUITING

Azienda Ospedaliero Universitaria Pisana, Pisa

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico), Rome

RECRUITING

Przychodnia Lekarska KOMED Roman Karaszewski, Konin

RECRUITING

Samodzielny Publiczny Zakład Opieki Zdrowotnej (ZOZ) Szpital Uniwersytecki w Krakowie, Krakow

RECRUITING

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Krakow

RECRUITING

Samodzielny Publiczny Zakład Opieki Zdrowotnej (SPOZOZ) Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu, Opole

RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan

RECRUITING

Centrum Medyczne MrukMed, Rzeszów

RECRUITING

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku, Słupsk

NOT_YET_RECRUITING

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie, Warsaw

RECRUITING

Wojskowy Instytut Medyczny, Państwowy Instytut Badawczy, Warsaw

RECRUITING

Filantropia Clinical Hospital, Bucharest

RECRUITING

Neolife Baneasa Bucharest Medical Center, Bucharest

RECRUITING

"Institute of Oncology Prof Dr Ion Chiricuta", Cluj-Napoca

RECRUITING

Oncomed SRL - Oncology Center, Timișoara

RECRUITING

Complejo Hospitalario Universitario de Albacete, Albacete

RECRUITING

Hospital General Universitario Dr. Balmis, Alicante

RECRUITING

Hospital Universitario de Badajoz, Badajoz

RECRUITING

Hospital Clínic De Barcelona, Barcelona

RECRUITING

Hospital del Mar, Barcelona

RECRUITING

Hospital San Pedro de Alcántara, Cáceres

RECRUITING

Hospital Universitario Reina Sofía, Córdoba

RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar

RECRUITING

Hospital Universitario de Fuenlabrada, Fuenlabrada

RECRUITING

Hospital Galdakao-Usansolo, Galdakao

RECRUITING

Hospital Universitario Clínico San Cecilio, Granada

RECRUITING

Hospital Universitario de Jaén, Jaén

RECRUITING

Hospital Universitario de Jerez de la Frontera, Jerez de la Frontera

RECRUITING

Hospital Universitari Arnau de Vilanova (Lleida), Lleida

RECRUITING

Hospital General Universitario Gregorio Marañón, Madrid

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

RECRUITING

Hospital Universitario Fundación Jiménez Díaz, Madrid

RECRUITING

Hospital Universitario HM Sanchinarro, Madrid

NOT_YET_RECRUITING

Hospital Universitario Infanta Leonor, Madrid

RECRUITING

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

RECRUITING

Althaia, Xarxa Assistencial Universitària de Manresa, Manresa

RECRUITING

Hospital Clínico Universitario Virgen de la Victoria, Málaga

RECRUITING

Hospital Regional Universitario de Malaga, Málaga

RECRUITING

Hospital General Universitario Morales Meseguer, Murcia

RECRUITING

Hospital Universitari Son Espases, Palma de Mallorca

RECRUITING

Hospital Universitario de Canarias, San Cristóbal de La Laguna

RECRUITING

Hospital Universitario Donostia, San Sebastián

RECRUITING

Hospital Universitari General de Catalunya - Grupo Quirónsalud, Sant Cugat del Vallès

RECRUITING

Hospital Universitario San Juan de Alicante, Sant Joan d'Alacant

NOT_YET_RECRUITING

Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife

RECRUITING

Hospital Clínico Universitario de Santiago, Santiago de Compostela

RECRUITING

Hospital Universitario Virgen del Rocío, Seville

RECRUITING

Hospital Universitario Virgen Macarena, Seville

RECRUITING

Hospital Universitario de Toledo, Toledo

RECRUITING

Consorcio Hospital General Universitario de Valencia, Valencia

RECRUITING

Hospital Clínico Universitario de Valencia, Valencia

NOT_YET_RECRUITING

Hospital Universitari Arnau de Vilanova (Valencia), Valencia

RECRUITING

Hospital Clínico Universitario Lozano Blesa, Zaragoza

RECRUITING

Hospital Universitario Miguel Servet, Zaragoza

Sponsors
All Listed Sponsors
lead

Greenwich LifeSciences, Inc.

INDUSTRY