Clinical trial NCT05232916: Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
Official 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: HER2/neu positive
Residual disease
pCR
Extended adjuvant
GP2
Immunotherapy
HLA type
Lead sponsor: Greenwich LifeSciences, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-10
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HLA-A\*02 subjects will be randomized to GLSI-100 or placebo. 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.
Primary purpose: TREATMENT

Brief 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 criteria: 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 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.

Primary outcomes:
measure: Invasive Breast Cancer-free Survival (IBCFS)
timeFrame: Median 4 years of follow-up (interim analysis planned)
Secondary outcomes:
measure: Invasive Disease-free Survival (IDFS)
timeFrame: Median 4 years of follow-up (interim analysis planned)
measure: Distant Disease-free Survival (DDFS)
timeFrame: Median 4 years of follow-up (interim analysis planned)
measure: Overall Survival
timeFrame: Median 4 years of follow-up (interim analysis planned)
measure: Quality of Life Questionnaire Core 30 (QLQ-C30)
timeFrame: Baseline and 36 months
measure: Quality of Life FACT-GP5
timeFrame: Baseline and 36 months
Other outcomes:
measure: Immune Response Measurements
timeFrame: 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
Locations:
city: Tucson
country: United States
facility: Arizona Oncology Associates - Tucson
state: Arizona
city: Fullerton
country: United States
facility: Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center
state: California
city: La Jolla
country: United States
facility: University of California San Diego - Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California - Norris Comprehensive Cancer Center
state: California
city: Palo Alto
country: United States
facility: Stanford Medicine Cancer Center - Stanford Women's Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
state: California
city: Santa Monica
country: United States
facility: University of California Los Angeles - Hematology / Oncology Parkside
state: California
city: Whittier
country: United States
facility: PIH Health Hospital - Whittier Hospital
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center - Smilow Cancer Hospital
state: Connecticut
city: Washington
country: United States
facility: Johns Hopkins Medicine - Kimmel Cancer Center-Sibley Memorial Hospital
state: District of Columbia
city: Miami
country: United States
facility: University of Miami - Sylvester Comprehensive Cancer Center
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University - Northwestern Memorial Hospital
state: Illinois
city: Annapolis
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Maple Grove
country: United States
facility: Minnesota Oncology - Maple Grove Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Siteman Cancer Center - Washington University Medical Campus
state: Missouri
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Medicine - University of Nebraska Medical Center
state: Nebraska
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Camden
country: United States
facility: Cooper University Health Care
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Cancer Center
state: New York
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Tigard
country: United States
facility: Compass Oncology - Northwest Cancer Specialists
state: Oregon
city: Meadowbrook
country: United States
facility: Redeemer Health - Holy Redeemer Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center - Thomas Jefferson University Hospital
state: Pennsylvania
city: Austin
country: United States
facility: Texas Oncology - Austin
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Dallas Presbyterian Hospital
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center
state: Texas
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine - Dan L. Duncan Comprehensive Cancer Center
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Sciences Center at San Antonio - Mays Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio
state: Texas
city: Sugar Land
country: United States
facility: Texas Oncology - Gulf Coast
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah - Huntsman Cancer Institute
state: Utah
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Avignon
country: France
facility: Sainte-Catherine - Institut du Cancer Avignon-Provence (ICAP)
city: Beauvais
country: France
facility: Centre Hospitalier Simone Veil de Beauvais
city: Brest
country: France
facility: Clinique Pasteur-Lanroze
city: Caen
country: France
facility: Centre François Baclesse (CLCC)
city: Lyon
country: France
facility: Centre Léon Bérard
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Osny
country: France
facility: Centre Hospitalier Privé Sainte-Marie Osny
city: Paris
country: France
facility: Institut Curie
city: Pontoise
country: France
facility: Hôpital NOVO (Nord-Ouest Val-d'Oise)
city: Quimper
country: France
facility: Centre Hospitalier Intercommunal de Cornouaille Quimper Concarneau (CHIC)
city: Reims
country: France
facility: Institut Godinot (CLCC)
city: Saint-Cloud
country: France
facility: Institut Curie
city: Saint-Grégoire
country: France
facility: Centre Hospitalier Privé Saint-Grégoire
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Étienne
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe
city: Valence
country: France
facility: Hôpital privé Drôme Ardèche
city: Vantoux
country: France
facility: Hôpital Robert Schuman
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Augsburg
country: Germany
facility: Hämatololgisch Onkologische Praxis Heinrich Bangerter Augsburg
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth GmbH
city: Berlin
country: Germany
facility: DBZ Onkologie GmbH
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch
city: Bottrop
country: Germany
facility: Marienhospital Bottrop gGmbH
city: Bremen
country: Germany
facility: Evangelisches Diakonie-Krankenhaus Bremen
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Dessau
country: Germany
facility: Städtisches Klinikum Dessau
city: Dortmund
country: Germany
facility: St.-Johannes Hospital Dortmund
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Düsseldorf
country: Germany
facility: Zentrum für Gynäkologische Onkologie Düsseldorf
city: Eggenfelden
country: Germany
facility: Studienzentrale für das MVZ Eggenfelden e.K.
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
city: Frankfurt
country: Germany
facility: Klinikum Frankfurt Höchst GmbH
city: Freiburg
country: Germany
facility: Praxis für Interdisziplinäre Onkologie & Hämatologie
city: Gifhorn
country: Germany
facility: Helios Klinikum Gifhorn GmbH - Brustzentrum
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Halle
country: Germany
facility: Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
city: Hamburg-Harburg
country: Germany
facility: Gynäkologische Praxisklinik Hamburg-Harburg
city: Hamburg
country: Germany
facility: Mammazentrum Hamburg
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Kassel
country: Germany
facility: Elisabeth Krankenhaus Kassel
city: Krefeld
country: Germany
facility: MVZ GynKrefeld GmbH am Helios Klinikum Krefeld
city: Langen
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie Langen
city: Leer
country: Germany
facility: Studienzentrum UnterEms Leer
city: Ludwigsburg
country: Germany
facility: RKH Klinikum Ludwigsburg
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz
city: Mannheim
country: Germany
facility: Universitätsfrauenklinik Mannheim
city: Munich
country: Germany
facility: München Klinik gGmbH
city: Munich
country: Germany
facility: TUM München
city: Rostock
country: Germany
facility: Klinikum Südstadt, Universitätsfrauenklinik
city: Rüsselsheim
country: Germany
facility: GPR Klinikum Rüsselsheim
city: Speyer
country: Germany
facility: Diakonissen-Stiftungs-Krankenhaus Speyer
city: Trier
country: Germany
facility: Klinikum Mutterhaus der Borromäerinnen gGmbH
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm AöR
city: Witten
country: Germany
facility: Marienhospital Witten
city: Worms
country: Germany
facility: Klinikum Worms - Frauenklinik
city: Wuppertal
country: Germany
facility: Helios Universitätsklinikum Wuppertal
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
city: Milan
country: Italy
facility: Humanitas Research Hospital
city: Naples
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II Di Napoli
city: Naples
country: Italy
facility: Istituto Nazionale Tumori Fondazione Pascale IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri Spa Società Benefit IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
city: Konin
country: Poland
facility: Przychodnia Lekarska KOMED Roman Karaszewski
city: Kraków
country: Poland
facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej (ZOZ) Szpital Uniwersytecki w Krakowie
city: Kraków
country: Poland
facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
city: Opole
country: Poland
facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej (SPOZOZ) Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
city: Poznań
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu
city: Rzeszów
country: Poland
facility: Centrum Medyczne MrukMed
city: Słupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku
city: Warsaw
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie
city: Warsaw
country: Poland
facility: Wojskowy Instytut Medyczny, Państwowy Instytut Badawczy
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario de Albacete
city: Alicante
country: Spain
facility: Hospital General Universitario Dr. Balmis
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
city: Barcelona
country: Spain
facility: Hospital Clínic De Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: El Palmar
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo
city: Granada
country: Spain
facility: Hospital Universitario Clínico San Cecilio
city: Jaén
country: Spain
facility: Hospital Universitario de Jaén
city: Jerez De La Frontera
country: Spain
facility: Hospital Universitario de Jerez de la Frontera
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova (Lleida)
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Manresa
country: Spain
facility: Althaia, Xarxa Assistencial Universitària de Manresa
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
city: Málaga
country: Spain
facility: Hospital Clínico Universitario Virgen de la Victoria
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Espases
city: San Juan De Alicante
country: Spain
facility: Hospital Universitario San Juan de Alicante
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
city: Sant Cugat Del Vallès
country: Spain
facility: Hospital Universitari General de Catalunya - Grupo Quirónsalud
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Toledo
country: Spain
facility: Hospital Universitario de Toledo
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari Arnau de Vilanova (Valencia)
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Baylor College of Medicine
name: Mothaffar F Rimawi, MD
role: PRINCIPAL_INVESTIGATOR
References: