Clinical trial NCT04854499: Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
Official title: A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2021-04-22
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of the study drug, magrolimab in combination with other anticancer therapies in patients with head and neck squamous cell carcinoma (HNSCC).


Eligibility criteria: Key Inclusion Criteria:

* Histologically or cytologically confirmed metastatic or locally recurrent HNSCC that is considered incurable by local therapies.

Safety Run-in Cohort 1 and Phase 2 Cohorts 1

* Should not have had prior systemic therapy administered in the recurrent or metastatic setting.
* Eligible primary tumor locations include oropharynx, oral cavity, hypopharynx, and larynx. Nasopharynx is not included.
* HNSCC per protocol specified inclusion criteria regardless of PD-L1 status.

Safety Run-in Cohort 2 and Phase 2 Cohort 3

* Histologically or cytologically confirmed locally advanced/mHNSCC regardless of PD-L1 status with at least 1 and no more than 2 lines of prior systemic anticancer therapy in the locally advanced/metastatic setting.

Key Exclusion Criteria:

* Active central nervous system (CNS) disease (individuals with asymptomatic and stable, treated CNS lesions who have been off corticosteroids, radiation, or other CNS-directed therapy for at least 4 weeks are not considered active).
* History of (noninfectious) pneumonitis that required steroids or current pneumonitis.
* Progressive disease within 6 months of completion of curatively intended treatment for locally advanced/mHNSCC.

Safety Run-in Cohort 1, Pre-expansion Safety Run-in Cohort for Magrolimab + Pembrolizumab (if Applicable), and Phase 2 Cohorts 1 and 2

* Prior treatment with any of the following:

  * Anti-programmed cell death protein 1 or anti-PD-L1 checkpoint inhibitors.
  * Anti-cytotoxic T-lymphocyte-associated protein 4 checkpoint inhibitors.

Safety Run-in Cohort 2 and Phase 2 Cohort 3

* Prior treatment with a taxane.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Safety Run-in Cohorts: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
timeFrame: First Dose up to 21 days
measure: Phase 2 Cohorts 1: Progression-free Survival (PFS)
timeFrame: Up to 5 years
measure: Phase 2 Cohorts 2 and 3: Objective Response Rate (ORR)
timeFrame: Up to 9 months
Secondary outcomes:
measure: Safety Run-In and Phase 2 Cohorts: Serum Concentration of Magrolimab
timeFrame: Up to end of treatment (approximately 24 months)
measure: Safety Run-In and Phase 2 Cohorts: Percentage of Participants who Developed Antidrug Antibodies (ADAs) to Magrolimab
timeFrame: Up to end of treatment (approximately 24 months)
measure: Phase 2 Cohorts: Objective Response Rate (ORR)
timeFrame: Up to 9 months
measure: Phase 2 Cohorts: Progression-free Survival (PFS)
timeFrame: Up to 5 years
measure: Phase 2 Cohorts: Duration of Response (DOR)
timeFrame: Up to 5 years
measure: Phase 2 Cohorts: Overall Survival (OS)
timeFrame: Up to 5 years
measure: Phase 2 Cohorts: Change from Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score
timeFrame: Baseline; up to 24 months
measure: Phase 2 Cohorts: Change from Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35)
timeFrame: Baseline; up to 24 months
measure: Phase 2 Cohorts: Change From Baseline in the 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L)
timeFrame: Baseline; up to 24 months
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer and Research Center
state: Arizona
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Institute
state: California
city: Redondo Beach
country: United States
facility: Torrance Memorial Physician Network - Cancer Care Associates
state: California
city: Santa Rosa
country: United States
facility: Providence Medical Foundation
state: California
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Athens
country: United States
facility: University Center and Blood Center,LLC.
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Center (Alliant Health
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University of Medicine- Siteman Cancer Center
state: Missouri
city: East Brunswick
country: United States
facility: Astera Cancer Care
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai and the Mount Sinai Hospital
state: New York
city: Port Jefferson Station
country: United States
facility: New York Cancer and Blood Specialists
state: New York
city: Fargo
country: United States
facility: Sanford Roger Maris Cancer Center
state: North Dakota
city: Oklahoma City
country: United States
facility: OU Health Stephenson Cancer Center
state: Oklahoma
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital Sydney
state: New South Wales
city: Macquarie Park
country: Australia
facility: Macquarie University
state: New South Wales
city: Westmead
country: Australia
facility: Blacktown Hospital
state: New South Wales
city: Cairns
country: Australia
facility: Cairns Hospital
state: Queensland
city: Sippy Downs
country: Australia
facility: University of the Sunshine Coast
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
city: Antwerpen
country: Belgium
facility: ZiekenhuisNetwerk Antwerpen (ZNA) - Stuivenberg
city: Brasschaat
country: Belgium
facility: Algemeen Ziekenhuis Klina
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuis Leuven
city: Libramont-Chevigny
country: Belgium
facility: Centre Hospitalizer De L'Ardenne
city: Mechelen
country: Belgium
facility: AZ Sint-Maarten
city: Namur
country: Belgium
facility: CHU UCL Namur - Sainte-Elisabeth
city: Bordeaux
country: France
facility: Institut Bergonie
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Hopital de la Timone
city: Nice
country: France
facility: Centre de Lutte Contre le Cancer (CLCC) - Centre Antoine Lacassagne (CAL) - Site Est
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hopital Pitie-Salpetriere
city: Pierre-benite
country: France
facility: Civils de Lyon-Centre Hopitalier Lyon Sud
city: Suresnes
country: France
facility: Hopital Foch
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Charite University Medicine
city: Bonn
country: Germany
facility: UniversitÃ¤tsklinikum Bonn, Medizinische Klinik und Poliklinik III
city: GÃttingen
country: Germany
facility: Universitatsmedizin Gottingen
city: Hamburg
country: Germany
facility: Kath. Marienkrankenhaus gGmbH
city: Leipzig
country: Germany
facility: Universitäres Krebszentrum Leipzig
city: Munich
country: Germany
facility: Technische Universitat Munchen (TUM) - Klinikum Rechts der Isar
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Lai Chi Kok
country: Hong Kong
facility: Princess Margaret Hospital
city: Bologna
country: Italy
facility: Azienda Ospedaliero - Universitaria di Bologna - IRCCS
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia
city: Lucca
country: Italy
facility: Ospedale San Luca Luca
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Tumori Milano
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena - Policlinico
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Siena
country: Italy
facility: Azienda Ospedaliero - Universitaria Senese
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie, Panstwowy Instytut Badawczy, Oddzial x Gliwicach
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie, Oddzial Onkologii Klinicznej i Immunookologii z Poddoddzialem Dziennym i Izba Przyjec
city: Siedlce
country: Poland
facility: Wojewodzki Szpital Specjalistyczny w Siedlcach
city: Warsaw
country: Poland
facility: Narodowy Instytut Onkologii im. M. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Glowy i Szyi
city: Braga
country: Portugal
facility: Hospital de Braga
city: Faro
country: Portugal
facility: Centro Hospitalar do Algarve
city: Lisboa
country: Portugal
facility: Hospital CUF Descobertas
city: Matosinhos
country: Portugal
facility: Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario do Porto
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil,E.P.E.
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital De La Santa Creu I Sant Pau
city: Jaen
country: Spain
facility: Hospital Universitario de Jaen
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust, Royal Marsden - Sutton
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: