Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

Head and Neck Squamous Cell Carcinoma Clinical Trial

— ELEVATE HNSCC  

Official title:

A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04854499
• Other study ID #: GS-US-548-5916
• Secondary ID: 2020-005708-20
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 7, 2021
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 230
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• Magrolimab
Administered intravenously
• Pembrolizumab
Administered intravenously
• Docetaxel
Administered intravenously
• 5-FU
Administered intravenously
• Cisplatin
Administered intravenously
• Carboplatin
Administered intravenously
• Zimberelimab
Administered intravenously

Locations

Country	Name	City	State
Australia	Cairns Hospital	Cairns	Queensland
Australia	St. Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	Austin Health	Heidelberg	Victoria
Australia	Macquarie University	Macquarie Park	New South Wales
Australia	Alfred Health	Melbourne	Victoria
Australia	University of the Sunshine Coast	Sippy Downs	Queensland
Australia	Blacktown Hospital	Westmead	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Belgium	ZiekenhuisNetwerk Antwerpen (ZNA) - Stuivenberg	Antwerpen
Belgium	Algemeen Ziekenhuis Klina	Brasschaat
Belgium	UZ Antwerpen	Edegem
Belgium	Universitaire Ziekenhuis Leuven	Leuven
Belgium	Centre Hospitalizer De L'Ardenne	Libramont-Chevigny
Belgium	AZ Sint-Maarten	Mechelen
Belgium	CHU UCL Namur - Sainte-Elisabeth	Namur
France	Institut Bergonie	Bordeaux
France	Centre Georges François Leclerc	Dijon
France	Centre Léon Bérard	Lyon
France	Hopital de la Timone	Marseille
France	Centre de Lutte Contre le Cancer (CLCC) - Centre Antoine Lacassagne (CAL) - Site Est	Nice
France	Hopital Pitie-Salpetriere	Paris
France	Institut Curie	Paris
France	Civils de Lyon-Centre Hopitalier Lyon Sud	Pierre-benite
France	Hopital Foch	Suresnes
France	Institut Gustave Roussy	Villejuif
Germany	Charite University Medicine	Berlin
Germany	Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III	Bonn
Germany	Universitatsmedizin Gottingen	GÃttingen
Germany	Kath. Marienkrankenhaus gGmbH	Hamburg
Germany	Universitäres Krebszentrum Leipzig	Leipzig
Germany	Technische Universitat Munchen (TUM) - Klinikum Rechts der Isar	Munich
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Princess Margaret Hospital	Lai Chi Kok
Italy	Azienda Ospedaliero - Universitaria di Bologna - IRCCS	Bologna
Italy	ASST degli Spedali Civili di Brescia	Brescia
Italy	Ospedale San Luca Luca	Lucca
Italy	Fondazione IRCCS Istituto Nazionale Tumori Milano	Milan
Italy	Azienda Ospedaliero-Universitaria di Modena - Policlinico	Modena
Italy	Arcispedale Santa Maria Nuova	Reggio Emilia
Italy	Azienda Ospedaliero - Universitaria Senese	Siena
Poland	Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy	Bydgoszcz
Poland	Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie, Panstwowy Instytut Badawczy, Oddzial x Gliwicach	Gliwice
Poland	Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie, Oddzial Onkologii Klinicznej i Immunookologii z Poddoddzialem Dziennym i Izba Przyjec	Poznan
Poland	Wojewodzki Szpital Specjalistyczny w Siedlcach	Siedlce
Poland	Narodowy Instytut Onkologii im. M. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Glowy i Szyi	Warsaw
Portugal	Hospital de Braga	Braga
Portugal	Centro Hospitalar do Algarve	Faro
Portugal	Hospital CUF Descobertas	Lisboa
Portugal	Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA	Matosinhos
Portugal	Centro Hospitalar Universitario do Porto	Porto
Portugal	Instituto Portugues de Oncologia Do Porto Francisco Gentil,E.P.E.	Porto
Spain	Hospital De La Santa Creu I Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario de Jaen	Jaen
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	MD Anderson Cancer Center	Madrid
Spain	Hospital Regional Universitario de Malaga	Malaga
Spain	Clinica Universidad de Navarra	Pamplona
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitari i Politecnic La Fe	Valencia
United Kingdom	Royal Marsden NHS Foundation Trust, Royal Marsden - Sutton	London
United Kingdom	Musgrove Park Hospital	Taunton
United States	University Center and Blood Center,LLC.	Athens	Georgia
United States	Ironwood Cancer and Research Center	Chandler	Arizona
United States	Medical University of South Carolina	Charleston	South Carolina
United States	City of Hope	Duarte	California
United States	Astera Cancer Care	East Brunswick	New Jersey
United States	Sanford Roger Maris Cancer Center	Fargo	North Dakota
United States	Memorial Healthcare System	Hollywood	Florida
United States	MD Anderson Cancer Center	Houston	Texas
United States	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	UCLA Hematology/Oncology	Los Angeles	California
United States	Virginia Piper Cancer Center (Alliant Health	Minneapolis	Minnesota
United States	Icahn School of Medicine at Mount Sinai and the Mount Sinai Hospital	New York	New York
United States	Ocala Oncology Center	Ocala	Florida
United States	OU Health Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	Stanford Cancer Institute	Palo Alto	California
United States	New York Cancer and Blood Specialists	Port Jefferson Station	New York
United States	Torrance Memorial Physician Network - Cancer Care Associates	Redondo Beach	California
United States	Washington University of Medicine- Siteman Cancer Center	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Providence Medical Foundation	Santa Rosa	California
United States	Avera Cancer Institute	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Hong Kong,  Italy,  Poland,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		First Dose up to 21 days
Primary	Phase 2 Cohorts 1: Progression-free Survival (PFS)	PFS is defined as the time from the date of randomization until the earliest date of documented disease progression, as assessed by investigator assessment, or death from any cause, whichever occurs first.	Up to 5 years
Primary	Phase 2 Cohorts 2 and 3: Objective Response Rate (ORR)	ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 as determined by investigator assessment.	Up to 9 months
Secondary	Safety Run-In and Phase 2 Cohorts: Serum Concentration of Magrolimab		Up to end of treatment (approximately 24 months)
Secondary	Safety Run-In and Phase 2 Cohorts: Percentage of Participants who Developed Antidrug Antibodies (ADAs) to Magrolimab		Up to end of treatment (approximately 24 months)
Secondary	Phase 2 Cohorts: Objective Response Rate (ORR)	ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as determined by investigator assessment.	Up to 9 months
Secondary	Phase 2 Cohorts: Progression-free Survival (PFS)	PFS is defined as the time from the date of randomization (Phase 2 Cohorts 1) or date of dose initiation (Phase 2 Cohorts 2 and 3) until the earliest date of documented disease progression as determined by investigator assessment per RECIST, version 1.1, or death from any cause, whichever occurs first.	Up to 5 years
Secondary	Phase 2 Cohorts: Duration of Response (DOR)	DOR is defined as the time from first documentation of CR or PR to the earliest date of documented disease progression or death from any cause, whichever occurs first.	Up to 5 years
Secondary	Phase 2 Cohorts: Overall Survival (OS)	OS is defined as the time from the date of randomization (Phase 2 Cohorts 1) or time from the date of dose initiation (Phase 2 Cohorts 2 and 3) to death from any cause.	Up to 5 years
Secondary	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	The EORTC QLQ-C30 questionnaire is a specific questionnaire for cancer, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant).	Baseline; up to 24 months
Secondary	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)	The head & neck cancer module is a 35-item questionnaire designed for use among a wide range of participants with head & neck cancer, varying in disease stage and treatment modality. It includes 7 multi-item scales that assess pain (4 items), swallowing (4 items), senses (2 items), speech (3 items), social eating (4 items), social contact (5 items), and sexuality (2 items). There are also 11 single items. Using a 4-point Likert scale, participants indicate the degree to which they have experienced symptoms. For all items and scales, high scores indicate more problems.	Baseline; up to 24 months
Secondary	Phase 2 Cohorts: Change From Baseline in the 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L)	The EQ-5D-5L is a standard measure of health-related quality of life. The tool consists of the EQ-5D-5L descriptive part and the EQ visual analogue scale (VAS). The descriptive part comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each of these 5 dimensions has 5 levels (no problem, slight problems, moderate problems, severe problems, and extreme problems). Results for each of the 5 dimensions are combined into a 5-digit number to describe the participant's health state.; The EQ-VAS records the participant's health on a 0-100 mm VAS scale, with 0 indicating "the worst health you can imagine" and 100 indicating "the best health you can imagine." Higher scores of EQ VAS indicate better health.	Baseline; up to 24 months

External Links

•   Gilead Clinical Trials Website