Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma (ELEVATE HNSCC)

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

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 participants with head and neck squamous cell carcinoma (HNSCC).

Study Overview

• Status: Terminated
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Magrolimab; Drug: Docetaxel; Drug: Carboplatin; Drug: Zimberelimab; Drug: Pembrolizumab; Drug: 5-FU; Drug: Cisplatin

• Study Type: Interventional
• Enrollment (Actual): 193
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St. Vincent's Hospital Sydney
    • Macquarie Park, New South Wales, Australia, 2109
      • Macquarie University
    • Westmead, New South Wales, Australia, 2145
      • Blacktown Hospital
  • Queensland
    • Cairns, Queensland, Australia, 4870
      • Cairns Hospital
    • Sippy Downs, Queensland, Australia, 4556
      • University of the Sunshine Coast
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
    • Melbourne, Victoria, Australia, 3004
      • Alfred Health
• Belgium
  • Antwerp, Belgium, 2020
    • ZiekenhuisNetwerk Antwerpen (ZNA) - Stuivenberg
  • Brasschaat, Belgium, 2930
    • Algemeen Ziekenhuis Klina
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuis Leuven
  • Libramont-Chevigny, Belgium, 6800
    • Centre Hospitalizer De L'Ardenne
  • Mechelen, Belgium, 2800
    • AZ Sint-Maarten
  • Namur, Belgium, 5000
    • CHU UCL Namur - Sainte-Elisabeth
• France
  • Bordeaux, France, 33000
    • Institut Bergonie
  • Dijon, France, 21079
    • Centre Georges François Leclerc
  • Lyon, France, 69373
    • Centre Leon Berard
  • Marseille, France, 13005
    • Hopital de la Timone
  • Nice, France, 6189
    • Centre de Lutte Contre le Cancer (CLCC) - Centre Antoine Lacassagne (CAL) - Site Est
  • Paris, France, 75005
    • Institut Curie
  • Paris, France, 75013
    • Hopital Pitie-Salpetriere
  • Pierre-Bénite, France, 69310
    • Civils de Lyon-Centre Hopitalier Lyon Sud
  • Suresnes, France, 92151
    • Hopital Foch
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Germany
  • Berlin, Germany, 10177
    • Charite University Medicine
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III
  • GÃttingen, Germany, 37075
    • Universitätsmedizin Göttingen
  • Hamburg, Germany, 22087
    • Kath. Marienkrankenhaus gGmbH
  • Leipzig, Germany, 4103
    • Universitares Krebszentrum Leipzig
  • Munich, Germany, 81675
    • Technische Universitat Munchen (TUM) - Klinikum Rechts der Isar
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Lai Chi Kok, Hong Kong
    • Princess Margaret Hospital
• Italy
  • Bologna, Italy, 40138
    • Azienda Ospedaliero - Universitaria di Bologna - IRCCS
  • Brescia, Italy, 25123
    • ASST degli Spedali Civili di Brescia
  • Lucca, Italy, 55100
    • Ospedale San Luca Luca
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale Tumori Milano
  • Modena, Italy, 41124
    • Azienda Ospedaliero-Universitaria di Modena - Policlinico
  • Reggio Emilia, Italy, 42100
    • Arcispedale Santa Maria Nuova
  • Siena, Italy, 53100
    • Azienda Ospedaliero - Universitaria Senese
• Poland
  • Bydgoszcz, Poland, 85-796
    • Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
  • Gliwice, Poland, 44-102
    • Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie, Panstwowy Instytut Badawczy, Oddzial x Gliwicach
  • Poznan, Poland, 61-866
    • Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie, Oddzial Onkologii Klinicznej i Immunookologii z Poddoddzialem Dziennym i Izba Przyjec
  • Siedlce, Poland, 08-110
    • Wojewodzki Szpital Specjalistyczny w Siedlcach
  • Warsaw, Poland, 2781
    • Narodowy Instytut Onkologii im. M. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Glowy i Szyi
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga
  • Faro, Portugal, 8000-366
    • Centro Hospitalar do Algarve
  • Lisbon, Portugal, 1998-018
    • Hospital CUF Descobertas
  • Matosinhos Municipality, Portugal, 4464-513
    • Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA
  • Porto, Portugal, 4050-011
    • Centro Hospitalar Universitario do Porto
  • Porto, Portugal, 4200-072
    • Instituto Portugues de Oncologia Do Porto Francisco Gentil,E.P.E.
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 8041
    • Hospital De La Santa Creu I Sant Pau
  • Barcelona, Spain, 8003
    • Hospital del Mar
  • Jaén, Spain, 23007
    • Hospital Universitario de Jaen
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28033
    • MD Anderson Cancer Center
  • Málaga, Spain, 29010
    • Hospital Regional Universitario de Málaga
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
  • Valencia, Spain
    • Hospital Clinico Universitario de Valencia
• United Kingdom
  • London, United Kingdom, SM2 5PT
    • Royal Marsden NHS Foundation Trust, Royal Marsden - Sutton
  • Taunton, United Kingdom, TA1 5DA
    • Musgrove Park Hospital
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Ironwood Cancer and Research Center
  • California
    • Duarte, California, United States, 91010
      • City of Hope
    • Los Angeles, California, United States, 90095
      • UCLA Hematology/Oncology
    • Palo Alto, California, United States, 94305
      • Stanford Cancer Institute
    • Redondo Beach, California, United States, 90277
      • Torrance Memorial Physician Network - Cancer Care Associates
    • Santa Rosa, California, United States, 95403
      • Providence Medical Foundation
  • Florida
    • Hollywood, Florida, United States, 33021
      • Memorial Healthcare System
    • Ocala, Florida, United States, 34471
      • Ocala Oncology Center
  • Georgia
    • Athens, Georgia, United States, 30607
      • University Center and Blood Center,LLC.
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Melvin and Bren Simon Cancer Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Virginia Piper Cancer Center (Alliant Health
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University of Medicine- Siteman Cancer Center
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Astera Cancer Care
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai and the Mount Sinai Hospital
    • Port Jefferson Station, New York, United States, 11776
      • New York Cancer and Blood Specialists
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • Sanford Roger Maris Cancer Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • OU Health Stephenson Cancer Center
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17602
      • Lancaster General Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B); Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive pembrolizumab 200 mg on Day 1 of each cycle, 5-FU 1000 mg/m^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first.	Drug: Carboplatin; Administered intravenously; Drug: 5-FU; Administered intravenously; Drug: Cisplatin; Administered intravenously
Experimental: Phase 2 Cohort 2, Magrolimab + Pembrolizumab; Participants with untreated metastatic or unresectable, locally recurrent HNSCC with a PD-L1 combined positive score (CPS) ≥ 1 will receive magrolimab at the RP2D determined in the Safety run-in cohort 1 and pembrolizumab 200 mg on Day 1 of each cycle. Each cycle is 21 days. Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first.	Drug: Magrolimab; Administered intravenously; Other Names: GS-4721; Drug: Pembrolizumab; Administered intravenously; Other Names: KEYTRUDA®
Experimental: Phase 2 Cohort 3, Magrolimab + Docetaxel; Participants with locally advanced/metastatic HNSCC regardless of PD-L1 status who were previously treated with at least 1 and no more than 2 lines of prior systemic therapy will receive magrolimab at the RP2D determined in the Safety run-in cohort 2 and docetaxel 75 mg/m^2 on Day 1 of each cycle. Each cycle is 21 days. Magrolimab and docetaxel will be continued until loss of clinical benefit, unacceptable toxicity, or death.	Drug: Magrolimab; Administered intravenously; Other Names: GS-4721; Drug: Docetaxel; Administered intravenously
Experimental: Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum; Participants with untreated metastatic or unresectable, locally recurrent head and neck squamous cell carcinoma (HNSCC) regardless of programmed cell death ligand 1 (PD-L1) status will receive the following: magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses; pembrolizumab 200 mg on Day 1 of each cycle; 5-fluorouracil (5-FU) 1000 mg/m^2/day Days 1-4 of each cycle (for up to 6 cycles); platinum chemotherapy (cisplatin 100 mg/m^2 or carboplatin area under the concentration versus time curve (AUC) 5 per investigator choice (for up to 6 cycles)) Participants will continue treatment until unacceptable toxicity or disease progression, whichever occurs first, and will not change their magrolimab dose level after the recommended Phase 2 dose (RP2D) is determined. Each cycle is 21 days.	Drug: Magrolimab; Administered intravenously; Other Names: GS-4721; Drug: Carboplatin; Administered intravenously; Drug: Pembrolizumab; Administered intravenously; Other Names: KEYTRUDA®; Drug: 5-FU; Administered intravenously; Drug: Cisplatin; Administered intravenously
Experimental: Safety Run-in Cohort 2, Magrolimab + Docetaxel; Participants with locally advanced/metastatic HNSCC regardless of PD-L1 status who were previously treated with at least 1 and no more than 2 lines of prior systemic therapy will receive the following: magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses; docetaxel 75 mg/m^2 on Day 1 of each cycle Participants will continue treatment until unacceptable toxicity or disease progression, whichever occurs first, and will not change their magrolimab dose level after the RP2D is determined. Each cycle is 21 days.	Drug: Magrolimab; Administered intravenously; Other Names: GS-4721; Drug: Docetaxel; Administered intravenously
Experimental: Pre-expansion Safety Run-in Cohort, Magrolimab + Pembrolizumab; The pre-expansion safety run-in cohort may be conducted at the sponsor's discretion prior to the initiation of Phase 2 Cohort 2. Participants with untreated metastatic or unresectable, locally recurrent HNSCC with a PD-L1 combined positive score (CPS) ≥ 1 will receive magrolimab and pembrolizumab 200 mg on Day 1 of each cycle. Each cycle is 21 days. Participants will continue treatment until unacceptable toxicity or disease progression, whichever occurs first, and will not change their magrolimab dose level after the RP2D is determined. Each cycle is 21 days.	Drug: Magrolimab; Administered intravenously; Other Names: GS-4721; Drug: Pembrolizumab; Administered intravenously; Other Names: KEYTRUDA®
Experimental: Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A); Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety run-in cohort 1, pembrolizumab 200 mg on Day 1 of each cycle, 5-FU 1000 mg/m^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first.	Drug: Magrolimab; Administered intravenously; Other Names: GS-4721; Drug: Carboplatin; Administered intravenously; Drug: Pembrolizumab; Administered intravenously; Other Names: KEYTRUDA®; Drug: 5-FU; Administered intravenously; Drug: Cisplatin; Administered intravenously
Active Comparator: Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C); Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety run-in cohort 1, zimberelimab 360 mg on Day 1 of each cycle, 5- FU 1000 mg/m^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Zimberelimab therapy will be administered up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first.	Drug: Magrolimab; Administered intravenously; Other Names: GS-4721; Drug: Carboplatin; Administered intravenously; Drug: Zimberelimab; Administered intravenously; Drug: 5-FU; Administered intravenously; Drug: Cisplatin; Administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Run-in Cohorts 1 and 2: 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	A DLT was defined as any Grade 3 or higher hematologic toxicity or Grade 3 or higher nonhematologic toxicity that had worsened in severity from pretreatment baseline during the DLT assessment period and, in the opinion of the investigator, the AE was related to magrolimab and the relationship of the AE with the combination partner regimen can be ruled out.	First dose date up to 21 days
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities	Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point up to and including last dose date of study drug plus 30 days (or last dose date of zimberelimab plus 90 days) and prior to the day of initiation of subsequent anti-cancer therapy.	First dose date up to 73 weeks plus 30 days
Phase 2 Cohort 1, Arms A and B: Progression-free Survival (PFS)	PFS was 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 occurred first. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Kaplan-Meier (KM) estimates were used in outcome measure analysis.	Up to 129 weeks
Phase 2 Cohort 3: Objective Response Rate (ORR)	ORR was defined as the percentage of participants who achieved 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. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	Up to 129 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab		Day 8 1-Hour Postdose; Days 15, 22, 43: Predose; Day 43 1-Hour Postdose; Day 71 1-Hour Postdose; Days 85,127, 190,197, 211, 253 Predose; Day 253 1-Hour Postdose
Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A, C and Phase 2 Cohort 3: Percentage of Participants Who Developed Antidrug Antibodies (ADAs) to Magrolimab		Up to end of treatment (up to approximately 73 weeks)
Phase 2 Cohort 1, Arms B and C: Progression-free Survival (PFS)	PFS was 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. Disease progression is defined in OM#2. KM estimates were used in outcome measure analysis.	Up to 129 weeks
Phase 2 Cohort 1, Arms A, B and C: Objective Response Rate (ORR)	ORR was defined as the percentage of participants who achieved a CR or PR as determined by investigator assessment. CR and PR are defined in OM#3.	Up to 129 weeks
Phase 2 Cohort 3: Progression-free Survival (PFS)	PFS was defined as the time from the date of dose initiation (Phase 2 Cohort 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. Disease progression is defined in OM#2. KM estimates were used in outcome measure analysis	Up to 129 weeks
All Phase 2 Cohorts: Duration of Response (DOR)	DOR was 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. Disease progression is defined in OM#2 and CR and PR are defined in OM#3.	Up to 129 weeks
All Phase 2 Cohorts: Overall Survival (OS)	OS was defined as the time from the date of randomization (Phase 2 Cohorts 1) or time from the date of dose initiation (Phase 2) to death from any cause. KM estimates were used in outcome measure analysis.	Up to 129 weeks
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	EORTC QLQ-C30 is a quality of life (QOL) questionnaire for cancer participants, that has 30 items. 5 functional scales (physical, role, emotional, cognitive, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial difficulties). Scoring of the QLQ-C30 was 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 indicated a higher level of symptoms (i.e. a worse state of the participant).	Baseline, Week 3, Week 6, Week 9, Week 12, Week 15, Week 18, Week 21, Week 24, Week 27 and Week 90
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 H&N35 is a 35-item questionnaire for participants with H&N cancer. 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: teeth, opening mouth, dry mouth, sticky saliva, coughing, felt ill, pain killers, nutritional supplements, feeding tube, weight loss, weight gain. All symptoms scales, scores were transformed in range of 0 to 100, where higher scores indicated more severe symptoms. A negative change from Baseline indicated improvement.	Baseline, Week 3, Week 6, Week 9, Week 12, Week 15, Week 18, Week 21, Week 24, Week 27, and Week 90
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score	EQ-5D-5L was an instrument for use as a measure of health outcome. The EQ-5D-5L consisted of 2 sections: EuroQoL (5 dimensions) (EQ-5D) descriptive system and the EuroQoL visual analogue scale (EQ-VAS). EQ-5D comprised the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Number of participants per category are reported.	Baseline, Week 3, Week 6, Week 9, Week 12, Week 15, Week 18, Week 21, Week 24, Week 27 and Week 90
Phase 2 Cohorts: Change From Baseline in the EuroQol Visual Analogue Scale (EQ-VAS) Score	The EQ-VAS recorded the participant's self-rated health on a vertical VAS, where the end points were labeled "the best health you can imagine" and "the worst health you can imagine." The EQ-VAS could be used as a quantitative measure of a health outcome that reflected the participant's own judgment. The EQ-VAS recorded the participant's self-rated health on a vertical VAS, with a score numbered from 0 to 100, where '100 meant the best health you can imagine' and '0 meant the worst health you can imagine".	Baseline, Week 3, Week 6, Week 9, Week 12, Week 15, Week 18, Week 21, Week 24, Week 27 and Week 90

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

General Publications

• Colevas AD, Dinis J, Chin V, Costa DA, Park JJ, Fang B, et al. A Phase 2 Study of Magrolimab Combination Therapy in Patients with Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma (ELEVATE HNSCC) [Poster TPS6102]. American Society for Clinical Oncology (ASCO); 2023 June 2-6; Chicago, IL.
• Colevas AD, Dinis J, Chin V, Costa DA, Park JJ, Fang B, et al. A phase 2 study of magrolimab combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (ELEVATE HNSCC) [Abstract]. American Society for Clinical Oncology (ASCO); 2023 June 2-6; Chicago, IL.
• Colevas AD, Kerrigan K, Chin V, Rainey N, Park J, Fang B, et al. Safety and Tolerability of Magrolimab Combination Therapy in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (RM-HNSCC) [Poster #675]. SITC: 38th Society for Immunotherapy of Cancer Annual Meeting; 2023 November 3-5, 2023; San Diego, CA.
• Colevas AD, Kerrigan K, Chin V, Rainey N, Park J, Fang B, et al. Safety and tolerability of magrolimab combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM-HNSCC) [Abstract]. SITC: 38th Society for Immunotherapy of Cancer Annual Meeting; 2023 November 3-5, 2023; San Diego, CA.

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2021
• Primary Completion (Actual): October 2, 2024
• Study Completion (Actual): October 2, 2024

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 6, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Taxoids; Cyclodecanes; Diterpenes; Pyrimidines; Uracil; Pyrimidinones; Platinum Compounds; Docetaxel; Fluorouracil; Carboplatin; Cisplatin; pembrolizumab; zimberelimab; magrolimab
• Other Study ID Numbers: GS-US-548-5916; 2020-005708-20 (Other Identifier: EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No