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

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Magrolimab
Pembrolizumab
Docetaxel
5-FU
Cisplatin
Carboplatin
Zimberelimab
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

  • Progressive disease within 6 months of completion of curatively intended systemic treatment for locally advanced/mHNSCC
  • Prior treatment with a taxane

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

Sites / Locations

  • Ironwood Cancer and Research CenterRecruiting
  • City of HopeRecruiting
  • UCLA Hematology/OncologyRecruiting
  • Stanford Cancer InstituteRecruiting
  • Torrance Memorial Physician Network - Cancer Care AssociatesRecruiting
  • Providence Medical FoundationRecruiting
  • Ocala Oncology CenterRecruiting
  • University Center and Blood Center,LLC.Recruiting
  • Indiana University Melvin and Bren Simon Cancer CenterRecruiting
  • Virginia Piper Cancer Center (Alliant HealthRecruiting
  • Washington University of Medicine- Siteman Cancer CenterRecruiting
  • Astera Cancer CareRecruiting
  • Icahn School of Medicine at Mount Sinai and the Mount Sinai Hospital
  • New York Cancer and Blood SpecialistsRecruiting
  • Sanford Roger Maris Cancer CenterRecruiting
  • OU Health Stephenson Cancer CenterRecruiting
  • Oregon Health and Science University
  • Lancaster General HospitalRecruiting
  • Medical University of South CarolinaRecruiting
  • Avera Cancer InstituteRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Huntsman Cancer InstituteRecruiting
  • St. Vincent's Hospital SydneyRecruiting
  • Macquarie UniversityRecruiting
  • Blacktown HospitalRecruiting
  • Cairns HospitalRecruiting
  • University of the Sunshine CoastRecruiting
  • Princess Alexandra HospitalRecruiting
  • Austin HealthRecruiting
  • Alfred HealthRecruiting
  • ZiekenhuisNetwerk Antwerpen (ZNA) - StuivenbergRecruiting
  • Algemeen Ziekenhuis KlinaRecruiting
  • UZ AntwerpenRecruiting
  • Universitaire Ziekenhuis LeuvenRecruiting
  • Centre Hospitalizer De L'ArdenneRecruiting
  • AZ Sint-MaartenRecruiting
  • CHU UCL Namur - Sainte-ElisabethRecruiting
  • Institut BergonieRecruiting
  • Centre Georges François LeclercRecruiting
  • Centre Léon BérardRecruiting
  • Hopital de la TimoneRecruiting
  • Centre de Lutte Contre le Cancer (CLCC) - Centre Antoine Lacassagne (CAL) - Site EstRecruiting
  • Institut CurieRecruiting
  • Hopital Pitie-SalpetriereRecruiting
  • Civils de Lyon-Centre Hopitalier Lyon SudRecruiting
  • Hopital FochRecruiting
  • Institut Gustave RoussyRecruiting
  • Charite University MedicineRecruiting
  • Universitatsmedizin GottingenRecruiting
  • Kath. Marienkrankenhaus gGmbHRecruiting
  • Universitäres Krebszentrum LeipzigRecruiting
  • Technische Universitat Munchen (TUM) - Klinikum Rechts der IsarRecruiting
  • Hong Kong United Oncology Centre
  • Queen Mary HospitalRecruiting
  • Princess Margaret HospitalRecruiting
  • Hong Kong Sanatorium and Hospital
  • Azienda Ospedaliero - Universitaria di Bologna - IRCCSRecruiting
  • ASST degli Spedali Civili di BresciaRecruiting
  • Azienda Ospedaliera Spedali Civili di BresciaRecruiting
  • Ospedale San Luca LucaRecruiting
  • Fondazione IRCCS Istituto Nazionale Tumori MilanoRecruiting
  • Arcispedale Santa Maria NuovaRecruiting
  • Azienda Ospedaliero - Universitaria SeneseRecruiting
  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka w BydgoszczyRecruiting
  • Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie, Panstwowy Instytut Badawczy, Oddzial x GliwicachRecruiting
  • Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie, Oddzial Onkologii Klinicznej i Immunookologii z Poddoddzialem Dziennym i Izba PrzyjecRecruiting
  • Wojewodzki Szpital Specjalistyczny w SiedlcachRecruiting
  • Narodowy Instytut Onkologii im. M. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Glowy i SzyiRecruiting
  • Hospital de BragaRecruiting
  • Centro Hospitalar do AlgarveRecruiting
  • Hospital CUF DescobertasRecruiting
  • Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SARecruiting
  • Centro Hospitalar Universitario do PortoRecruiting
  • Instituto Portugues de Oncologia Do Porto Francisco Gentil,E.P.E.Recruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital del MarRecruiting
  • Hospital De La Santa Creu I Sant PauRecruiting
  • Hospital Universitario de JaenRecruiting
  • Hospital General Universitario Gregorio MaranonRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Regional Universitario de MalagaRecruiting
  • Clinica Universidad de NavarraRecruiting
  • Hospital Universitario Virgen MacarenaRecruiting
  • Hospital Universitario Virgen del RocioRecruiting
  • Hospital Universitari i Politecnic La FeRecruiting
  • Hospital Clínico Universitario de ValenciaRecruiting
  • Royal Marsden NHS Foundation Trust, Royal Marsden - SuttonRecruiting
  • Musgrove Park HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum

Safety Run-in Cohort 2, Magrolimab + Docetaxel

Pre-expansion Safety Run-in Cohort, Magrolimab + Pembrolizumab

Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A)

Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B)

Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C)

Phase 2 Cohort 2, Magrolimab + Pembrolizumab

Phase 2 Cohort 3, Magrolimab + Docetaxel

Arm Description

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 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.

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 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.

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.

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.

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.

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 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.

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.

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.

Outcomes

Primary Outcome Measures

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
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 independent central review, or death from any cause, whichever occurs first.
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.

Secondary Outcome Measures

Safety Run-In and Phase 2 Cohorts: Serum Concentration of Magrolimab
Safety Run-In and Phase 2 Cohorts: Percentage of Participants who Developed Antidrug Antibodies (ADAs) to Magrolimab
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 independent central review.
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.
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.
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.
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).
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.
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.

Full Information

First Posted
April 19, 2021
Last Updated
October 20, 2023
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04854499
Brief Title
Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
Acronym
ELEVATE HNSCC
Official Title
A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum
Arm Type
Experimental
Arm Description
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 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.
Arm Title
Safety Run-in Cohort 2, Magrolimab + Docetaxel
Arm Type
Experimental
Arm Description
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 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.
Arm Title
Pre-expansion Safety Run-in Cohort, Magrolimab + Pembrolizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A)
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C)
Arm Type
Experimental
Arm Description
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 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.
Arm Title
Phase 2 Cohort 2, Magrolimab + Pembrolizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase 2 Cohort 3, Magrolimab + Docetaxel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Magrolimab
Other Intervention Name(s)
GS-4721
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Zimberelimab
Intervention Description
Administered intravenously
Primary Outcome Measure Information:
Title
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
Time Frame
First Dose up to 21 days
Title
Phase 2 Cohorts 1: Progression-free survival (PFS)
Description
PFS is defined as the time from the date of randomization until the earliest date of documented disease progression, as assessed by independent central review, or death from any cause, whichever occurs first.
Time Frame
Up to 5 years
Title
Phase 2 Cohorts 2 and 3: Objective Response Rate (ORR)
Description
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.
Time Frame
Up to 9 months
Secondary Outcome Measure Information:
Title
Safety Run-In and Phase 2 Cohorts: Serum Concentration of Magrolimab
Time Frame
Up to end of treatment (approximately 24 months)
Title
Safety Run-In and Phase 2 Cohorts: Percentage of Participants who Developed Antidrug Antibodies (ADAs) to Magrolimab
Time Frame
Up to end of treatment (approximately 24 months)
Title
Phase 2 Cohorts: Objective Response Rate (ORR)
Description
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as determined by independent central review.
Time Frame
Up to 9 months
Title
Phase 2 Cohorts: Progression-free survival (PFS)
Description
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.
Time Frame
Up to 5 years
Title
Phase 2 Cohorts: Duration of Response (DOR)
Description
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.
Time Frame
Up to 5 years
Title
Phase 2 Cohorts: Overall Survival (OS)
Description
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.
Time Frame
Up to 5 years
Title
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
Description
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).
Time Frame
Baseline; up to 24 months
Title
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)
Description
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.
Time Frame
Baseline; up to 24 months
Title
Phase 2 Cohorts: Change From Baseline in the 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L)
Description
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.
Time Frame
Baseline; up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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 Progressive disease within 6 months of completion of curatively intended systemic treatment for locally advanced/mHNSCC Prior treatment with a taxane Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilead Clinical Study Information Center
Phone
1-833-445-3230 (GILEAD-0)
Email
GileadClinicalTrials@gilead.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Ironwood Cancer and Research Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
UCLA Hematology/Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Stanford Cancer Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Name
Torrance Memorial Physician Network - Cancer Care Associates
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Medical Foundation
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Individual Site Status
Recruiting
Facility Name
Ocala Oncology Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Individual Site Status
Recruiting
Facility Name
University Center and Blood Center,LLC.
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Piper Cancer Center (Alliant Health
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University of Medicine- Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Astera Cancer Care
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Individual Site Status
Recruiting
Facility Name
Icahn School of Medicine at Mount Sinai and the Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
New York Cancer and Blood Specialists
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Individual Site Status
Recruiting
Facility Name
Sanford Roger Maris Cancer Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Individual Site Status
Recruiting
Facility Name
OU Health Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Withdrawn
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Name
Macquarie University
City
Macquarie Park
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Recruiting
Facility Name
Blacktown Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
Cairns Hospital
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Individual Site Status
Recruiting
Facility Name
University of the Sunshine Coast
City
Sippy Downs
State/Province
Queensland
ZIP/Postal Code
4556
Country
Australia
Individual Site Status
Recruiting
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
Alfred Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
ZiekenhuisNetwerk Antwerpen (ZNA) - Stuivenberg
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Algemeen Ziekenhuis Klina
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitaire Ziekenhuis Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centre Hospitalizer De L'Ardenne
City
Libramont-Chevigny
ZIP/Postal Code
6800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Sint-Maarten
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU UCL Namur - Sainte-Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital de la Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Name
Centre de Lutte Contre le Cancer (CLCC) - Centre Antoine Lacassagne (CAL) - Site Est
City
Nice
ZIP/Postal Code
6189
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
Civils de Lyon-Centre Hopitalier Lyon Sud
City
Pierre-benite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
Charite University Medicine
City
Berlin
ZIP/Postal Code
10177
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsmedizin Gottingen
City
GÃttingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Name
Kath. Marienkrankenhaus gGmbH
City
Hamburg
ZIP/Postal Code
22087
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitäres Krebszentrum Leipzig
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Technische Universitat Munchen (TUM) - Klinikum Rechts der Isar
City
Munich
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Name
Hong Kong United Oncology Centre
City
Hong Kong
Country
Hong Kong
Individual Site Status
Withdrawn
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Princess Margaret Hospital
City
Lai Chi Kok
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Hong Kong Sanatorium and Hospital
City
Wan Chai
ZIP/Postal Code
999077
Country
Hong Kong
Individual Site Status
Withdrawn
Facility Name
Azienda Ospedaliero - Universitaria di Bologna - IRCCS
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST degli Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Luca Luca
City
Lucca
ZIP/Postal Code
55100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Istituto Nazionale Tumori Milano
City
Milan
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Arcispedale Santa Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero - Universitaria Senese
City
Siena
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Name
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie, Panstwowy Instytut Badawczy, Oddzial x Gliwicach
City
Gliwice
ZIP/Postal Code
44-102
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie, Oddzial Onkologii Klinicznej i Immunookologii z Poddoddzialem Dziennym i Izba Przyjec
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewodzki Szpital Specjalistyczny w Siedlcach
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Individual Site Status
Recruiting
Facility Name
Narodowy Instytut Onkologii im. M. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Glowy i Szyi
City
Warsaw
ZIP/Postal Code
2781
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar do Algarve
City
Faro
ZIP/Postal Code
8000-366
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital CUF Descobertas
City
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitario do Porto
City
Porto
ZIP/Postal Code
4050-011
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Instituto Portugues de Oncologia Do Porto Francisco Gentil,E.P.E.
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital De La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
8041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Jaen
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario de Malaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Name
Royal Marsden NHS Foundation Trust, Royal Marsden - Sutton
City
London
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Musgrove Park Hospital
City
Taunton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-548-5916
Description
Gilead Clinical Trials Website

Learn more about this trial

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

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