Head and Neck Squamous Cell CarcinomaPhase 2ELEVATE HNSCCNCT04854499
Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Magrolimab, Pembrolizumab and Docetaxel in people with Head and Neck Squamous Cell Carcinoma, run by Gilead Sciences at 88 sites in 11 countries.
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 participants with head and neck squamous cell carcinoma (HNSCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Magrolimab, Pembrolizumab and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 88 sitesin 11 countries
- Study dates
- 7 Sep 2021to 2 Oct 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
88 sites in 11 countries.
88 sites in 11 countries
United States22 sites
University Center and Blood Center,LLC.
Athens, Georgia, 30607
Ironwood Cancer and Research Center
Chandler, Arizona, 85224
Medical University of South Carolina
Charleston, South Carolina, 29425
City of Hope
Duarte, California, 91010
Astera Cancer Care
East Brunswick, New Jersey, 08816
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Memorial Healthcare System
Hollywood, Florida, 33021
MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
UCLA Hematology/Oncology
Los Angeles, California, 90095
Virginia Piper Cancer Center (Alliant Health
Minneapolis, Minnesota, 55407
Icahn School of Medicine at Mount Sinai and the Mount Sinai Hospital
New York, New York, 10029
Ocala Oncology Center
Ocala, Florida, 34471
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Stanford Cancer Institute
Palo Alto, California, 94305
New York Cancer and Blood Specialists
Port Jefferson Station, New York, 11776
Torrance Memorial Physician Network - Cancer Care Associates
Redondo Beach, California, 90277
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Providence Medical Foundation
Santa Rosa, California, 95403
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Washington University of Medicine- Siteman Cancer Center
St Louis, Missouri, 63110
Spain13 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital del Mar
Barcelona, 8003
Hospital De La Santa Creu I Sant Pau
Barcelona, 8041
Hospital Universitario de Jaen
Jaén, 23007
Hospital General Universitario Gregorio Maranon
Madrid, 28007
MD Anderson Cancer Center
Madrid, 28033
Hospital Universitario La Paz
Madrid, 28046
Hospital Regional Universitario de Malaga
Málaga, 29010
Clinica Universidad de Navarra
Pamplona, 31008
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Hospital Clínico Universitario de Valencia
Valencia
France10 sites
Institut Bergonie
Bordeaux, 33000
Centre Georges François Leclerc
Dijon, 21079
Centre Léon Bérard
Lyon, 69373
Hopital de la Timone
Marseille, 13005
Centre de Lutte Contre le Cancer (CLCC) - Centre Antoine Lacassagne (CAL) - Site Est
Nice, 6189
Institut Curie
Paris, 75005
Hopital Pitie-Salpetriere
Paris, 75013
Civils de Lyon-Centre Hopitalier Lyon Sud
Pierre-Bénite, 69310
Hopital Foch
Suresnes, 92151
Institut Gustave Roussy
Villejuif, 94805
Australia8 sites
Cairns Hospital
Cairns, Queensland, 4870
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
Austin Health
Heidelberg, Victoria, 3084
Macquarie University
Macquarie Park, New South Wales, 2109
Alfred Health
Melbourne, Victoria, 3004
University of the Sunshine Coast
Sippy Downs, Queensland, 4556
Blacktown Hospital
Westmead, New South Wales, 2145
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Belgium7 sites
ZiekenhuisNetwerk Antwerpen (ZNA) - Stuivenberg
Antwerp, 2020
Algemeen Ziekenhuis Klina
Brasschaat, 2930
UZ Antwerpen
Edegem, 2650
Universitaire Ziekenhuis Leuven
Leuven, 3000
Centre Hospitalizer De L'Ardenne
Libramont-Chevigny, 6800
AZ Sint-Maarten
Mechelen, 2800
CHU UCL Namur - Sainte-Elisabeth
Namur, 5000
Italy7 sites
Azienda Ospedaliero - Universitaria di Bologna - IRCCS
Bologna, 40138
ASST degli Spedali Civili di Brescia
Brescia, 25123
Ospedale San Luca Luca
Lucca, 55100
Fondazione IRCCS Istituto Nazionale Tumori Milano
Milan, 20133
Azienda Ospedaliero-Universitaria di Modena - Policlinico
Modena, 41124
Arcispedale Santa Maria Nuova
Reggio Emilia, 42100
Azienda Ospedaliero - Universitaria Senese
Siena, 53100
Germany6 sites
Charite University Medicine
Berlin, 10177
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III
Bonn, 53127
Universitatsmedizin Gottingen
GÃttingen, 37075
Kath. Marienkrankenhaus gGmbH
Hamburg, 22087
Universitäres Krebszentrum Leipzig
Leipzig, 4103
Technische Universitat Munchen (TUM) - Klinikum Rechts der Isar
Munich, 81675
Portugal6 sites
Hospital de Braga
Braga, 4710-243
Centro Hospitalar do Algarve
Faro, 8000-366
Hospital CUF Descobertas
Lisbon, 1998-018
Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA
Matosinhos Municipality, 4464-513
Centro Hospitalar Universitario do Porto
Porto, 4050-011
Instituto Portugues de Oncologia Do Porto Francisco Gentil,E.P.E.
Porto, 4200-072
Poland5 sites
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
Bydgoszcz, 85-796
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie, Panstwowy Instytut Badawczy, Oddzial x Gliwicach
Gliwice, 44-102
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie, Oddzial Onkologii Klinicznej i Immunookologii z Poddoddzialem Dziennym i Izba Przyjec
Poznan, 61-866
Wojewodzki Szpital Specjalistyczny w Siedlcach
Siedlce, 08-110
Narodowy Instytut Onkologii im. M. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Glowy i Szyi
Warsaw, 2781
Hong Kong2 sites
Queen Mary Hospital
Hong Kong
Princess Margaret Hospital
Lai Chi Kok
United Kingdom2 sites
Royal Marsden NHS Foundation Trust, Royal Marsden - Sutton
London, SM2 5PT
Musgrove Park Hospital
Taunton, TA1 5DA
About this study
Official title: 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).
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Magrolimab, Pembrolizumab, Docetaxel, 5-FU, Cisplatin
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagrolimabDrug
Also called GS-4721
Administered intravenously
PembrolizumabDrug
Also called KEYTRUDA®
Administered intravenously
DocetaxelDrug
Administered intravenously
5-FUDrug
Administered intravenously
CisplatinDrug
Administered intravenously
CarboplatinDrug
Administered intravenously
ZimberelimabDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum | Experimental | 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. Receives: Drug: Magrolimab; Drug: Pembrolizumab; Drug: 5-FU; Drug: Cisplatin; Drug: Carboplatin |
| Safety Run-in Cohort 2, Magrolimab + Docetaxel | Experimental | 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. Receives: Drug: Magrolimab; Drug: Docetaxel |
| Pre-expansion Safety Run-in Cohort, Magrolimab + Pembrolizumab | Experimental | 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. Receives: Drug: Magrolimab; Drug: Pembrolizumab |
| Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A) | Experimental | 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. Receives: Drug: Magrolimab; Drug: Pembrolizumab; Drug: 5-FU; Drug: Cisplatin; Drug: Carboplatin |
| Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B) | Active comparator | 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. Receives: Drug: 5-FU; Drug: Cisplatin; Drug: Carboplatin |
| Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C) | Active comparator | 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. Receives: Drug: Magrolimab; Drug: 5-FU; Drug: Cisplatin; Drug: Carboplatin; Drug: Zimberelimab |
| Phase 2 Cohort 2, Magrolimab + Pembrolizumab | Experimental | 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. Receives: Drug: Magrolimab; Drug: Pembrolizumab |
| Phase 2 Cohort 3, Magrolimab + Docetaxel | Experimental | 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. Receives: Drug: Magrolimab; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 129 weeks
Secondary outcomes (11)
Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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".
Measured: Baseline, Week 3, Week 6, Week 9, Week 12, Week 15, Week 18, Week 21, Week 24, Week 27 and Week 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start7 Sep 2021
- Primary completion2 Oct 2024
- Study completion2 Oct 2024
Why it stopped: Sponsor decision to terminate study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854499
- Sponsor's protocol ID
- GS-US-548-5916
- Other IDs
- 2020-005708-20
- Acronym
- ELEVATE HNSCC
- Status last verified
- Nov 2025
- First submitted
- 19 Apr 2021
- Last updated
- 19 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04854499
- Acronym / sponsor ID
- ELEVATE HNSCC / GS-US-548-5916
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to terminate study
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Posted 19 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum | Experimental | Drug: Magrolimab, Drug: Pembrolizumab, Drug: 5-FU, Drug: Cisplatin, Drug: CarboplatinParticipants 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. |
| Safety Run-in Cohort 2, Magrolimab + Docetaxel | Experimental | Drug: Magrolimab, Drug: DocetaxelParticipants 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. |
| Pre-expansion Safety Run-in Cohort, Magrolimab + Pembrolizumab | Experimental | Drug: Magrolimab, Drug: PembrolizumabThe 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. |
| Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A) | Experimental | Drug: Magrolimab, Drug: Pembrolizumab, Drug: 5-FU, Drug: Cisplatin, Drug: CarboplatinParticipants 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. |
| Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B) | Active comparator | Drug: 5-FU, Drug: Cisplatin, Drug: CarboplatinParticipants 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. |
| Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C) | Active comparator | Drug: Magrolimab, Drug: 5-FU, Drug: Cisplatin, Drug: Carboplatin, Drug: ZimberelimabParticipants 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. |
| Phase 2 Cohort 2, Magrolimab + Pembrolizumab | Experimental | Drug: Magrolimab, Drug: PembrolizumabParticipants 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. |
| Phase 2 Cohort 3, Magrolimab + Docetaxel | Experimental | Drug: Magrolimab, Drug: DocetaxelParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagrolimabAlso: GS-4721Administered intravenously | Drug | Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A), Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C), Phase 2 Cohort 2, Magrolimab + Pembrolizumab, Phase 2 Cohort 3, Magrolimab + Docetaxel, Pre-expansion Safety Run-in Cohort, Magrolimab + Pembrolizumab, Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum, Safety Run-in Cohort 2, Magrolimab + Docetaxel |
| PembrolizumabAlso: KEYTRUDA®Administered intravenously | Drug | Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A), Phase 2 Cohort 2, Magrolimab + Pembrolizumab, Pre-expansion Safety Run-in Cohort, Magrolimab + Pembrolizumab, Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum |
| DocetaxelAdministered intravenously | Drug | Phase 2 Cohort 3, Magrolimab + Docetaxel, Safety Run-in Cohort 2, Magrolimab + Docetaxel |
| 5-FUAdministered intravenously | Drug | Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A), Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C), Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B), Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum |
| CisplatinAdministered intravenously | Drug | Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A), Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C), Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B), Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum |
| CarboplatinAdministered intravenously | Drug | Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A), Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C), Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B), Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum |
| ZimberelimabAdministered intravenously | Drug | Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C) |
Primary outcome
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
Time frame: First dose date up to 21 days
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.
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities
Time frame: First dose date up to 73 weeks plus 30 days
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.
Phase 2 Cohort 1, Arms A and B: Progression-free Survival (PFS)
Time frame: Up to 129 weeks
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.
Phase 2 Cohort 3: Objective Response Rate (ORR)
Time frame: Up to 129 weeks
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.
11 secondary outcomes
Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab
Time frame: 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
Time frame: Up to end of treatment (up to approximately 73 weeks)
Phase 2 Cohort 1, Arms B and C: Progression-free Survival (PFS)
Time frame: Up to 129 weeks
Phase 2 Cohort 1, Arms A, B and C: Objective Response Rate (ORR)
Time frame: Up to 129 weeks
Phase 2 Cohort 3: Progression-free Survival (PFS)
Time frame: Up to 129 weeks
All Phase 2 Cohorts: Duration of Response (DOR)
Time frame: Up to 129 weeks
All Phase 2 Cohorts: Overall Survival (OS)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 3, Week 6, Week 9, Week 12, Week 15, Week 18, Week 21, Week 24, Week 27 and Week 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundColevas 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.
- BackgroundColevas 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.
- BackgroundColevas 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.
- BackgroundColevas 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.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
88 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magrolimab, Pembrolizumab and Docetaxel in people with Head and Neck Squamous Cell Carcinoma, run by Gilead Sciences at 88 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 88 sites in United States, Spain, France, Australia, Belgium and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: First dose date up to 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04854499, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.