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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04854499
Registration number
NCT04854499
Ethics application status
Date submitted
19/04/2021
Date registered
22/04/2021
Titles & IDs
Public title
Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
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Scientific title
A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
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Secondary ID [1]
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2020-005708-20
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Secondary ID [2]
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GS-US-548-5916
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Universal Trial Number (UTN)
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Trial acronym
ELEVATE HNSCC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Head and neck
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Magrolimab
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Docetaxel
Treatment: Drugs - 5-FU
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Zimberelimab
Experimental: Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum - Participants with untreated metastatic or unresectable, locally recurrent head and neck squamous cell carcinoma (HNSCC) regardless of programmed cell death ligand 1 (PD-L1) status will receive the following:
* magrolimab
* 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.
Experimental: Safety Run-in Cohort 2, Magrolimab + Docetaxel - Participants with locally advanced/metastatic HNSCC regardless of PD-L1 status who were previously treated with at least 1 and no more than 2 lines of prior systemic therapy will receive the following:
* magrolimab
* 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.
Experimental: Pre-expansion Safety Run-in Cohort, Magrolimab + Pembrolizumab - The pre-expansion safety run-in cohort may be conducted at the sponsor's discretion prior to the initiation of Phase 2 Cohort 2.
Participants with untreated metastatic or unresectable, locally recurrent HNSCC with a PD-L1 combined positive score (CPS) = 1 will receive magrolimab and pembrolizumab 200 mg on Day 1 of each cycle. Each cycle is 21 days.
Participants will continue treatment until unacceptable toxicity or disease progression, whichever occurs first, and will not change their magrolimab dose level after the RP2D is determined. Each cycle is 21 days.
Experimental: Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A) - Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety run-in cohort 1, pembrolizumab 200 mg on Day 1 of each cycle, 5-FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days.
Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first.
Active comparator: Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B) - Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive pembrolizumab 200 mg on Day 1 of each cycle, 5-FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days.
Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first.
Experimental: Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C) - Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety run-in cohort 1, zimberelimab 360 mg on Day 1 of each cycle, 5-FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days.
Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Zimberelimab therapy will be administered up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first.
Experimental: Phase 2 Cohort 2, Magrolimab + Pembrolizumab - Participants with untreated metastatic or unresectable, locally recurrent HNSCC with a PD-L1 combined positive score (CPS) = 1 will receive magrolimab at the RP2D determined in the Safety run-in cohort 1 and pembrolizumab 200 mg on Day 1 of each cycle. Each cycle is 21 days.
Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first.
Experimental: Phase 2 Cohort 3, Magrolimab + Docetaxel - Participants with locally advanced/metastatic HNSCC regardless of PD-L1 status who were previously treated with at least 1 and no more than 2 lines of prior systemic therapy will receive magrolimab at the RP2D determined in the Safety run-in cohort 2 and docetaxel 75 mg/m\^2 on Day 1 of each cycle. Each cycle is 21 days.
Magrolimab and docetaxel will be continued until loss of clinical benefit, unacceptable toxicity, or death.
Treatment: Drugs: Magrolimab
Administered intravenously
Treatment: Drugs: Pembrolizumab
Administered intravenously
Treatment: Drugs: Docetaxel
Administered intravenously
Treatment: Drugs: 5-FU
Administered intravenously
Treatment: Drugs: Cisplatin
Administered intravenously
Treatment: Drugs: Carboplatin
Administered intravenously
Treatment: Drugs: Zimberelimab
Administered intravenously
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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First Dose up to 21 days
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Primary outcome [2]
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Phase 2 Cohorts 1: Progression-free Survival (PFS)
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Assessment method [2]
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PFS is defined as the time from the date of randomization until the earliest date of documented disease progression, as assessed by investigator assessment, or death from any cause, whichever occurs first.
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Timepoint [2]
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Up to 5 years
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Primary outcome [3]
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Phase 2 Cohorts 2 and 3: Objective Response Rate (ORR)
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 9 months
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Secondary outcome [1]
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Safety Run-In and Phase 2 Cohorts: Serum Concentration of Magrolimab
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Assessment method [1]
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0
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Timepoint [1]
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Up to end of treatment (approximately 24 months)
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Secondary outcome [2]
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Safety Run-In and Phase 2 Cohorts: Percentage of Participants who Developed Antidrug Antibodies (ADAs) to Magrolimab
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Assessment method [2]
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0
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Timepoint [2]
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0
Up to end of treatment (approximately 24 months)
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Secondary outcome [3]
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Phase 2 Cohorts: Objective Response Rate (ORR)
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Assessment method [3]
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ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as determined by investigator assessment.
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Timepoint [3]
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Up to 9 months
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Secondary outcome [4]
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Phase 2 Cohorts: Progression-free Survival (PFS)
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 5 years
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Secondary outcome [5]
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Phase 2 Cohorts: Duration of Response (DOR)
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Assessment method [5]
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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.
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Timepoint [5]
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Up to 5 years
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Secondary outcome [6]
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Phase 2 Cohorts: Overall Survival (OS)
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Assessment method [6]
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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.
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Timepoint [6]
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Up to 5 years
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Secondary outcome [7]
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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
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Assessment method [7]
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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).
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Timepoint [7]
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Baseline; up to 24 months
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Secondary outcome [8]
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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)
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline; up to 24 months
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Secondary outcome [9]
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Phase 2 Cohorts: Change From Baseline in the 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L)
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline; up to 24 months
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Eligibility
Key inclusion criteria
Key
* 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Active central nervous system (CNS) disease (individuals with asymptomatic and stable, treated CNS lesions who have been off corticosteroids, radiation, or other CNS-directed therapy for at least 4 weeks are not considered active).
* History of (noninfectious) pneumonitis that required steroids or current pneumonitis.
* Progressive disease within 6 months of completion of curatively intended treatment for locally advanced/mHNSCC.
Safety Run-in Cohort 1, Pre-expansion Safety Run-in Cohort for Magrolimab + Pembrolizumab (if Applicable), and Phase 2 Cohorts 1 and 2
* Prior treatment with any of the following:
* Anti-programmed cell death protein 1 or anti-PD-L1 checkpoint inhibitors.
* Anti-cytotoxic T-lymphocyte-associated protein 4 checkpoint inhibitors.
Safety Run-in Cohort 2 and Phase 2 Cohort 3
* Prior treatment with a taxane.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/09/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2025
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Actual
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Sample size
Target
230
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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St. Vincent's Hospital Sydney - Darlinghurst
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Macquarie University - Macquarie Park
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Blacktown Hospital - Westmead
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Cairns Hospital - Cairns
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University of the Sunshine Coast - Sippy Downs
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Princess Alexandra Hospital - Woolloongabba
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Austin Health - Heidelberg
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Alfred Health - Melbourne
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2010 - Darlinghurst
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2109 - Macquarie Park
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2145 - Westmead
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4870 - Cairns
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4556 - Sippy Downs
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4102 - Woolloongabba
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3084 - Heidelberg
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Recruitment postcode(s) [8]
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3004 - Melbourne
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Recruitment outside Australia
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Taunton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Ethics approval
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT04854499
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Gilead Study Director
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Gilead Sciences
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04854499