Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma (ELEVATE HNSCC)
G
Greg Durm, MD
Primary Investigator
Overview
What is this study about?
The goals of this clinical study are to learn about the safety, tolerability, dosing andveness of the study drug, magrolimab in combination with other anticancer therapies inwith head and neck squamous cell carcinoma (HNSCC).
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Head and Neck Squamous Cell Carcinoma
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Age: Between 18 Years - 100 N/A
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Gender: All
Key Inclusion Criteria:
- Histologically or cytologically confirmed metastatic or locally recurrent HNSCC thatdered 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 metastaticg.
- Eligible primary tumor locations include oropharynx, oral cavity, hypopharynx, andynx. 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-L1us with at least 1 and no more than 2 lines of prior systemic anticancer therapyhe locally advanced/metastatic setting
Key Exclusion Criteria:
- Active central nervous system (CNS) disease (individuals with asymptomatic and stable,d CNS lesions who have been off corticosteroids, radiation, or otherCNS-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 2Prior treatment with any of the following:Anti-programmed cell death protein 1 or anti-PD-L1 checkpoint inhibitorsAnti-cytotoxic T-lymphocyte-associated protein 4 checkpoint inhibitorsy Run-in Cohort 2 and Phase 2 Cohort 3Progressive disease within 6 months of completion of curatively intended systemicy advanced/mHNSCCPrior treatment with a taxane: Other protocol defined Inclusion/Exclusion criteria may apply.
Updated on
27 Apr 2024.
Study ID: GS-US-548-5916
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