About the study - Head and Neck Squamous Cell Carcinoma (HNSCC) | UniSC | University of the Sunshine Coast, Queensland, Australia

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About the study - Head and Neck Squamous Cell Carcinoma (HNSCC)

Thank you for registering your interest in our Head and Neck Squamous Cell Carcinoma (HNSCC) study. A member of the research team will be in touch within 2 business days to go through the study with you.

What is the study for?

This study is evaluating magrolimab in combination with pembrolizumab only, or with pembrolizumab + 5-FU + platinum chemotherapy, in participants with untreated metastatic HNSCC. Magrolimab will also be evaluated in combination with docetaxel in participants with metastatic HNSCC who have received prior treatment.

What's involved?

This study is split into two phases, the initial phase is to confirm a safe dose of the trial medication. The second phase will evaluate the effectiveness of the trial medication.

For participants considered for the study, you will attend the clinic for a screening visit.

Study treatment will be given in 21-day (3 week) cycles. You will be required to visit the clinic the following number of times while on treatment:
• Cycle 1: 4 times
• Cycle 2: 3 times
• Cycle 3 and beyond: 1 time per cycle until you stop study treatment

After completing treatment, you will be required to visit the clinic for:

• End of treatment visit: 1 time
• Safety follow up visit: You will receive a phone call to check your status and to assess if you need to return to the clinic, If you are experiencing side effects. This may be only 1 time but could be more than once if your study doctor decides it is necessary to monitor the side effect(s) until it resolves or becomes stable.

This is a phase 2 open-label study. Open-label means you and your study doctor will know what study drug you will be taking. Your study doctor will inform you which cohort you are enrolled into.

The research team will sit down with you and go through the study criteria, as well as your medical history, current and past medications and vaccinations. There will be some blood tests and medical examinations to help determine your eligibility for the study.

You will be required to present a valid form of ID at each visit.

All study procedures are at no cost to you, and you will be reimbursed for your time and travel expenses.

Where can I find more information?

More information can be requested by contacting the research site to the right. Alternatively, the research team will be more than happy to answer any questions you may have when they call.

You can also find more study information on the clinical trials database, ClinicalTrials.gov
HREC approval: Alfred Hospital HREC