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BMX-HN-001 for Locally Advanced Head and Neck Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to understand how the study drug BMX-001 works to improve the side effects of treatment including sore mouth/throat, skin changes, swallowing difficulties and dry mouth.

What is the Condition Being Studied?

Head and Neck Cancer

Who Can Participate in the Study?

Adults who:
- Are diagnosed with head and neck cancer for whom cisplatin and radiation would be considered appropriate care
- Have a radiation treatment plan that has a daily radiation treatment
- Have a negative pregnancy test

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Have screening tests and procedures such as blood tests, physical exam and imaging
- Get the study drug, BMX-001, as a shot under your skin along with radiation therapy and the chemotherapy drug, cisplatin
- Get the first shot of BMX-001 a couple of days before radiation therapy (RT) starts, and BMX-001 is given for eight weeks
- Be involved in this study for about 1 year

Study Details

Full Title
A Phase 1/2 Trial of Concurrent Radiation Therapy, Cisplatin, and BMX-001 in Locally Advanced Head and Neck Cancer
Principal Investigator
Radiation Oncologist
Protocol Number
IRB:PRO00076742
NCT:NCT02990468
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698