The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with Head and Neck Squamous Cell Carcinoma for a research study. The purpose of the study is to help researchers understand more about the possible effectiveness, tolerability, and safety of amivantamab (also known as JNJ-61186372) in participants with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) when given alone or in addition to standard of care therapeutic agents, paclitaxel or pembrolizumab. Amivantamab for subcutaneous use is considered an investigational drug because it has not yet been approved by the United States Food and Drug Administration (FDA).
The study involves receiving the investigational drug, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, imaging of your tumor, and talking to the study doctor. The study will include a screening period followed by a treatment period with 21 day cycles. The first cycle will have 3 study visits, and subsequent cycles will have 1 visit per cycle. After treatment is complete there will be an end of treatment visit, followed by a safety follow up period where the study team will contact you every 12 weeks to review how you are doing.
The investigational drug, amivantamab, will be provided by the sponsor at no cost to you. Study-required visits, tests, and medication may be provided at no cost. Patients may also be reimbursed for any study-required travel or expenses.
Additional information can be found here: https://clinicaltrials.gov/
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