The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with metastatic/recurrent head and neck squamous cell carcinoma. The purpose of this study is to compare the anti-tumor activity and the effect on overall survival of the investigational drug petosemtamab against investigator’s choice treatment for the treatment of your cancer. Petosemtamab is investigational because it has not been approved by the United States Food and Drug Administration (FDA). Petosemtamab will be compared against investigator’s choice treatment. If you agree to participate in this study, you will be assigned randomly/by chance (like flipping a coin) to study treatment with petosemtamab (50% chance) or to treatment as selected by your Study Doctor (50% chance).
The study involves receiving the investigational drug or investigator’s choice treatment, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, and talking to the study doctor. If you are eligible for the study and consent to participate, your involvement includes a screening period to check for eligibility for the study. After the screening period you will be randomly assigned to either receiving petosemtamab or investigator’s choice treatment and you will enter the treatment period. During this period treatment cycles last 28 days and you will come in for study visits more than once per cycle, for tests or procedures as well as receiving petosemtamab or the other choice. After your last dose of study treatment you will have a follow-up visit called the End of Study Treatment visit, a Safety Follow-up visit, and a Follow-up period to see how you are doing.
The study drugs, petosemtamab or the assigned investigator’s choice treatment, will be provided by the sponsor at no cost to you. All additional study procedures that are beyond your standard medical care, including laboratory tests, physical examinations, and visits to the study center, are provided to you at no charge.
Additional information can be found here: https://clinicaltrials.gov/
Stipend: $107 Per Visit Hotel Reimbursement: $200 per night