Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)

To be considered for this study, you would need to have head and neck squamous cell carcinoma that has either spread or returned and cannot be operated on. Importantly, you must not have received any previous treatment for this advanced stage of your cancer. Your general health would be assessed to make sure your bone marrow, kidneys, and liver are working adequately, and that your overall physical condition is suitable for you to take part.

There are also some reasons why you might not be able to join. For example, if your cancer has spread to your brain or the lining of your brain and spinal cord, and you're experiencing symptoms that require steroids, you would likely not be eligible. Also, if you have a history of a lung condition called pneumonitis that required steroid treatment, or currently have it, you wouldn't be able to participate. Finally, if you've previously had treatment with specific types of immune-system-affecting drugs, like those that target CD47, SIRPα, PD-1, or PD-L1, you would not be able to join this study.

If you decide to take part, you would be randomly assigned to one of two treatment groups. One group will receive the new drug evorpacept along with pembrolizumab and chemotherapy. The other group will receive pembrolizumab and chemotherapy alone. This is done by chance, like flipping a coin, so neither you nor your doctor can choose which group you are in. You would have regular hospital visits for treatments, check-ups, blood tests, and scans to monitor your health and how the treatment is working. Doctors and study staff will carefully explain the schedule of visits, which may vary depending on the treatment cycle. The total duration of your participation would depend on how your body responds to the treatment and your general health, but you would have ongoing support and monitoring throughout the study and for a period afterwards.