Frequently Asked Questions

Zanzalintinib is a type of drug called a tyrosine kinase inhibitor (TKI). Zanzalintinib is a pill that is taken orally (by mouth) every day. TKIs such as zanzalintinib may reduce or stop signals that tell cells to grow, divide, and spread. By blocking these signals, TKIs may slow the growth of tumors in people with some types of cancer like head and neck cancers. Zanzalintinib is an investigational drug that is not approved by the U.S. Food and Drug Administration (FDA), and it is currently being studied as a possible treatment for advanced or metastatic head and neck cancers.

Pembrolizumab is a different type of drug called an immune checkpoint inhibitor (ICI), which is given intravenously (into your vein). This is given at the study site once every 3 weeks. ICIs may strengthen the activity of your immune system to recognize and attack cancer cells. Pembrolizumab is approved by the FDA for use alone and in combination with other medicines for many different types of cancer. Pembrolizumab in combination with zanzalintinib is not FDA approved for any use and is the subject of ongoing clinical trials.

A clinical research study is also sometimes called a clinical trial. Research studies are done for many reasons, including to find new ways to treat a disease or condition. A research study helps to answer important questions about a medicine that is still being tested, such as:

• Does it work?
• What amount, or dose, may work best?
• How safe is it?
• Are there side effects?

All medicines must be tested in clinical research studies before they can be approved for the general public. Without people taking part in these studies, we would have no new approved medicines.

Some possible benefits of taking part in a research study may include:

• Having access to study drug(s) that you cannot receive outside of the study
• Helping researchers learn more about cancer to help people in the future

Clinical research studies should include all kinds of people. Certain conditions and medicines may affect people differently based on their age, sex, gender, and race/ethnicity.

You should know that, even if the study drugs do not work as planned, what is learned may be useful to future participants and researchers. The information learned may help doctors decide how to treat other people with this type of cancer.

Talk to your doctor to find out more about the risks involved with taking part in this trial.

1. Volunteering for a study is a personal choice. If you are eligible to join the trial, you will be given an informed consent document. It describes the study and provides important information such as:

• Your rights as a participant
• What taking part in the study will look like for you
• Any potential risks

Study staff will review the full document with you before you sign it and enroll in the research study. The study staff want to make sure that you understand the known risks of the study drugs and that they may or may not work how researchers think they will. Sometimes there are unexpected problems, including serious side effects.

2. A healthcare team will take care of you during the trial. They will give you specific instructions to follow while you take part in the trial. Your healthcare team will also:

• Monitor your health
• Track how you respond to the study drugs
• Change or stop the study drugs if needed or if you are not feeling well

3. Taking part in a research study may involve additional visits and tests. This lets study doctors check how you respond to the study drugs and if there are any safety concerns.

4. There is a risk of side effects. Ask your trial doctor for more information.

5. You can choose to leave the study at any time. If you decide to leave the study, your doctor will discuss other treatment options with you.

6. After the study is done, you will be able to see results from the study. Results from the study will be posted on ClinicalTrials.gov. Your study results will not be shared through this website, but you can get your results from your study doctor.