Frequently Asked Questions

Zanzalintinib (XL092) is a type of drug called a ‍TKI – TKIs are drugs that are designed to block certain signals that help cancer grow. Zanzalintinib is a TKI.‍tyrosine kinase inhibitor (TKI). 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 kidney cancer. Zanzalintinib is a tablet that is taken orally (by mouth). Zanzalintinib is an investigational drug. It is currently being studied as a possible treatment for kidney cancer with papillary, unclassified, and translocation-associated subtypes.

Nivolumab is a different type of drug called an ‍ICI – Immune checkpoint inhibitors are special drugs that help the immune system find and attack cancer cells. They work by taking away a “checkpoint” that cancer cells use to hide from the immune system. This may make the immune system better able to fight cancer. Nivolumab is an ICI.‍immune checkpoint inhibitor (ICI), which is given into your vein (intravenously). ICIs may strengthen the activity of your immune system to recognize and attack cancer cells. Nivolumab is approved by the U.S. Food and Drug Administration (FDA) for use alone and in combination with other medicines for many different types of cancer. Nivolumab in combination with zanzalintinib is not FDA-approved for general use.

Sunitinib is an oral (taken by mouth) ‍TKI – TKIs are drugs that are designed to block certain signals that help cancer grow. Zanzalintinib is a TKI.‍tyrosine kinase inhibitor (TKI) that is approved by the FDA for people with advanced renal cell carcinoma, including non–clear cell renal cell carcinoma.

A clinical trial is a research study. Clinical trials are done for many reasons, including to find new ways to treat a disease or condition. A clinical trial 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 to give to patients. Without people taking part in these studies, we would have no new medicines.

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

• Having access to a potential new treatment that you cannot receive outside of the study
• Being closely monitored by a medical team
• Helping researchers to learn more about cancer to help people in the future

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

You should know that, even if the clinical trial drugs do not work as planned, what is learned may be useful to future patients and researchers. The information learned may help doctors decide how to treat other patients.

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:

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

Study staff will review the document with you, in full, before you sign it and enroll in the clinical trial. This is to make sure that you understand the known risks and that the study drugs 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:

• Check your health
• Change or stop the study drugs if needed or if you aren’t feeling well
• Collect information about your response to the study drugs

3. Taking part in a clinical trial may involve additional visits and tests. This lets study doctors check your safety and how you respond to the study drugs.

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.

If you are thinking about joining a clinical trial as a treatment option, the best way to start is by talking with your doctor. Your doctor can help you decide if a clinical trial could be a good option for you.

To help start that conversation, download the Discussion Guide.

If you decide to take part, you will be in this study for about 7 to 11 months. The length of time may be different for each person and can depend on:

• If the treatment is helping
• If you have any side effects

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.

Clinical trials need participants from many different races, ethnicities, genders, ages, sexual orientations, living conditions, life experiences, and more. Having diverse representation in clinical trials helps show if new medicines are safe and work well for people likely to use the medicines.