Active not recruitingPHASE2, PHASE3INTERVENTIONAL

Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This study is looking for people with a type of head and neck cancer called squamous cell carcinoma that has either returned or spread to other parts of the body, and can't be cured by standard local treatments. Participants will be randomly assigned to one of two groups. One group will receive two medications: zanzalintinib and pembrolizumab. The other group will receive pembrolizumab along with a 'dummy' drug (placebo) that looks like zanzalintinib. This helps researchers understand if adding zanzalintinib makes a difference. The aim is to see if the combination of zanzalintinib and pembrolizumab is more effective for people whose cancer shows a specific marker called PD-L1.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Exelixis

Enrolment target

600

Start

07 Jun 2024

Estimated completion

01 Mar 2029

Head and Neck Squamous Cell Carcinoma

What is this study about?

This research study is about finding better ways to treat head and neck squamous cell carcinoma. This is a type of cancer that starts in the flat cells lining parts of your head and neck, like your mouth, throat, or voice box. The study is for people whose cancer has either come back or spread, and can't be treated with surgery or radiation as a cure.

The study wants to find out if combining a new medication called zanzalintinib with a drug already used for some cancers, called pembrolizumab, works better than pembrolizumab alone. Pembrolizumab helps your own immune system fight cancer. Zanzalintinib works differently, by blocking certain signals inside cancer cells that help them grow and spread.

Participants in this study will be split into two groups by chance – a bit like flipping a coin. One group will get zanzalintinib along with pembrolizumab. The other group will get pembrolizumab and a 'placebo' – a dummy pill that looks just like zanzalintinib but has no active drug. This 'double-blind' approach means neither you nor your doctors will know which treatment you are receiving, which helps make the study results fair and clear.

Key takeaways

This study evaluates a new drug combination for head and neck cancer.
It's for cancer that has returned or spread and can't be cured locally.
You'll receive either the new combination or a standard drug plus a dummy pill.
The study is 'double-blind,' meaning neither you nor your doctor will know which treatment you are getting.
Your cancer must show a specific marker called PD-L1.

Who may be eligible?

This study is looking for adults aged 18 or older with head and neck squamous cell carcinoma that has returned or spread and cannot be cured by local treatments like surgery or radiation. You must not have had other treatments for your recurrent or metastatic cancer before, although some past treatments for earlier stages of your cancer might be allowed if they finished a while ago. Your cancer also needs to show a specific marker called PD-L1.

There are some reasons why you might not be able to join. For example, if your cancer started in your nose or salivary glands, or if it could still be cured by surgery or radiation. You also can't have received certain types of cancer treatments in the past, including zanzalintinib or similar immune-boosting drugs like pembrolizumab. If your doctors think you have less than 3 months to live, or if you've recently had other treatments for cancer that didn't work, you might not be eligible.

Quick self-check

Are you 18 years old or older?
Do you have head and neck squamous cell carcinoma that has come back or spread?
Has your doctor told you that your cancer shows the PD-L1 marker (Combined Positive Score of 1 or more)?
Have you NOT had any previous drug treatments for your cancer that has spread or returned?
Is your general health good enough to participate (e.g., active and able to perform daily tasks)?
Are your heart, kidney, and liver functions generally healthy enough for treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you will be randomly assigned to one of two groups and receive either zanzalintinib plus pembrolizumab, or a placebo (dummy pill) plus pembrolizumab. You will have regular appointments for check-ups, blood tests, and scans to monitor your health and how your cancer is responding. The duration of your participation will depend on how you respond to the treatment and your overall health, but involves ongoing visits for as long as the treatment is beneficial and you are tolerating it well. There will also be follow-up assessments after you stop treatment to track your progress.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might benefit from a new treatment combination that could be more effective than current standard options, but there's no guarantee. There may also be side effects from the study drugs, some of which could be serious. All potential side effects will be carefully explained by the study team. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (168)

Exelixis Clinical Site #2
Fullerton, United States
Exelixis Clinical Site #1
Orange City, United States
Exelixis Clinical Site #163
Tampa, United States
Exelixis Clinical Site #123
Athens, United States
Exelixis Clinical Site #82
Atlanta, United States
Exelixis Clinical Site #19
Chicago, United States
Exelixis Clinical Site #62
Des Moines, United States
Exelixis Clinical Site #100
Iowa City, United States
Exelixis Clinical Site #4
St Louis, United States
Exelixis Clinical Site #148
Lebanon, United States
Exelixis Clinical Site #158
Camden, United States
Exelixis Clinical Site #3
Shirley, United States

+156 more sites — see the official record for the full list.

Common questions

What is PD-L1?

PD-L1 is a protein found on some cancer cells. It helps the cancer hide from your immune system. Treatments that target PD-L1 help your immune system find and fight the cancer.

What does 'randomized' mean?

It means you'll be assigned to one of the treatment groups by chance, like drawing lots or flipping a coin. This ensures the study is fair.

What is a 'placebo'?

A placebo is a 'dummy' drug that looks like the real treatment but contains no active medicine. It helps researchers understand if the active drug is truly making a difference.

Can I still receive other cancer treatments while in the study?

Generally no, you cannot receive other systemic cancer treatments while in the study. The study drugs must be the only active treatments for your cancer to assess their effects accurately.

How long will I be in the study?

Your time in the study will vary, depending on how you respond to the treatment and your health. You will continue treatment as long as it is helping and you are tolerating it well, followed by a period of monitoring.