Active not recruitingPHASE2INTERVENTIONAL

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

This study, called ASPEN-04, is for people with advanced head and neck squamous cell carcinoma that has spread or come back and cannot be removed by surgery. Researchers are investigating a new treatment combination: a drug called evorpacept (also known as ALX148) given alongside pembrolizumab and standard chemotherapy (cisplatin/carboplatin and 5FU). The main goal is to see how well this new three-drug combination works compared to pembrolizumab and chemotherapy alone. This is a Phase 2 study, meaning it's still in the earlier stages of testing to determine its effectiveness and safety.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

ALX Oncology Inc.

Enrolment target

172

Start

10 May 2021

Estimated completion

30 Jun 2026

Head and Neck Cancer Head and Neck Squamous Cell Carcinoma

What is this study about?

This study is particularly for people in the UK recently diagnosed with advanced head and neck cancer (specifically squamous cell carcinoma) that has either spread to other parts of the body (metastatic) or has come back after previous treatment and can't be surgically removed (unresectable, recurrent). If you haven't yet received treatment for this advanced stage of your cancer, this study might be relevant.

The study is testing a new drug called evorpacept (sometimes referred to as ALX148). This drug is being combined with two existing treatments: pembrolizumab, which is an immunotherapy that helps your body’s immune system fight cancer, and standard chemotherapy which often involves drugs like cisplatin or carboplatin, and 5FU. The researchers want to understand if adding evorpacept to pembrolizumab and chemotherapy works better than just using pembrolizumab with chemotherapy alone. The ultimate goal is to find more effective ways to treat this type of head and neck cancer.

This is a 'Phase 2' study, which means it's an important step to see if the new combination is likely to be effective and safe enough to be tested further in larger studies. The study starts with a small group to check safety, then expands to compare the different treatment approaches in a larger group of patients. It's designed to gather important information that could potentially lead to improved treatment options for people with advanced head and neck cancer.

Key takeaways

This study is for advanced head and neck cancer that has spread or returned.
It tests a new drug, evorpacept, combined with existing cancer treatments.
The study aims to see if this new combination is more effective than current treatment.
You would be randomly assigned to one of two treatment groups.
Regular hospital visits, tests, and scans would be part of your participation.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

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.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have head and neck squamous cell carcinoma that has spread or returned and cannot be surgically removed?
Have you not yet received any treatment for this advanced stage of your cancer?
Are your bone marrow, kidney, and liver functions generally healthy?
Have you *not* had specific prior immune treatments (anti-CD47, anti-SIRPα, anti-PD-1, or anti-PD-L1)?
Do you *not* have symptomatic brain metastases or a severe lung condition called pneumonitis?

Answer every question to see your result.

What does participation involve?

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.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as access to a new treatment combination that is not yet widely available, and close medical monitoring. However, there are also potential risks; all medications can have side effects, and some may be serious. The study drugs may cause new or unexpected side effects, or those that are more severe than standard treatments. You will be fully informed of all known side effects before you decide to participate. Your safety and well-being are paramount, and you would have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (44)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Hoag Hospital
Verified postcode
Irvine, United States
University of California San Diego
Verified postcode
La Jolla, United States
Cedar Sinai Medical Center
Verified postcode
Los Angeles, United States
University of Miami, Sylvester Comprehensive Cancer Center
Verified postcode
Miami, United States
Moffitt Cancer Center
Verified postcode
Tampa, United States
Rush University Medical Center
Verified postcode
Chicago, United States
University of Louisville
Verified postcode
Louisville, United States
University of Maryland Medical System
Verified postcode
Baltimore, United States
Memorial Sloan Kettering
Verified postcode
New York, United States
The Ohio State University
Verified postcode
Columbus, United States
Oregon Health & Science University/ Knight Cancer Institute
Verified postcode
Portland, United States
Vanderbilt - Ingram Cancer Center
Verified postcode
Nashville, United States

Common questions

What is head and neck squamous cell carcinoma?

It's a common type of cancer that starts in the flat, thin cells lining the moist surfaces inside the head and neck, such as the mouth, throat, or voice box.

What does 'metastatic or unresectable, recurrent' mean?

This means the cancer has spread to other parts of the body (metastatic), or it has come back after previous treatment and cannot be removed by surgery (unresectable, recurrent).

What kind of new drug is evorpacept?

Evorpacept is a type of immunotherapy. It's designed to help your body's immune system recognise and fight cancer cells more effectively.

Will I definitely receive the new drug combination?

No, because this is a randomised study, you will be assigned by chance to either receive the new combination (evorpacept plus pembrolizumab and chemotherapy) or just pembrolizumab and chemotherapy.

What stage is this study in?

This is a Phase 2 study. This means researchers are currently evaluating how effective and safe the new treatment is in a larger group of patients after initial safety tests.