Active not recruitingPHASE2INTERVENTIONAL

Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

This research trial, called ASPEN-03, is investigating a new treatment approach for advanced head and neck squamous cell carcinoma (a type of head and neck cancer). It combines a new drug called evorpacept with an already approved cancer drug, pembrolizumab. The main goal is to find out if this combination therapy is more effective at fighting the cancer than pembrolizumab on its own. This study is for people whose cancer has spread or returned and cannot be removed by surgery, and who have not yet received treatment for this advanced stage of their disease. Researchers will compare patients receiving the new combination with those receiving pembrolizumab only to see which treatment works best. It's a Phase 2 trial, which means it’s still in the early stages of testing for effectiveness and safety. Participants will be aged 18 or older.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

ALX Oncology Inc.

Enrolment target

189

Start

02 Apr 2021

Estimated completion

30 Jun 2026

Head and Neck Cancer Head and Neck Squamous Cell Carcinoma

What is this study about?

This clinical trial is designed for people with a type of head and neck cancer called squamous cell carcinoma, which has either spread to other parts of the body (metastatic) or has come back after treatment and can't be surgically removed (unresectable, recurrent). The study is specifically looking at patients who haven't received any treatment yet for this advanced stage of their cancer.

The main idea behind this study is to test a new drug, evorpacept, when given together with pembrolizumab, which is a common cancer medication. Doctors want to see if this combination works better than pembrolizumab alone in shrinking the cancer or stopping it from growing. Pembrolizumab works by helping your body's immune system fight cancer cells, and evorpacept is designed to help this process even further.

This is a Phase 2 study, which means it's one of the earlier steps in testing new treatments. It focuses on how well the treatment works against the cancer and also continues to check for safety. A small group of patients will first receive the combined treatment to ensure it's safe. After that, more patients will be randomly assigned to either receive the combination treatment or pembrolizumab on its own, so doctors can directly compare the two approaches. This helps researchers understand if adding evorpacept provides a meaningful benefit.

Key takeaways

This study is for advanced head and neck cancer that hasn't been treated yet.
It tests a new drug, evorpacept, combined with an existing one, pembrolizumab.
The goal is to see if the combination works better than pembrolizumab alone.
It's a Phase 2 trial, focusing on effectiveness and safety.
Participants must be 18 or older and meet specific health requirements.

Who may be eligible?

To be able to join this study, you would generally need to have head and neck squamous cell carcinoma that has either spread or come back after previous treatment and can't be removed by surgery. Importantly, you shouldn't have received any other treatments for this advanced stage of your cancer yet. Your cancer also needs to show certain features that indicate it might respond to the treatments being studied.

Your general health is also important. This includes having healthy bone marrow (which makes blood cells), good kidney and liver function, and a good overall physical ability to carry out daily activities. You must be at least 18 years old to participate.

There are also some reasons why you wouldn't be able to join. For example, if your cancer has spread to your brain and is causing severe symptoms, or if you have a history of certain lung problems that needed strong medication. Also, if you've previously been treated with similar types of immune-boosting drugs that are being tested in this trial, you wouldn't be able to take part.

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.

I have advanced head and neck squamous cell carcinoma.
My cancer has spread or returned and cannot be surgically removed.
I have not received any treatment yet for my advanced cancer.
I am at least 18 years old.
My general health, including blood, kidney, and liver function, is considered good by my doctor.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first go through some screening tests to see if the study is right for you. If you qualify, you'll be randomly assigned to one of two groups: either you'll receive the new drug evorpacept plus pembrolizumab, or you'll receive pembrolizumab alone. This is like flipping a coin – neither you nor the doctors decide which group you're in, which helps make the study fair.

The treatments will be given through injections or infusions, typically at a clinic or hospital. You'll have regular visits for blood tests, physical exams, and scans (like CT or MRI) to check how you're responding to the treatment and to monitor for any side effects. The study involves ongoing treatment and visits as long as the treatment is working and you are tolerating it well. After you stop treatment, there will be follow-up visits or calls to monitor your health over a longer period. The total duration of your involvement could vary depending on your response to treatment and the follow-up schedule.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to new treatments before they are widely available, and close monitoring by a medical team. For this study, there's a chance the combination treatment might be more effective than standard care for your type of cancer. However, there are also potential risks; new drugs can have side effects that aren't fully known, and some treatments might not work for everyone. You might experience side effects from either evorpacept or pembrolizumab, or a combination of both. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (53)

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
H. Lee Moffitt Cancer Center
Verified postcode
Tampa, United States
Northwest Georgia Oncology Centers
Verified postcode
Marietta, United States
Rush University Medical Center
Verified postcode
Chicago, United States
Blessing Cancer Center
Verified postcode
Quincy, United States
University of Maryland Medical System
Verified postcode
Baltimore, United States
Massachusetts General Hospital
Verified postcode
Boston, United States
Rutgers Cancer Institute of New Jersey
Verified postcode
Newark, United States
Memorial Sloan-Kettering Cancer Center
Verified postcode
Long Island City, United States
The Ohio State University
Verified postcode
Columbus, United States
Oregon Health & Science University
Verified postcode
Portland, United States

Common questions

What is head and neck squamous cell carcinoma?

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

What does 'advanced' cancer mean in this study?

It means the cancer has either spread to other parts of your body or has returned after initial treatment and cannot be removed by surgery.

What is the new drug, evorpacept?

Evorpacept is a new investigational drug designed to help your immune system recognise and fight cancer cells more effectively when used with other treatments.

What is pembrolizumab?

Pembrolizumab is an approved medication that works by helping your body's own immune system find and kill cancer cells. It's often used for certain advanced cancers.

What does 'Phase 2' trial mean?

Phase 2 means the study is in an earlier stage of testing, mainly focused on seeing if the treatment works well against the cancer and continuing to check for safety.