Active not recruitingPHASE2, PHASE3INTERVENTIONAL

INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC

This research study is investigating a new treatment approach for advanced head and neck squamous cell carcinoma (HNSCC). This type of cancer has spread or come back and can't be treated locally. The study aims to see how safe and effective a new drug called INBRX-106 is when given alongside an existing drug, pembrolizumab. Some participants will receive the combined treatment, while others will receive pembrolizumab with a placebo (a dummy drug). This comparison helps researchers understand if adding INBRX-106 improves treatment. The study is specifically for patients whose cancer shows a certain level of a marker called PD-L1 (CPS ≥20) and who haven't had prior systemic treatment for their advanced cancer. The goal is to find better ways to treat this condition.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Inhibrx Biosciences, Inc

Enrolment target

410

Start

14 May 2024

Estimated completion

01 May 2029

Head and Neck Squamous Cell Carcinoma (HNSCC)

What is this study about?

This study is for people with a type of cancer called head and neck squamous cell carcinoma (HNSCC). This means the cancer has either come back or spread to other parts of the body, and doctors don't believe it can be cured with surgery or radiation.

The main idea behind this study is to explore a new treatment that combines two different medicines: INBRX-106 and pembrolizumab. Pembrolizumab is a type of immunotherapy that works by helping your body's own immune system fight cancer. INBRX-106 is an experimental drug designed to also boost your immune system's attack on cancer cells. Researchers want to see if using these two drugs together is more effective and safe than using pembrolizumab alone, which some patients might receive with a dummy drug (placebo) for comparison.

Taking part in a study like this helps doctors learn more about new ways to treat cancer. It's an important step in finding better treatments for patients in the future. The study will look closely at how well the treatment works and if there are any side effects.

Key takeaways

This study is for advanced head and neck cancer that can't be cured locally.
It tests a new combination of two immune-boosting drugs.
Some patients will get the new combination, others pembrolizumab with a placebo.
Participation involves regular hospital visits for infusions and tests.
Helps researchers find new treatments for this type of cancer.

Who may be eligible?

To join this study, you would need to have head and neck cancer that has spread or returned and cannot be cured by local treatments like surgery or radiation. Your cancer cells must also show a certain level of a marker called PD-L1 (measured by something called a CPS score of 20 or higher) in a tumour sample.

Doctors will also check your general health, including your ability to perform daily activities. You can't have had previous widespread treatments for your advanced cancer, though some earlier treatments for less advanced cancer might be allowed under specific conditions.

There are also some reasons why you might not be able to join. For example, if you have certain other serious health problems, like active cancer in your brain, or if you're taking medicines that suppress your immune system.

Quick self-check

Do I have head and neck cancer that has spread or come back?
Has my doctor said my cancer can't be cured with local treatments?
Have I had a test showing my cancer has a PD-L1 CPS score of 20 or higher?
Have I NOT had other widespread treatments for my advanced cancer recently?
Am I at least 18 years old and generally well enough for a study?

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

What does participation involve?

If you decide to join this study, you'll be assigned to one of the treatment groups by chance, like flipping a coin. You'll receive infusions of the study medicine(s) at regular intervals at the hospital. Doctors will regularly check how you're feeling, conduct physical exams, and take blood samples. You'll also have scans, like CT or MRI, to see how the cancer is responding to treatment.

Throughout the study, you'll have appointments to review your progress and manage any side effects. The total duration of your participation will depend on how you respond to the treatment and the study plan, but it will involve ongoing visits for treatment and monitoring.

Potential risks and benefits

Participating in a clinical trial may offer the potential benefit of access to a new treatment before it's widely available. While we hope the new treatment will be effective, there's no guarantee that it will work for you, or that it will be better than standard treatments. Like all medicines, the study drugs can have side effects, which can range from mild to serious. The research team will explain all known side effects. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (87)

City of Hope Medical Center
Duarte, United States
Los Angeles Cancer Network (LACN)
Los Angeles, United States
UC Davis
Sacramento, United States
Medical Oncology Associates of San Diego
San Diego, United States
Sarcoma Oncology Center
Santa Monica, United States
ChristianaCare Health Services
Newark, United States
University of Florida UF Health Cancer Center
Gainesville, United States
The Oncology Institute of Hope & Innovation
Miami, United States
Mid Florida Hematology and Oncology Center
Orange City, United States
Cleveland Clinic Florida, The Maroone Cancer Center
Weston, United States
University of Illinois Cancer Center
Chicago, United States
Norton Cancer Institute
Louisville, United States

+75 more sites — see the official record for the full list.

Common questions

What is head and neck squamous cell carcinoma?

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

What does 'first-line treatment' mean?

This means it's the first treatment given for a health problem. In this case, it's the first treatment for advanced head and neck cancer.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers compare how well the real drug works.

What is PD-L1 and a CPS score?

PD-L1 is a protein found on some cancer cells. A CPS score helps doctors measure the amount of PD-L1 in your cancer, which can help predict if certain immune therapies might work.

Can I still get other medical care if I join?

Yes, you will continue to receive medical care from your doctors, and the study team will work closely with them.