RecruitingPHASE2INTERVENTIONAL

Molecular Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC

This clinical trial is for people with advanced head and neck cancer. After standard treatments like surgery, radiation, or chemotherapy, some patients might still have tiny traces of cancer DNA in their blood (called molecular residual disease or MRD). This study is testing a new drug, AZD2936, to see if it can clear these remaining cancer traces. Researchers want to find out if reducing MRD in the blood can improve patient outcomes. About 100 patients are expected to take part. This trial will help us understand if targeting these small traces of cancer can prevent the cancer from coming back.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University Health Network, Toronto

Enrolment target

102

Start

12 Jul 2023

Estimated completion

01 Jul 2028

Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

What is this study about?

This study is about a type of cancer called Head and Neck Squamous Cell Carcinoma (HNSCC). This is a cancer that starts in the moist, protective linings of the head and neck, such as the mouth, throat, or voice box. The trial is focusing on patients whose HNSCC is considered "locoregionally advanced," meaning it has grown into nearby tissues but hasn't spread to distant parts of the body yet. After patients receive their usual main treatments, like surgery, radiotherapy, or chemotherapy, doctors will check their blood for very small amounts of cancer DNA. If these traces are found, it's called "molecular residual disease" (MRD).

The main goal of this study is to test a new medicine, AZD2936, in patients who still have MRD after their initial treatments. The researchers want to see if this new drug can help get rid of these remaining cancer traces. They also want to understand if successfully clearing MRD leads to better long-term health outcomes for patients. This is a "Phase II" study, which means it's testing if the drug works and is safe in a larger group of people after initial safety checks.

By participating, patients would help doctors learn more about the best ways to treat head and neck cancer and how to stop it from returning. Understanding how to tackle MRD could be a big step forward in making treatments more effective for people with this type of cancer.

Key takeaways

This study is for advanced head and neck cancer.
It aims to clear tiny cancer traces (MRD) in the blood after initial treatment.
A new drug, AZD2936, is being tested.
About 100 patients will participate.
Participation involves blood tests, scans, and potential new medication.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be 18 years or older and generally well enough to take part, meaning you can carry out most of your daily activities without much trouble. You need to have been diagnosed with advanced head and neck cancer (specifically HNSCC) that has not spread far in your body. This includes certain types of HPV-positive and HPV-negative cancers. You also need to be a candidate for standard cancer treatments like surgery, radiation, or chemotherapy.

Specifically for the treatment part of the study (Part C), you must have signs of cancer DNA (MRD) in your blood tests after your main treatments. Your general health must still be good, and your tumour needs to show certain features when tested (PD-L1 positive). The doctors will explain all these details to make sure you meet the specific requirements for each stage of the study.

The research team will review your medical history and test results to confirm if you are suitable. It's important to remember that not everyone with head and neck cancer will be able to join, as the study has very specific criteria designed to ensure patient safety and get the clearest results possible.

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.

Am I 18 years old or older?
Do I have advanced head and neck cancer (HNSCC)?
Am I generally well enough to go about my daily activities?
Have I had or am I about to have standard cancer treatment for my condition?
Will I be able to provide old tumour samples for testing?
Am I able to attend regular appointments for tests and check-ups?

Answer every question to see your result.

What does participation involve?

If you join this study, it's divided into several parts. Everyone starts with Part A and B. Part A is when you receive your usual, standard cancer treatment (surgery, radiation, or chemoradiation). During Part B, after your initial treatment, you'll have blood tests (specifically looking for cancer DNA, called ctDNA) at around 5 weeks, 10 weeks, 26 weeks, and 52 weeks to see if any cancer traces remain. If you have surgery, you'll also have a ctDNA test after that.

If cancer traces are found in your blood during Part B, you might be invited to Part C, where you would receive the study drug, AZD2936. This treatment would continue for up to 6 cycles, or until side effects become too difficult, or if you decide to stop. During Part C, you'll have another blood test at around 10 weeks. After Part C, you'll enter Part D for follow-up, which includes further blood tests over several months. If you don't have cancer traces in your blood after Part B, you'll enter Part E for observation and longer-term follow-up.

Throughout the study, you'll have various check-ups, scans (like CT or MRI), and blood samples taken at different times as planned by the research team. The total duration of your involvement can vary depending on which parts of the study you participate in and how long you remain on treatment or in follow-up.

Potential risks and benefits

Taking part in a clinical trial can offer potential benefits, such as receiving a new treatment that might be more effective than existing options, especially if you have cancer traces remaining after initial treatment. You'll also receive very close medical monitoring. However, there are potential risks, as the new drug AZD2936 might have side effects that aren't fully known yet. You might also need more doctor visits and tests than if you weren't in the study. It's very important to know that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is 'molecular residual disease' (MRD)?

MRD means small, tiny pieces of cancer DNA are still found in your blood after your main cancer treatment.

What is AZD2936?

AZD2936 is a new drug being tested in this study to see if it can help clear those remaining cancer traces in the blood.

How many people will be in this study?

Around 100 patients are expected to take part in this research.

Will I still get my usual cancer treatment?

Yes, everyone in the study will receive their standard cancer treatment first, before potentially receiving the study drug if they have MRD.

What if I decide I don't want to continue in the study?

You can leave the study at any time, for any reason, without it affecting the care you receive from your doctors.

How to find out more

Lillian Siu, MD

tip@uhn.ca 416-946-4501 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.