Active not recruitingPHASE2INTERVENTIONAL

SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma

This study is for people with head and neck cancer that has come back in the same area or who have developed a new head and neck cancer. We are investigating whether combining a targeted radiation therapy called SBRT with a drug named pembrolizumab can improve treatment outcomes. Pembrolizumab is an immunotherapy drug that helps your body’s immune system fight cancer. The study will first check for safety and then compare how well patients do with SBRT alone versus SBRT plus pembrolizumab. The main goal is to see if adding pembrolizumab can help keep the cancer from growing or spreading for longer.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

RTOG Foundation, Inc.

Enrolment target

Start

14 Nov 2018

Estimated completion

01 Jul 2029

Head and Neck Squamous Cell Carcinoma (HNSCC)

What is this study about?

Imagine your body's immune system as a strong security force meant to protect you from invaders. Sometimes, cancer cells can hide from this security force. Pembrolizumab is a type of medicine called immunotherapy, which acts like a spotlight, helping your immune system to 'see' and attack the cancer cells more effectively. In this study, we're combining pembrolizumab with a powerful and precise form of radiation therapy called Stereotactic Body Radiation Therapy (SBRT). SBRT delivers high doses of radiation directly to the tumour, aiming to destroy cancer cells with minimal damage to healthy tissue nearby.

The main idea behind this study is to see if these two treatments, when used together, can be more effective than SBRT alone for certain types of head and neck cancer. We're looking at cancer that has come back in the same general area after previous treatment, or a brand new second cancer in the head and neck region. This is a 'Phase 2' study, which means we're evaluating both the safety of this new combination and whether it shows promise in preventing the cancer from growing or returning for longer periods.

By carefully comparing the results of patients who receive SBRT alone with those who receive SBRT plus pembrolizumab, we hope to learn if this combined approach offers a better chance of keeping the cancer under control. Your participation could help us find new and better ways to treat head and neck cancer for future patients.

Key takeaways

This study combines targeted radiation (SBRT) with an immune-boosting drug (pembrolizumab).
It's for head and neck cancer that has returned or is a new primary, and can't be well treated with surgery.
The goal is to see if the combination keeps cancer from growing for longer.
You might receive SBRT alone or SBRT plus pembrolizumab.
If your cancer progresses on SBRT alone, you may then receive pembrolizumab.
Participation involves treatment over weeks/months, followed by follow-up checks.

Who may be eligible?

This study is designed for adults (18 years or older) with head and neck cancer that has either returned in the same general area or is a new cancer in the head and neck. Importantly, your cancer must be a type that doctors don't believe can be fully removed by surgery, or if surgery would cause too many complications or major changes to your body, such as needing to remove your entire tongue or voice box.

You would not be eligible if your cancer *could* be removed by a simpler surgery that wouldn't lead to such major complications. We also check details like your previous radiation treatments and the specific type of head and neck cancer you have, including whether a certain protein called p16 is present. These details help us make sure the study treatments are appropriate and safe for you.

If you're unsure if you meet these criteria, your doctor can discuss the specifics with the study team.

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.

Have you been diagnosed with head and neck squamous cell carcinoma that has come back or is a new primary?
Do doctors think surgery is not the best option for your cancer, or would cause high risks/major changes?
Are you 18 years old or older?
Have you had previous radiation treatment to your head and neck?
Are you able to attend regular appointments for treatment and follow-up?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step is a 'safety run-in' phase. All patients in this phase will receive SBRT radiation therapy over two weeks, followed by pembrolizumab given every three weeks for up to two years. Following this, for the main part of the study, you would be randomly assigned to one of two groups, like flipping a coin, so neither you nor your doctor can choose. One group would receive SBRT over two weeks, then pembrolizumab every three weeks for up to two years. The other group would receive SBRT over two weeks only. If the cancer in this second group starts to grow again within two years, those patients would then be offered pembrolizumab for up to two years.

After your treatment finishes, we would continue to check in with you every six months for three years to see how you are doing. The total duration of active treatment for some may be up to two years, with follow-up beyond that.

Potential risks and benefits

Participating in this study might offer a potential benefit: the combination of SBRT and pembrolizumab could be more effective in controlling your cancer compared to SBRT alone, potentially leading to a longer period without cancer growth. However, there are also potential risks. Both SBRT and pembrolizumab can have side effects. SBRT might cause redness, soreness, or swelling in the treated area, while pembrolizumab, as an immunotherapy, can sometimes cause your immune system to become overactive and affect healthy organs, leading to various side effects. All potential side effects would be fully explained by the study team. You are free to withdraw from the study at any time without explaining why, and it will not affect your future medical care.

Locations (18)

University of Arizona Cancer Center - North Campus
Verified postcode
Tucson, United States
Moffitt Cancer Center
Verified postcode
Tampa, United States
Cleveland Clinic - Weston
Verified postcode
Weston, United States
University of Louisville, James Graham Brown Cancer Center
Verified postcode
Louisville, United States
Boston Medical Center
Verified postcode
Boston, United States
Washington University St. Louis
Verified postcode
St Louis, United States
Northwell Health
Verified postcode
Lake Success, United States
University of Cincinnati Cancer Center - UC Medical Center
Verified postcode
Cincinnati, United States
Cleveland Clinic
Verified postcode
Cleveland, United States
Ohio State University
Verified postcode
Columbus, United States
Penn State Milton S. Hershey Medical Center
Verified postcode
Hershey, United States
Fox Chase Cancer Center
Verified postcode
Philadelphia, United States

Common questions

What is head and neck squamous cell carcinoma?

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

What is SBRT?

SBRT is a special type of radiation therapy that delivers very precise, high doses of radiation to the tumour, typically over a shorter time, to minimise damage to healthy surrounding tissues.

What is pembrolizumab?

Pembrolizumab is a drug that helps your body's immune system recognise and fight cancer cells more effectively. It's often called immunotherapy.

Why is this study being done?

Doctors want to find out if combining SBRT with pembrolizumab is a better way to treat recurrent or new head and neck cancer than SBRT alone, hoping to keep the cancer under control for longer.

Can I choose which treatment I receive?

No, if you enter the main part of the study, a computer will randomly assign you to one of the two treatment groups. This helps make the study fair and unbiased.