Active not recruitingPHASE3INTERVENTIONAL

A Trial Evaluating the Addition of Nivolumab to Cisplatin-RT for Treatment of Cancers of the Head and Neck

This research trial is for people who have had surgery for head and neck cancer that is considered high-risk for returning. The study aims to find out if adding a drug called nivolumab to the usual post-surgery treatment (cisplatin and radiotherapy) is more effective than the usual treatment alone. We want to see if the combined treatment can help people stay cancer-free for longer. Participants will be split into two groups by chance: one group will receive the standard treatment, and the other will receive the standard treatment plus nivolumab. The main goal is to compare how long people in each group remain free of cancer. This study is trying to confirm if the new combination is better at preventing the cancer's return without causing too many extra side effects.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Enrolment target

680

Start

10 Oct 2018

Estimated completion

01 Sep 2027

Squamous Cell Carcinoma of Head and Neck

What is this study about?

This study is about a type of cancer that affects the head and neck area. If you've had surgery for this kind of cancer, and your doctors believe there's a higher chance of it coming back, this study might be for you. We're looking at ways to improve the standard treatment you would normally receive after surgery, which involves a chemotherapy drug called cisplatin and radiotherapy.

The new treatment we're testing involves adding another medicine called nivolumab to this standard care. Nivolumab is a type of immunotherapy, which works by helping your body's own immune system fight cancer cells. The main question we want to answer is whether adding nivolumab helps people stay free of cancer for longer than with the standard treatment alone. We also want to make sure that adding nivolumab doesn't cause too many extra side effects.

To find this out, people taking part will be put into one of two groups by chance – like flipping a coin. One group will get the usual treatment after surgery (cisplatin and radiotherapy). The other group will get the usual treatment plus nivolumab. We'll then carefully follow both groups to see how they respond and how long they remain free of cancer. This will help us understand if this new combination could be a better way to treat head and neck cancer in the future.

Key takeaways

This study evaluates adding nivolumab to standard head and neck cancer treatment.
It aims to see if the new combination prevents cancer recurrence more effectively.
Participation involves receiving either standard treatment or standard plus nivolumab.
The study focuses on high-risk head and neck cancer patients after surgery.
All participants will be closely monitored for treatment effects and side effects.

Who may be eligible?

To join this study, you need to be between 18 and 74 years old. You must have been diagnosed with a specific type of head and neck cancer (squamous cell carcinoma) and have recently had surgery to remove it. Your doctors must also believe that, based on your surgery results, your cancer has a high chance of returning. This could be because the cancer had spread slightly beyond the main tumor in a specific way, or if not all the cancer cells were definitely removed at the edges during surgery.

Before you start, your body needs to have recovered well enough from surgery to receive the next stage of treatment. We also need to make sure your kidneys, blood, and liver are working well, as these are important for chemotherapy. We'll also ask for some information about your past medical history, including any alcohol use or smoking history.

For most types of head and neck cancer, your tumour will also need to be at a certain stage (stage III or IV). If your cancer is in the oropharynx (part of the throat) and is stage II, you might still be able to join if you have certain other factors like a particular gene marker (P16 positive) and a history of smoking.

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.

Are you between 18 and 74 years old?
Have you had surgery for squamous cell head and neck cancer?
Has your doctor told you your cancer is 'high-risk' for returning?
Are you well enough after surgery to start further treatment?
Are your kidneys, blood, and liver function within healthy limits?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be randomly assigned to one of two groups. Both groups will receive the standard post-surgery treatment, which involves three cycles of a chemotherapy drug called cisplatin given at the same time as radiotherapy. If you are in the treatment group, you will also receive doses of nivolumab alongside this standard treatment. You will have regular visits for medical checks, blood tests, and scans to see how you are responding to treatment and to monitor for any side effects. The total duration of your participation, including follow-up after the main treatment, will be explained by the study team, but typically involves close monitoring for several years to track if the cancer returns. All study-related medication and assessments will be provided at no cost to you.

Potential risks and benefits

Participating in this study might offer a potential benefit if the combination of nivolumab and standard treatment proves more effective at preventing your cancer from returning than standard treatment alone. However, there's also a chance that nivolumab could cause additional side effects, as with any new medication. The research team will carefully monitor you for any problems and help manage them. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Gustave Roussy
Verified postcode
Villejuif, France

Common questions

What is nivolumab?

Nivolumab is a drug that helps your body's immune system recognise and fight cancer cells more effectively. It's a type of immunotherapy.

What is 'standard of care' treatment?

Standard of care is the most common or accepted treatment that doctors currently use for a particular illness or condition, based on current medical knowledge.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, meaning both you and your doctors will know if you are receiving nivolumab in addition to the standard treatment.

What does 'high-risk' mean in this study?

It means that after your surgery, your doctors have identified certain features that suggest your head and neck cancer has a greater chance of coming back.

How long will I be followed in this study?

You will be followed for several years after your initial treatment to track your health and to see if the cancer returns. The exact timeframe will be explained by the study team.