Not yet recruitingPHASE2INTERVENTIONAL

Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers

This study is for people with a type of head and neck cancer called squamous cell carcinoma that has returned in the same area after previous treatments like surgery, radiotherapy, and chemotherapy, and hasn't fully responded to Nivolumab immunotherapy. Researchers are testing a new approach where they inject a combination of chemotherapy drugs (Gemcitabine, Paclitaxel, and Carboplatin) directly into the tumor. The goal is to see if this injected chemotherapy, along with ongoing Nivolumab treatment, can be more effective at shrinking the tumor and improving outcomes. This is a Phase 2 study, meaning it's exploring how well this new treatment works and if it's safe for patients.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Centre Hospitalier Universitaire, Amiens

Enrolment target

Start

01 Nov 2025

Estimated completion

01 Apr 2027

Squamous Cell Carcinoma of the Head and Neck Paclitaxel Carboplatin Nivolumab

What is this study about?

This study is exploring a new way to treat a type of head and neck cancer called squamous cell carcinoma of the head and neck (SCCHN). This is for people whose cancer has come back locally, meaning in the same area, after already having various treatments like surgery, radiation, and chemotherapy. It's also for those who have started immunotherapy with a drug called Nivolumab, but their cancer hasn't fully responded to it.

Currently, when this type of cancer returns and hasn't responded well to standard treatments, options can be limited. Doctors have previously tried injecting chemotherapy directly into the tumor, but some older methods caused problems like damage to healthy tissue. This study is trying a newer combination of chemotherapy drugs (Gemcitabine, Paclitaxel, and Carboplatin) injected directly into the tumor. The hope is that these drugs will be better tolerated and cause less damage to surrounding healthy tissue.

The idea behind this study is that by injecting chemotherapy directly into the tumor, it can tackle the cancer cells more intensely in that specific area. When this is combined with Nivolumab, which helps your body's immune system fight cancer, doctors hope to get an even stronger response. The chemotherapy might also help the immune treatment work better by making the cancer cells more visible to your immune system. This combination could potentially offer a new and more effective treatment option for this challenging type of cancer.

Key takeaways

This study explores a new treatment for head and neck cancer that has recurred and not fully responded to existing immunotherapy.
It combines direct tumor injections of chemotherapy drugs with ongoing Nivolumab immunotherapy.
The aim is to improve treatment effectiveness and potentially overcome resistance to previous therapies.
Participation involves receiving injections into the tumor in addition to your existing immunotherapy.
This is a Phase 2 study, focused on how well the treatment works and its safety.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old and have a good general health status, meaning you are able to carry out most daily activities without significant difficulty. Your head and neck cancer must be a specific type called squamous cell carcinoma, and it must have returned in the same area after you've already had treatments like surgery, radiotherapy, or chemotherapy (including platinum-based drugs and cetuximab). You also need to be currently receiving Nivolumab immunotherapy, but it hasn't been effective enough in controlling your cancer. The tumor must be in a location that doctors can examine and see clearly, for example, on a scan.

Even if the cancer has spread to other parts of your body (called metastases), you might still be able to join if those metastases aren't immediately life-threatening and if treating the local head and neck recurrence is expected to help you. You'll also need to have certain blood test results within specific healthy ranges, including your white blood cells (neutrophils), platelets, and markers for kidney and liver function. You must have social insurance to cover healthcare costs and be willing to give your informed consent, which means you fully understand the study and agree to participate.

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 18 years old or older?
Do you have squamous cell carcinoma of the head and neck that has returned locally?
Have you already received past treatments (surgery, radiation, chemo including platinum drugs/cetuximab)?
Are you currently receiving Nivolumab for your cancer, but it hasn't been effective enough?
Is your general health good enough for you to do most daily activities?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue to receive your Nivolumab treatment. In addition, a new procedure will be introduced where a very thin tube (catheter) is carefully inserted into your tumor. Through this tube, a combination of chemotherapy drugs (Gemcitabine, Paclitaxel, and Carboplatin) will be directly injected into the tumor site. The number of injections and how often they happen would be clearly explained to you by the study team. You would need to attend regular appointments for these injections and for monitoring your health and how the treatment is working. This will involve physical examinations, blood tests, and scans to track the size of the tumor. The total duration of your participation, including follow-up after the main treatment, would be discussed with you, but typically, studies like this involve assessments over several months.

Potential risks and benefits

Participating in this study might offer a potential benefit of an improved response to your cancer treatment, especially since current options for locally recurrent head and neck cancer can be limited. Combining chemotherapy injected directly into the tumor with immunotherapy could potentially lead to better tumor shrinkage or control. However, like any medical treatment, there are potential risks. You might experience side effects from the chemotherapy, even though it's given directly into the tumor, or from the procedure itself, such as bruising, pain, or infection at the injection site. Your medical team will monitor you closely for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

CHU Amiens Picardie
Verified postcode
Amiens, France

Common questions

What kind of cancer is this study for?

This study is for a type of head and neck cancer called squamous cell carcinoma that has come back in the same area after previous treatments.

What is 'intratumoral' treatment?

'Intratumoral' means the medicines are injected directly into the tumor itself, rather than into your veins or taken as a pill.

Will I stop my current Nivolumab treatment if I join this study?

No, you will continue to receive your Nivolumab treatment alongside the new injected chemotherapy in this study.

What phase is this study, and what does it mean?

This is a Phase 2 study. This means the main goal is to find out how well the new treatment works and to continue checking its safety in a larger group of people.

What if I experience side effects during the study?

The study team will monitor you closely for any side effects, and they will provide care and guidance to manage them.

How to find out more

Aline HOUESSINON, MD

houessinon.aline@chu-amiens.fr 03 22 45 54 99 Official trial record

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