AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase II, Open-Label, Single-Arm, Multicentre Study of Carboplatin, Paclitaxel, and Tislelizumab in Biomarker-Selected Patients with Resectable Locally Advanced Oral Cavity Squamous Cell Carcinoma - PERSEPHONE Trial

This study, called PERSEPHONE, is for people with locally advanced oral cavity squamous cell carcinoma, which is a type of mouth cancer that hasn't spread far but is still serious. The main goal is to see how much a combination of chemotherapy drugs (carboplatin and paclitaxel) and a new cancer medicine called tislelizumab can shrink the tumour before surgery. This treatment is given before the operation, which is known as a 'neoadjuvant' approach. We'll be looking closely at the removed tumour tissue after surgery to see how well the drugs worked. We also want to understand the safety of this treatment and how it might impact patients' overall health and recovery in the long term.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondazione GONO Plus

Enrolment target

Start

15 Sep 2025

Resectable Locally Advanced Oral Cavity Squamous Cell Carcinoma

What is this study about?

This study is testing a new way to treat a specific type of mouth cancer called 'oral cavity squamous cell carcinoma.' This is a cancer that starts in the mouth. In this study, we are focusing on cancer that is 'locally advanced,' meaning it has grown in the local area but hasn't spread to distant parts of the body, and it can still be removed with surgery. The aim is to give some medicine before surgery, which doctors call 'neoadjuvant treatment.'

The medicines used in this study include two common chemotherapy drugs, carboplatin and paclitaxel, which work by killing cancer cells. We're also using a newer drug called tislelizumab. This type of drug helps your body's immune system fight the cancer. By giving these medicines before surgery, we hope to shrink the tumour, making the surgery potentially more effective and improving the chances of a good outcome.

The main thing we want to find out is how well this combination of medicines shrinks the tumour. After surgery, specialist doctors will examine the tumour tissue to see how many cancer cells are left. We'll also be carefully checking for any side effects of the treatments. In addition, we'll keep track of patients' health over time to see how long they remain free of cancer and their overall well-being. This study could help doctors understand if this combination treatment is a good option for people with this type of mouth cancer.

Key takeaways

This study tests new pre-surgery treatments for mouth cancer.
It combines chemotherapy with an immune-boosting drug called tislelizumab.
The main goal is to see how much the tumour shrinks before surgery.
Researchers will also track side effects and long-term health outcomes.
It's for adults with resectable, locally advanced oral cavity squamous cell carcinoma.
Participation involves infusions, surgery, and follow-up visits.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or older. Both men and women are welcome to take part. The most important thing is that you have a specific type of mouth cancer called 'locally advanced oral cavity squamous cell carcinoma' that your doctors believe can be removed with surgery.

There might be other health requirements too, as the doctors need to make sure the treatment is safe for you. This often means looking at your general health, and other medical conditions you might have. They will also need to review previous treatments you've had.

Your doctor will be able to tell you if your individual health situation and cancer type match the specific requirements of the study. It's really important to discuss all your medical history with them so they can make the best decision with you.

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 a type of mouth cancer called 'locally advanced oral cavity squamous cell carcinoma'?
Has your doctor said your cancer can be removed with surgery?
Are you generally well enough to receive chemotherapy and immunotherapy?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll first have some examinations and tests to make sure the treatment is right for you. Then, you'll receive a combination of three medicines: carboplatin, paclitaxel, and tislelizumab. These will be given as infusions (like a drip into your arm) over a set period before your surgery. You’ll have regular appointments to receive these treatments, and during these visits, the doctors and nurses will monitor you closely for any side effects and to see how you are responding to the medication.

After completing the pre-surgery treatment, you will have your planned operation to remove the tumour. Following your surgery, you will have follow-up visits where doctors will check on your recovery and health. They will also collect samples, like blood tests or tissue from your tumour, at different times to help understand how the treatment worked. The total length of your participation, including treatment and follow-up, will be explained fully by the study team, but it will involve multiple visits over time.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that the combination of medicines given before surgery might shrink your tumour more effectively, potentially improving your surgical outcome. You would also receive close monitoring from a dedicated medical team. However, there are potential risks, as these medicines can have side effects, which the study team will monitor closely. These can range from mild to more serious, and the team will discuss all known side effects with you before you decide to join. Remember, your participation is completely voluntary; you can choose to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Italy

Common questions

What is 'locally advanced oral cavity squamous cell carcinoma'?

This is a type of cancer that starts in the mouth (oral cavity) and has grown into nearby tissues, but it hasn't spread to distant parts of your body. It's still possible to remove it with surgery.

What does 'neoadjuvant setting' mean?

It means the treatment (in this case, chemotherapy and tislelizumab) is given before your main surgery. The aim is to shrink the tumour first.

What are carboplatin and paclitaxel?

These are common chemotherapy drugs that work by killing fast-growing cells, including cancer cells, to help shrink tumours.

What is tislelizumab?

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

Will I still have surgery if I join this study?

Yes, the plan is for you to have treatment before surgery, and then proceed with your planned operation to remove the tumour.