AuthorisedTherapeutic exploratory (Phase II)Interventional

Phase II study of Cemiplimab before and after standard chemoradiotherapy for patients with locally advanced cervical carcinoma. CADILLACC TRIAL

The CADILLACC trial is a study looking at a new approach for women with locally advanced cervical cancer. This type of cancer has started to spread to nearby tissues but hasn't reached distant parts of the body. The study aims to see if adding an investigational drug called Libtayo (cemiplimab) before and after standard treatment (which includes chemotherapy like Cisplatino Sandoz and radiotherapy) can improve how well the treatment works. Researchers will be carefully checking to see if this combined treatment shrinks the tumour or makes it disappear. This is a Phase II study, meaning it's still in the earlier stages of human testing, focusing on whether the treatment is effective and safe.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondazione IRCCS Istituto Nazionale Dei Tumori

Enrolment target

Start

06 Feb 2026

locally advanced cervical carcinoma

What is this study about?

This study, called CADILLACC, is designed for women who have locally advanced cervical cancer. This means the cancer has grown beyond the cervix but hasn't spread to other distant organs. Standard treatment for this type of cancer usually involves a combination of chemotherapy (using a drug like Cisplatino Sandoz) and radiotherapy (using high-energy rays to kill cancer cells).

In this trial, doctors are exploring a new approach. They are adding an investigational drug called Libtayo (cemiplimab) to the standard treatment. Patients in the study will receive Libtayo both before they start their chemotherapy and radiotherapy, and again after those treatments are finished. The main goal is to see how many patients experience a significant reduction in the size of their tumour or if it disappears completely.

By adding Libtayo, researchers hope to improve the success rate of treating locally advanced cervical cancer. They will be closely monitoring how patients respond to this new combination, how long patients live without the cancer growing, and their overall survival. This is a Phase II study, which means it's an important step in determining if this new treatment strategy could be a valuable option for future patients.

Key takeaways

This study is for women with locally advanced cervical cancer.
It tests adding a new drug (Libtayo) to standard chemotherapy and radiotherapy.
The main goal is to see if this combination shrinks the cancer more effectively.
It's a Phase II study, focusing on effectiveness and safety.
Participation involves receiving treatments and regular health checks.
You can withdraw from the study at any time.

Who may be eligible?

This study is specifically designed for adult women aged 18 and older. If you have been diagnosed with locally advanced cervical cancer, you might be able to take part.

There will be specific medical criteria that doctors will need to check to make sure the study is a safe and appropriate option for you. This often includes reviewing your general health, other medical conditions you might have, and previous treatments.

Only your doctor can confirm if you meet all the requirements to join this particular research study.

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 an adult woman, aged 18 or older?
Have you been diagnosed with locally advanced cervical cancer?
Are you able to undertake standard chemotherapy and radiotherapy?
Are you willing to have an investigational drug as part of your treatment?
Are you able to attend regular hospital visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the investigational drug Libtayo both before your standard chemotherapy and radiotherapy, and then continue to receive it after those treatments. You would also receive Cisplatino Sandoz chemotherapy and radiotherapy as part of the standard care. Your participation would involve regular hospital visits for these treatments and for appointments where doctors and nurses would carefully monitor your health and how your cancer is responding. This would include physical examinations, blood tests, and scans (like MRI or CT scans) to check the size and spread of the tumour. The full duration of your participation, including follow-up appointments, would be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new, investigational treatments that aren't yet widely available, and close medical monitoring. However, there are also potential risks, as new treatments can have side effects that are not yet fully understood. You might experience side effects from the investigational drug or the combination of treatments. It's important to discuss all potential risks and benefits with your doctor. Remember, participating in a clinical trial is always voluntary, and you have the right to withdraw at any time, for any reason, without affecting your future medical care.

Locations (1)

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

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Unverified
Italy

Common questions

What is 'locally advanced cervical carcinoma'?

It means the cervical cancer has grown into nearby tissues but hasn't spread to distant parts of the body.

What are Libtayo and Cisplatino Sandoz?

Cisplatino Sandoz is a standard chemotherapy drug. Libtayo is an investigational drug being tested to see if it can improve cancer treatment.

What does 'Phase II study' mean?

This means it's an earlier stage study focusing on whether the new treatment idea is effective and safe for patients.

Will I definitely get the new drug?

Yes, in this particular study, all participants would receive Libtayo in combination with standard treatment.

How long would I be in the study?

The exact duration would be explained by the study team, and includes treatment periods and follow-up checks.