Active not recruitingPHASE2INTERVENTIONAL

A Phase II Clinical Trial of Cediranib and Olaparib Maintenance in Advanced Recurrent Cervical Cancer

This study, called COMICE, is testing a new way to treat advanced cervical cancer that has come back after initial treatment. It involves giving two drugs, Cediranib and Olaparib, to see if they can help keep the cancer under control for longer. We're looking for 108 women who have finished their first course of chemotherapy for advanced or recurrent cervical cancer and whose cancer has responded well or stabilised. Some participants will receive the active drugs, and others will receive a placebo (dummy drug), to compare how effective the new treatment is. The main goal is to see if these drugs can stop the cancer from growing for a longer period. Regular scans will be used to check on the cancer's progress.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

The Clatterbridge Cancer Centre NHS Foundation Trust

Enrolment target

Start

09 Oct 2018

Estimated completion

01 Mar 2026

Cervical Cancer

What is this study about?

Cervical cancer is a type of cancer that affects women and is a significant health concern, especially for those under 35. While early-stage cervical cancer can often be successfully treated with surgery or a combination of chemotherapy and radiotherapy, it can be more challenging to treat when it has spread or comes back after initial treatment. For these situations, there aren't many widely available treatment options that work well for a long time. Existing chemotherapy treatments often have limited effects, and the cancer can continue to grow.

This study is trying to find better ways to help women with advanced or recurrent cervical cancer. It focuses on women who have recently completed their first round of chemotherapy for this advanced stage of the disease and whose cancer has either shrunk, stayed the same, or showed a partial response to that treatment. The idea is to use two new drugs, Cediranib and Olaparib, as a follow-up, or "maintenance," treatment.

The hope is that these new drugs can work together to prevent or delay the cancer from growing further after the initial chemotherapy has done its job. By carefully studying how these drugs affect the cancer and how patients feel, researchers hope to find out if this combination can offer a new and more effective treatment option for women facing this challenging form of cervical cancer.

Key takeaways

This study evaluates new drugs (Cediranib, Olaparib) for advanced, recurrent cervical cancer.
It aims to see if the drugs can extend the time before the cancer grows again.
Participants have recently finished their first-line chemotherapy.
The study compares the active drugs to a placebo.
Regular scans (every 8 weeks) will monitor the cancer's progress.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you need to be over 18 years old and have a confirmed diagnosis of cervical cancer. Importantly, your cancer must be advanced or have returned after previous treatment, and you must have recently completed your first course of chemotherapy for this. Your cancer should have responded well to this first round of chemotherapy, meaning it has shrunk, stabilised, or partially responded.

You also need to be generally well enough to take part in a clinical trial. This includes having good kidney, liver, and blood test results, and being able to swallow medications. If you have other serious health conditions or your cancer is in a very specific location that could be treated with surgery, you might not be suitable for this study.

There are also specific requirements about previous treatments; for example, you shouldn't have received more than one type of chemotherapy specifically for your advanced or recurrent cancer. The study team will review all your medical information to see if this study is a good fit for 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 over 18 years old?
Do you have advanced or recurrent cervical cancer?
Have you recently completed your first course of chemotherapy for this advanced stage?
Did your cancer shrink or stabilise after your last chemotherapy?
Are your general health and organ functions (like kidneys and liver) good enough for a trial?
Are you able to swallow medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first undergo some tests, including CT or MRI scans, to check your current health and the status of your cancer. These scans must be done within 28 days before you join the study. Once enrolled, you will be assigned by chance (like flipping a coin) to receive either the active drugs (Cediranib and Olaparib) or a dummy pill (placebo) along with Cediranib. Neither you nor your doctor will know which treatment you are receiving.

You will take these medications daily, and you will continue treatment for as long as your cancer doesn't get worse, as long as the side effects are manageable, or until you decide to stop. Every eight weeks, you will have follow-up CT or MRI scans to monitor your cancer's progress. You will also have regular blood tests and check-ups with the study team to monitor your health and any possible side effects. The total duration of your participation will depend on how you respond to the treatment.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. The potential benefit of this study is that the combination of Cediranib and Olaparib might help to control your cervical cancer for a longer period compared to standard care or placebo. However, there's no guarantee this treatment will work for you, and it's possible you will experience side effects from the study drugs. These side effects can vary from person to person. You will be closely monitored by the study team, and they will discuss any potential side effects with you. Remember, participating in this study is completely voluntary, and you can withdraw at any time 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.

Clatterbridge Cancer Centre
Verified postcode
Metropolitan Borough of Wirral, United Kingdom

Common questions

What is the main purpose of this study?

The main purpose is to see if two new drugs, Cediranib and Olaparib, can stop advanced cervical cancer from growing for longer after initial chemotherapy.

Who can join this study?

Women over 18 with advanced or recurrent cervical cancer who have completed their first chemotherapy and whose cancer responded well to it.

Will I know if I'm getting the real drugs or a dummy pill?

No, neither you nor your doctor will know if you are receiving the active drugs or a placebo. This is to ensure fair comparison.

How often will I have check-ups?

You will have scans every 8 weeks to check the cancer, along with regular blood tests and doctor visits.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point without it affecting your future medical care.