A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic, or Persistent Cervical Carcinoma
This research is a Phase 2 clinical trial exploring a new treatment option, LN-145, for women battling cervical cancer that has returned, spread to other parts of the body, or continued to grow despite previous treatments. LN-145 is a type of immunotherapy, which uses the body's own immune system to fight cancer. The study aims to understand two main things: how effective LN-145 is at shrinking tumours (this is called the 'response rate') and whether the treatment is safe for patients. Researchers will also be looking at other important factors like how long the treatment's effects last and overall survival. Different groups of patients within the study will help scientists gather this crucial information.
At a glance
What is this study about?
This study is a clinical trial, which means it's a carefully planned medical research study involving people. Its main goal is to test a new way of treating cervical cancer. The specific treatment being looked at is called LN-145, and it falls into a category of treatments known as immunotherapy. Immunotherapy works by boosting your body's natural defences – your immune system – to recognise and fight cancer cells.
The trial is focusing on women who have cervical cancer that has either come back after treatment, spread to other parts of their body (metastatic), or continued to grow even with other therapies (persistent). As a Phase 2 study, the main purpose is to see if this new treatment can make tumours shrink and, importantly, to identify any side effects that might occur. This helps researchers understand if LN-145 is a promising treatment that should be studied further in larger trials.
To do this, different groups of patients will be involved. The researchers will be looking very closely at how the tumours respond to the treatment, if the treatment keeps the cancer from growing for a period, and how safe the treatment is overall for patients. This involves carefully monitoring any changes in the cancer and observing any new health problems that might arise during the study.
Key takeaways
- This study is testing a new immunotherapy (LN-145) for certain types of advanced cervical cancer.
- It aims to see how well LN-145 shrinks cancer and if it's safe.
- The study involves women whose cervical cancer has returned, spread, or not responded to prior treatments.
- You will receive LN-145 alongside other specific medications.
- Regular health checks and scans will be part of the study participation.
Who may be eligible?
This study is looking for women who are at least 18 years old.
You would be considered for this study if you have cervical cancer that has either returned after previous treatment, spread to other parts of your body, or has not gone away despite the treatments you've had so far.
There will be other specific medical checks to make sure this study is safe and appropriate for you, so your doctor would need to review all your health information.
- Are you 18 years old or older?
- Have you been diagnosed with cervical cancer?
- Has your cervical cancer come back, spread, or continued to grow despite other treatments?
- Are you female?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will receive a new treatment called LN-145, along with some other medications designed to help it work. These other medications include fludarabine phosphate, cyclophosphamide, and aldesleukin. Before starting, and throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to see how the treatment is affecting your cancer and your overall health.
These visits will allow doctors to monitor how well the treatment is working and to keep a close eye on any side effects you might experience. The number and frequency of visits will be explained to you in detail, as will the total length of time you'll be involved in the study. You will also have follow-up appointments after you finish the main treatment period to ensure your health continues to be monitored.
Potential risks and benefits
Locations (5)
- —Germany
- —Netherlands
- —France
- —Italy
- —Spain
Common questions
What is immunotherapy?
Immunotherapy is a type of treatment that helps your body's own immune system fight cancer.
What does 'recurrent' or 'metastatic' cervical cancer mean?
Recurrent means the cancer has come back. Metastatic means it has spread to other parts of the body.
What is a Phase 2 study?
A Phase 2 study is designed to see if a new treatment works and to identify its safety and side effects.
Will I receive other treatments alongside LN-145?
Yes, you will receive other medications like fludarabine phosphate, cyclophosphamide, and aldesleukin as part of the study treatment.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time without it affecting your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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