C5721002 _ A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator’s Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer
This study, called C5721002, is a Phase 3 clinical trial for women with cervical cancer that has either returned (recurred) or spread to other parts of the body (metastatic), and has already been treated with one or two types of chemotherapy. The main goal is to see if a new drug, Tisotumab Vedotin, helps patients live longer compared to standard chemotherapy chosen by the doctor. Researchers will also look at how long people live without their cancer growing, how many see their cancer shrink, and how the new drug affects their quality of life. This trial aims to find better treatment options for this type of advanced cervical cancer.
At a glance
What is this study about?
This study is looking into a new treatment for cervical cancer, specifically for women whose cancer has returned after initial treatment or has spread to other parts of their body. For these patients, doctors have already tried one or two types of chemotherapy, but unfortunately, the cancer hasn't gone away or has come back.
The new treatment being tested is called Tisotumab Vedotin. This study wants to find out if Tisotumab Vedotin is more effective than the standard chemotherapy options currently used. Doctors will compare how long patients live when taking the new drug versus those receiving standard chemotherapy. They'll also check how well the drugs reduce the size of the cancer and how they affect a person's overall quality of life.
The main aim of this research is to discover a better way to treat advanced cervical cancer when other treatments haven't worked as well as hoped. Finding more effective treatments is very important for improving the lives of women facing this challenging type of cancer.
Key takeaways
- This study evaluates a new drug, Tisotumab Vedotin, for advanced cervical cancer.
- It's for women whose cancer has returned or spread after previous chemotherapy.
- The main goal is to see if the new drug helps patients live longer.
- Participants will be randomly assigned to either the new drug or standard chemotherapy.
- Close monitoring for treatment effects and side effects will be provided.
- Your quality of life will also be assessed throughout the study.
Who may be eligible?
To be considered for this study, you must be a woman aged 18 years or older. Your cervical cancer must have either come back after previous treatment or spread to other parts of your body.
Also, you need to have already received one or two different types of chemotherapy for your cervical cancer, and it's understood that these treatments haven't continued to work effectively or the cancer has returned.
There will be other health checks and tests to make sure that the study treatment is safe for you and that you meet all the research requirements. These will be discussed in detail by your doctor if you express an interest in taking part.
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 a woman?
- Are you 18 years old or older?
- Has your cervical cancer come back or spread?
- Have you already had one or two chemotherapy treatments for your cervical cancer?
- Are you willing to be randomly assigned to a treatment group?
What does participation involve?
If you decide to join this study, you will be randomly assigned to receive either the new drug (Tisotumab Vedotin) or one of several standard chemotherapy drugs chosen by your doctor. This means you won't get to choose which treatment you receive. You will have regular visits to the hospital or clinic for your treatment and to have various tests performed. These tests will include blood samples, scans to monitor your cancer, and questionnaires about your health and how you are feeling. The frequency of visits might change over time, and you'll be told exactly what to expect. Throughout the study, you'll be closely monitored for any side effects. The total duration of your participation will depend on how your cancer responds to treatment and your overall health, but you would continue treatment and follow-up for as long as it's safe and beneficial.
Potential risks and benefits
Locations (13)
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Common questions
What is the new drug being tested?
The new drug is called Tisotumab Vedotin. It's being compared to standard chemotherapy treatments.
What kind of cervical cancer is this study for?
This study is for cervical cancer that has come back (recurred) or spread (metastatic) after already being treated with chemotherapy.
What is a 'Phase 3' study?
A Phase 3 study means the treatment has already shown some promise in earlier stages, and now researchers want to confirm if it's better than existing treatments on a larger number of patients.
Will I get to choose my treatment?
No, if you join, you will be randomly chosen to receive either the new drug or one of the standard chemotherapy treatments.
How long will I be in the study?
Your time in the study will depend on how your cancer responds and your health, with regular monitoring and follow-up provided.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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