A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax®-TF-ADC) Monotherapy and in Combination with Other Agents in Subjects with Recurrent or Stage IVB Cervical Cancer
This clinical trial is designed for women with cervical cancer that has returned or reached an advanced stage (Stage IVB). The main goal is to test a new medicine called tisotumab vedotin, both on its own and in combination with other treatments like carboplatin, pembrolizumab, and bevacizumab. Researchers want to understand how safe these treatments are and what side effects they might cause. They are also looking at how effectively the treatments shrink tumours. This is an 'open-label' study, meaning everyone involved knows which treatment is being given. It's a combined Phase I and Phase II study, first checking for safe doses and then studying how well the treatment works in a larger group of people.
At a glance
What is this study about?
This study is for women who have cervical cancer that has either come back after treatment or has spread to other parts of the body (this is called Stage IVB cervical cancer). Researchers are investigating a new drug called tisotumab vedotin. This drug is designed to target cancer cells more directly, aiming to be effective while causing fewer side effects than traditional chemotherapy.
The study has two main parts. The first part, called 'dose escalation,' is about finding the safest dose of tisotumab vedotin, both by itself and when given with other common cancer treatments like carboplatin, pembrolizumab, and bevacizumab. Doctors will carefully watch for any side effects and how severe they are. The second part, 'dose expansion,' will then use these safe doses in more people to see how well the treatment works to shrink the cancer.
The main goal is to find out if tisotumab vedotin is safe and how effective it is at reducing the size of the cancer. They will also look at how long the treatment keeps the cancer from growing, how long people live, and how the body handles the new medicine. This research is important because it could lead to new treatment options for advanced cervical cancer.
Key takeaways
- This study is testing a new drug for advanced cervical cancer.
- It aims to find safe doses and see how well the new drug works.
- You might receive the new drug alone or with other common cancer medicines.
- Participation involves regular hospital visits for monitoring and treatment.
- This is an 'open-label' study, meaning everyone knows which treatment is given.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be at least 18 years old and a woman. You must have cervical cancer that has either returned after previous treatment or is at an advanced stage (Stage IVB).
Before you can take part, the study doctors will need to check your general health, including your blood tests and how well your organs are working. This is to make sure the treatment is as safe as possible for you and that you meet all the specific requirements of the study.
It's important to remember that even if you meet these general points, there might be other specific health conditions or previous treatments that could mean this study isn't right for you. The study team will discuss all of these with you in detail.
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 aged 18 or older?
- Do you have cervical cancer that has come back after treatment?
- Or do you have cervical cancer that has spread to other parts of your body (Stage IVB)?
- Are you able to attend regular hospital appointments?
- Are you willing for doctors to monitor your health very closely throughout the study?
What does participation involve?
If you decide to join this study, you'll have regular hospital visits. During these visits, doctors and nurses will monitor your health very closely. This will include physical exams, blood tests, and scans (like CT scans) to check how the treatment is affecting your cancer. You will receive the study medication, tisotumab vedotin, either by itself or with other widely used cancer drugs, through an infusion (into a vein).
The treatments and visits will continue for a period, and then there will be follow-up appointments to see how you are doing after the treatment has finished. The exact schedule and total duration of your participation will depend on which part of the study you are in and how you respond to the treatment. All medical care related to the study will be provided by the research team.
Potential risks and benefits
Locations (6)
- —UnverifiedCzechia
- —UnverifiedNetherlands
- —UnverifiedBelgium
- —UnverifiedIreland
- —UnverifiedSpain
- —UnverifiedItaly
Common questions
What is an 'open-label' study?
An 'open-label' study means that both you and your study doctor will know which treatment you are receiving. There's no placebo (dummy treatment) involved.
What is tisotumab vedotin?
Tisotumab vedotin is a new type of cancer medicine designed to target and kill cancer cells more specifically, often referred to as a 'targeted therapy' or 'antibody-drug conjugate'.
What are Phase I and Phase II studies?
Phase I studies are mainly about finding a safe dose and understanding side effects. Phase II studies then look at how well the treatment works in a larger number of people, while still watching for safety.
What is 'recurrent' or 'Stage IVB' cervical cancer?
Recurrent means the cancer has come back after previous treatment. Stage IVB means the cancer has spread to distant parts of the body.
Will I have to pay to be in the study?
No, all study-related treatments and tests will be paid for by the study sponsor. You will not have to pay to participate.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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