RecruitingPHASE2INTERVENTIONAL

A Feasibility Window Study of Pembrolizumab Prior to Second Evacuation for Post-molar Gestational Trophoblastic Neoplasia

This study, called RESOLVE, is for women with a rare condition called Gestational Trophoblastic Neoplasia (GTN) that can happen after pregnancy. While most GTN is cured by initial surgery, some women need further treatment. Standard options like chemotherapy can have tough side effects. This study investigates Pembrolizumab, a type of immunotherapy that helps your body’s immune system fight cancer cells, as a gentler alternative to chemotherapy before a second surgery. Doctors want to see if this approach is practical and safe for 20 patients. If successful, it could lead to larger studies to help women with recurrent GTN avoid harsh treatments.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Imperial College London

Enrolment target

Start

14 Feb 2024

Estimated completion

01 Aug 2026

Gestational Trophoblastic Disease Gestational Trophoblastic Neoplasia Gestational Trophoblastic Tumor, Recurrent

What is this study about?

Imagine you've had a pregnancy, and afterwards, some cells from the placenta don't act quite right. This is called Gestational Trophoblastic Disease (GTD). Most of the time, these cells are just pre-cancerous and a simple surgery can remove them. However, for a small number of women, these cells can become more serious, growing into something called Gestational Trophoblastic Neoplasia (GTN).

If you have GTN, the first step is usually to remove the affected tissue with surgery. For about 15% of women, this first surgery isn't enough, and the GTN comes back or doesn't go away completely. When this happens, doctors usually suggest more surgery or chemotherapy. Chemotherapy can be very effective, but it often comes with unpleasant side effects, both short-term like feeling sick or tired, and long-term effects that can impact your health and quality of life.

This is where this trial comes in. Doctors are looking for ways to treat GTN that are gentler than chemotherapy. They are investigating a new type of treatment called immunotherapy. Immunotherapy works by boosting your body's own natural defence system, your immune system, to find and fight the unhealthy cells. The drug being tested in this study is called Pembrolizumab. It helps your immune system recognise and attack the GTN cells, which normally try to hide. Pembrolizumab has been shown to be quite safe in other settings, making it a promising option to explore for GTN. This RESOLVE study is a small, initial step to see if giving Pembrolizumab before a second surgery for GTN is a practical and good idea, potentially paving the way for larger studies in the future.

Key takeaways

This study explores a new, gentler treatment for GTN after pregnancy.
It uses immunotherapy (Pembrolizumab) to help your immune system fight the disease.
Researchers want to see if it's a safe and practical alternative to chemotherapy.
Participation involves either surgery alone or a dose of Pembrolizumab before surgery.
All participants will be followed up for a year after their treatment.
The study is a small, initial step to assess feasibility for a larger trial.

Who may be eligible?

This study is looking for women aged 18 or older who have developed GTN after a pregnancy and whose condition has returned or not completely gone away after their first surgery.

To be included, your GTN must be considered 'low risk' by specific medical guidelines, and you shouldn't have any spread of the disease to other parts of your body. Your body's important functions, like blood counts and kidney/liver health, need to be working well. Also, the GTN must be within your womb and not too close to the outer wall.

You wouldn't be able to join if you have certain other types of cancer, if you have a different specific type of GTN (like choriocarcinoma), or if you've had other treatments in the past that would stop you from safely receiving this study treatment. All participants also need to agree to use effective birth control or avoid pregnancy for one year after the second surgery.

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 18 years old or over?
Have you been diagnosed with GTN that came back or didn't go away after your first surgery?
Has your doctor told you your GTN is 'low risk'?
Do you have no signs of GTN spread to other parts of your body?
Are you able to use effective birth control or avoid pregnancy for one year after your surgery?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be put into one of two groups by chance. One group (10 women) will have the second surgery as planned. The other group (10 women) will receive a single dose of the study drug, Pembrolizumab, before their second surgery. All participants will be recruited from Charing Cross Hospital.

After your surgery, doctors will continue to follow your health and progress for one year. This will involve regular check-ups and monitoring to see how you are doing and how well the treatment worked for you.

Potential risks and benefits

Taking part in this study could offer the benefit of receiving a potentially gentler treatment option for your GTN, which might help avoid the more severe side effects of chemotherapy. However, like all medications and medical procedures, Pembrolizumab and surgery carry potential risks, and there could be side effects. Because this is a pilot study, researchers are still learning about how well this new approach works. You will be closely monitored for any reactions or problems. Remember, your participation is completely voluntary, and you have the right to withdraw from the study 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.

Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Gestational Trophoblastic Neoplasia (GTN)?

GTN is a rare condition that can happen after pregnancy where cells from the placenta don't develop normally and can grow in a harmful way.

What is Pembrolizumab?

Pembrolizumab is a type of immunotherapy. It helps your body's immune system recognise and fight against cancer cells.

Why are doctors doing this study?

Doctors want to find out if using Pembrolizumab before a second surgery for GTN is a safe and effective option that might be gentler than traditional chemotherapy.

How many people will be in this study?

A total of 20 patients will take part in this small study, split into two groups of 10.

How long will I be followed after treatment?

If you participate, your health will be monitored for one year after your surgery.

How to find out more

Aaron Clarke

aeclarke@ic.ac.uk 02033117740 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.