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RecruitingPHASE3INTERVENTIONAL

Renal Adjuvant MultiPle Arm Randomised Trial

This research study, called RAMPART, is investigating new ways to treat kidney cancer (renal cell carcinoma) after surgery. Currently, after an operation to remove the cancer, doctors usually just monitor patients. However, for many, the cancer can still return. This study is testing if two drugs, durvalumab and tremelimumab (used alone or together), can prevent the cancer from coming back or help people live longer, compared to the usual monitoring approach. It's for people who have had their kidney cancer surgically removed and face a moderate to high risk of it returning. The study is particularly interested in whether these new treatments improve the time people live without their cancer returning, or their overall lifespan.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
University College, London
Enrolment target
1,750
Start
19 Jul 2018
Estimated completion
01 Dec 2034

What is this study about?

Imagine you've had surgery for kidney cancer, and the tumour has been removed. That's a huge step. Currently, after this operation, the usual approach is to keep a close eye on you through regular check-ups and scans, which doctors call active monitoring. However, for some people, even after successful surgery, there's a chance the cancer might come back. This is especially true for those with a higher risk.

This study, called RAMPART, aims to see if we can do better than just monitoring alone. It's looking into two specific drugs, durvalumab and tremelimumab, which are types of immunotherapy. These drugs work by helping your body's own immune system fight cancer cells. Researchers want to find out if giving one of these drugs alone, or both together, after surgery can be more effective than just monitoring. The hope is that these treatments could prevent the cancer from returning, or help people live longer and healthier lives.

This is a 'Phase III' trial, which means these drugs have already been tested in earlier stages and shown promise. Now, they're being compared against the current standard monitoring approach in a larger group of people to confirm if they truly offer a benefit. It's a randomised study, meaning participants will be assigned to either receive one of the drugs, both drugs, or continue with standard monitoring, by chance. This helps make sure the results are fair and reliable.

Key takeaways

  • Tests new drugs (immunotherapies) after kidney cancer surgery.
  • Aims to prevent cancer from returning or improve lifespan.
  • Compares drugs to standard monitoring.
  • For people at moderate to high risk of cancer recurrence.
  • You will be assigned to a treatment group or monitoring by chance.
  • Regular check-ups and blood tests are part of participation.

Who may be eligible?

This study is looking for people who have had kidney cancer (renal cell carcinoma) that has been surgically removed. They are specifically interested in patients where there's no visible cancer left after the operation, and who have a moderate to high chance of the cancer coming back.

You would need to have had your surgery between 28 and 91 days before joining the study, and recent scans should show no remaining cancer. Your overall health should be generally good, meaning you can manage your daily activities without too much difficulty. Also, your blood test results, like your blood count and liver function, need to be within a healthy range.

Some types of kidney cancer are not included, and if you have certain other serious health conditions, you might not be able to take part. The research team will carefully check all details from your medical history and recent tests to confirm if you are suitable for the study.

Quick self-check
  • Have you had kidney cancer surgery?
  • Was your surgery between 4 and 13 weeks ago?
  • Do scans show no cancer remaining after surgery?
  • Is your general health good and do you move around fine?
  • Do you have a healthy blood count and normal organ function?
  • Are you 18 years old or older?

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 first undergo a series of assessments, including physical exams, blood tests, and scans, to ensure you meet all the requirements. You will then be randomly assigned to one of three groups: receive durvalumab alone, receive durvalumab and tremelimumab together, or continue with the usual monitoring approach.

If you are in one of the treatment groups, the drugs will be given through a drip (intravenously) at specific intervals. The exact schedule for these infusions will be explained to you in detail by the study team. You will have regular follow-up appointments, which will include physical examinations, blood tests, and scans, to monitor your health and check for any signs of the cancer returning or any side effects from the treatment. These visits will be scheduled over a period of time, similar to what you would experience with standard monitoring. The total duration of active treatment and follow-up will depend on the specific treatment plan and is part of a multi-year study.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing new treatments before they are widely available, which in this case might reduce the chance of your kidney cancer returning. However, there are potential risks, as the drugs being tested can have side effects, which the study team will discuss with you in detail. There's also no guarantee that the new treatments will be more effective than standard monitoring. It's important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (35)

  • Aberdeen Royal Infirmary
    Aberdeen, United Kingdom· Recruiting
  • Ysbyty Gwynedd
    Bangor, United Kingdom· Recruiting
  • Royal Bournemouth Hospital
    Bournemouth, United Kingdom· Recruiting
  • Bristol Haematology and Oncology Centre
    Bristol, United Kingdom· Recruiting
  • Addenbrookes Hospital
    Cambridge, United Kingdom· Recruiting
  • Velindre Cancer Centre
    Cardiff, United Kingdom· Recruiting
  • Broomfield Hospital
    Chelmsford, United Kingdom· Recruiting
  • Cheltenham General Hospital
    Cheltenham, United Kingdom· Recruiting
  • Colchester General Hospital
    Colchester, United Kingdom· Recruiting
  • University Hospital Coventry & Warwickshire
    Coventry, United Kingdom· Recruiting
  • Western General Hospital
    Edinburgh, United Kingdom· Recruiting
  • Beatson West of Scotland Cancer Centre
    Glasgow, United Kingdom· Recruiting

+23 more sites — see the official record for the full list.

Common questions

What is 'renal cell carcinoma'?

It's the most common type of kidney cancer.

What does 'adjuvant' mean in this study?

It means the treatment is given after surgery to try and stop the cancer from coming back.

Are the drugs in this study new?

Yes, durvalumab and tremelimumab are newer medicines called immunotherapies.

What does 'active monitoring' mean?

It means your doctors will regularly check your health and for any signs of the cancer returning, usually with scans and appointments.

Will I know if I'm getting the new treatment or just monitoring?

No, because this is a 'randomised' study, you won't know which group you are in to ensure fair results. This is decided by chance.

How to find out more

RAMPART Trial Management Team

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

Interested in taking part?

Register your interest

Share your details and the research team for "Renal Adjuvant MultiPle Arm Randomised Trial…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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