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RAMPART

 

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RAMPART

Renal Adjuvant MultiPle Arm Randomised Trial - A Study of Immunotherapy as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy

 
 Phase 3, 1750 patients
 Last updated: September 15, 2018
 STATUS: Recruiting (accepting new patients) (per ClinicalTrials.gov/NCT03288532)

WHO

is the trial for?

Patients who have had surgery to remove their kidney cancer and who have a high or intermediate risk of their cancer coming back.

All patients must meet the following criteria:

  • Have histologically proven RCC (all cell types of RCC are eligible, except for pure oncocytoma, collecting duct, medullary and transitional cell cancer [TCC])
  • Have had surgery at least 28 days but no more than 91 days prior to participation
  • No evidence of disease after surgery
  • Have a tumour sample available and agree to provide to the study team
  • Have good overall health status (WHO Performance status 0 or 1)

WHAT

is the key question that this trial is attempting to answer?

In RAMPART we aim to find out whether taking one drug (durvalumab) or a combination of two drugs (durvalumab and tremelimumab) for one year can prevent or delay kidney cancer from coming back.

We will compare each of these treatment options with the current standard of care following kidney cancer surgery, which is active monitoring. This means no further treatment, but having regular checks so that if the cancer does come back further treatment options can be considered as early as possible.

WHY

patients might want to participate?

This clinical study offers patients an opportunity to access new therapies in the adjuvant setting. Similar therapies have improved outcomes for patients with advanced kidney cancer and patients with other cancers and so we hope that they will delay or prevent your kidney cancer from coming back.

We do not know whether you will gain any benefit personally from taking part in this study. However, the information we get will improve our knowledge of treatment for future patients with kidney cancer and potentially change the future standard of care for patients like you.

WHEN

will the trial be open?

The study opened to recruitment in July 2018.
Patients interested in this study should ask their physician if they might be eligible – 1750 patients are expected to participate worldwide. It will take approximately 5.5 years to reach this number.

WHERE

is the trial available?

At present the RAMPART study is only recruiting at a small number of hospitals in the UK. However, many hospitals are preparing to open the study and we expect to have 45 hospitals recruiting in the UK by early 2019. We also plan to open the study at hospitals in Australia, France and the US in 2019.

For a complete list of study locations, please click: Trial locations RAMPART.

STUDY

DESIGN

What does the study look like?

If tests show you are fit to take part and you agree to join the RAMPART study, you will be randomly assigned to one of 3 different groups.

  • Patients in group 1 will be closely monitored for one year.
  • Patients in group 2 will receive durvalumab every 4 weeks for up to one year.
  • Patients in group 3 will receive durvalumab in combination with tremelimumab for up to one year.
The RAMPART study is investigating two drugs, durvalumab and tremelimumab, which have been shown to be effective in treating a number of different types of cancer. Both drugs are given as intravenous (into the vein) infusions.
  • Durvalumab is a type of treatment called an immunotherapy, and may sometimes be referred to as an ‘anti-PDL1 drug’ or ‘immune checkpoint inhibitor’. It works by helping your own immune system to attack the cancer.
  • Tremelimumab is another immunotherapy treatment for cancer. It may sometimes be called an ‘anti-CTLA4 drug’ or ‘immune checkpoint inhibitor’. It also works by helping your immune system to attack the cancer.
 

1) All patients will be monitored on a regular basis (clinical and radiological observation).

2.) Durvalumab will be given intravenously (into the vein). Infusions are given every 4 weeks for up to one year (13 cycles maximum).

3.) The combination of durvalumab and tremelimumab will be administered as follows: Durvalumab is given intravenously every 4 weeks for up to one year. (13 cycles maximum) plus tremelimumab is given on day 1 and week 4 visits (i.e. 2 cycles).

 
 

HOW

do I get more information?

Patient organisations supporting kidney cancer patients in your country may offer additional information about this trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving kidney cancer patients. If there are no such organisations in your country, please email us for more information: Send e-mail to This email address is being protected from spambots. You need JavaScript enabled to view it.

CONNECT

with other patients on this trial

If you want to connect with other patients considering or participating in this trial, you can find them here: List of organisations worldwide.

SHARE

your experience 

If you would like to share your experience on this trial, send us an e-mail to: This email address is being protected from spambots. You need JavaScript enabled to view it.
Note that your experience would be helpful for other patients and patient organisations.

RESULTS

of the study

No results are available at this time. Future results will be linked here.
Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.
 
Back to clinical trials overview: How can I find a clinical trial for kidney cancer?