30th June 2023
RAMPART IS NOW CLOSED TO RECRUITMENT
At 5pm (BST) on Friday 30th June 2023, RAMPART, in its current form, closed to recruitment. We will not be randomising any more patients to the trial from now.
Nothing will change for current participants. All patients currently enrolled on the trial will continue their treatment and follow-up as per protocol.
A protocol amendment reflecting the changes to the trial is currently with the regulators, awaiting their review.
We wish to thank all out sites for their hard work recruiting patients to RAMPART and for your continued participation and support.
3rd May 2023
RAMPART CLOSURE TO RECRUITMENT
Following discussions between the TMG and our pharmaceutical partners, AstraZeneca, we are writing to notify you that RAMPART will be closing to recruitment on Friday 30th June 2023.
Patients already participating in RAMPART and those who are randomised between now and the end of June will continue their allocated treatment/Follow-up as per the protocol.
There are two documents linked below that provide details about this decision and what this means for your sites moving forward. These documents are:
The RAMPART Trial Management team wish to thank you all for your continued work and support on RAMPART and we look forward to continuing to work with you in the coming years.
29th March 2023
RAMPART SUBSTANTIAL AMENDMENT 22 (Protocol v6.0)
We have now received approval from the MHRA, HRA and REC for an amendment to the RAMPART Protocol (v6.0, Aug-22).
Changes to the protocol
There are two main reasons for amending the trial Protocol. Firstly, we are introducing a new patient population into the RAMPART trial. Patients that develop a single fully resected soft tissue metastasis at any organ site between 6-24 months after nephrectomy will now be considered eligible. These patients are considered to have a similar risk to those in the high risk group in RAMPART, and are currently treated in the same manner as adjuvant patients. They are an understudied group of patients with a substantial risk of relapse that the RAMPART Trial Management Group believe would benefit from adjuvant therapy after their metastectomy. This change will more closely align the RAMPART patient population with that of the KEYNOTE-564 and IMMOTION-010 studies.
As part of this amendment, we have also made changes to the list of mandatory blood tests that must be performed and checked as part of screening and prior to each treatment administration (see tables 3, 4, 13 and 14 in the RAMPART Protocol). After review by the clinical members of the Trial Management Group, we have removed the blood tests that were both considered to have lower clinical importance in this setting, and which have very low numbers of associated adverse events reported within the trial to date. All participants will still be required to have the reduced list of blood tests checked prior to randomisation and treatment to ensure that it is safe to proceed, and sites are advised to continue to undertake any additional investigations as clinically indicated.
We have taken this opportunity to make a number of smaller additional changes to the RAMPART Protocol. All amendments are listed in full in the supporting document Summary of Changes from RAMPART Protocol v5.0 to v6.0.
Updated supporting documents
Alongside the updated Protocol, we are also introducing some new and updated supporting documents. The Durvalumab Investigator Brochure (IB) has recently been updated by AstraZeneca and there are new expected toxicities listed for both durvalumab monotherapy and the combination with tremelimumab. It is our intention to use this new version of the IB (v17.0, Oct-2021) as our Reference Safety Information (RSI) moving forward.
In response to the updated safety information, we have made some changes to our Participant Information Sheet (PIS) to ensure that our patients are adequately informed. The PIS has also been updated to reflect changes to the standard of care in the UK. These updates to the PIS have been approved by the TMG, CI (Dr James Larkin) and Patient and Public Involvement (PPI) representative. The new version of the PIS (v7.0, 17-Oct-2022) should be given to all prospective patients once local approval has been granted. It is not necessary to re-consent existing participants as the TMG do not feel these updates change the risk/benefit assessment.
Please note that we have also made some changes to existing CRFs to accommodate the protocol amendments. New versions of the Randomisation CRF (Form01), Eligibility CRF (Form02), Surgery CRF (Form03), Treatment CRF (Form05A) and Additional Lab (Form19A). These forms were not part of the substantial amendment submissions and do not require approval for use
We have prepared a brief set of slides to provide some additional details and guidance about the changes to the RAMPART Protocol and trial practice. These slides should be forwarded to all members of the local research team who are working on the study. Please ensure that the RAMPART Training Log is updated following review of the slides and a copy sent to the RAMPART team (email@example.com).