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dc.contributor.authorOza, Bhavna
dc.contributor.authorFrangou, Eleni
dc.contributor.authorSmith, Ben
dc.contributor.authorBryant, Hanna
dc.contributor.authorKaplan, Rick
dc.contributor.authorChoodari-Oskooei, Babak
dc.contributor.authorPowles, Tom
dc.contributor.authorStewart, Grant D.
dc.contributor.authorAlbiges, Laurence
dc.contributor.authorBex, Axel
dc.contributor.authorChoueiri, Toni K.
dc.contributor.authorDavis, Ian D.
dc.contributor.authorEisen, Tim
dc.contributor.authorFielding, Alison
dc.contributor.authorHarrison, David
dc.contributor.authorMcWhirter, Anita
dc.contributor.authorMulhere, Salena
dc.contributor.authorNathan, Paul
dc.contributor.authorRini, Brian
dc.contributor.authorRitchie, Alastair
dc.contributor.authorScovell, Sarah
dc.contributor.authorShakeshaft, Clare
dc.contributor.authorStockler, Martin R.
dc.contributor.authorThorogood, Nat
dc.contributor.authorParmar, Mahesh K.B.
dc.contributor.authorLarkin, James
dc.contributor.authorMeade, Angela
dc.date.accessioned2021-09-22T11:30:13Z
dc.date.available2021-09-22T11:30:13Z
dc.date.issued2021-09
dc.identifier.citationOza , B , Frangou , E , Smith , B , Bryant , H , Kaplan , R , Choodari-Oskooei , B , Powles , T , Stewart , G D , Albiges , L , Bex , A , Choueiri , T K , Davis , I D , Eisen , T , Fielding , A , Harrison , D , McWhirter , A , Mulhere , S , Nathan , P , Rini , B , Ritchie , A , Scovell , S , Shakeshaft , C , Stockler , M R , Thorogood , N , Parmar , M K B , Larkin , J & Meade , A 2021 , ' RAMPART : a phase III multi-arm multi-stage trial of adjuvant checkpoint inhibitors in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse ' , Contemporary Clinical Trials , vol. 108 , 106482 . https://doi.org/10.1016/j.cct.2021.106482en
dc.identifier.issn1551-7144
dc.identifier.otherPURE: 275967790
dc.identifier.otherPURE UUID: 8e8a5978-c1a8-4416-b4be-9bacbd186e98
dc.identifier.otherRIS: urn:AE2FBF2628FE3CC3FFA40F93E0271A85
dc.identifier.otherScopus: 85114992124
dc.identifier.otherORCID: /0000-0001-9041-9988/work/100549688
dc.identifier.urihttp://hdl.handle.net/10023/23999
dc.descriptionAstraZeneca LP have provided an educational grant for the trial and free of charge durvalumab and tremelimumab. A small grant is also provided by Kidney Cancer UK. MRC CTU at UCL also provides funding for staff working on the trial. The TransRAMPART sample collection is being funded by a Prospective Sample Collection award from Cancer Research UK.en
dc.description.abstractBackground 20–60% of patients with initially locally advanced Renal Cell Carcinoma (RCC) develop metastatic disease despite optimal surgical excision. Adjuvant strategies have been tested in RCC including cytokines, radiotherapy, hormones and oral tyrosine-kinase inhibitors (TKIs), with limited success. The predominant global standard-of-care after nephrectomy remains active monitoring. Immune checkpoint inhibitors (ICIs) are effective in the treatment of metastatic RCC; RAMPART will investigate these agents in the adjuvant setting. Methods/design RAMPART is an international, UK-led trial investigating the addition of ICIs after nephrectomy in patients with resected locally advanced RCC. RAMPART is a multi-arm multi-stage (MAMS) platform trial, upon which additional research questions may be addressed over time. The target population is patients with histologically proven resected locally advanced RCC (clear cell and non-clear cell histological subtypes), with no residual macroscopic disease, who are at high or intermediate risk of relapse (Leibovich score 3–11). Patients with fully resected synchronous ipsilateral adrenal metastases are included. Participants are randomly assigned (3,2:2) to Arm A - active monitoring (no placebo) for one year, Arm B - durvalumab (PD-L1 inhibitor) 4-weekly for one year; or Arm C - combination therapy with durvalumab 4-weekly for one year plus two doses of tremelimumab (CTLA-4 inhibitor) at day 1 of the first two 4-weekly cycles. The co-primary outcomes are disease-free-survival (DFS) and overall survival (OS). Secondary outcomes include safety, metastasis-free survival, RCC specific survival, quality of life, and patient and clinician preferences. Tumour tissue, plasma and urine are collected for molecular analysis (TransRAMPART).
dc.format.extent9
dc.language.isoeng
dc.relation.ispartofContemporary Clinical Trialsen
dc.rightsCopyright © 2021 Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license.en
dc.subjectRAMPARTen
dc.subjectRenal canceren
dc.subjectDurvalumaben
dc.subjectTremelimumaben
dc.subjectMAMSen
dc.subjectPlatform trialen
dc.subjectCheck-point inhibitoren
dc.subjectRC0254 Neoplasms. Tumors. Oncology (including Cancer)en
dc.subjectRM Therapeutics. Pharmacologyen
dc.subject3rd-DASen
dc.subject.lccRC0254en
dc.subject.lccRMen
dc.titleRAMPART : a phase III multi-arm multi-stage trial of adjuvant checkpoint inhibitors in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapseen
dc.typeJournal articleen
dc.description.versionPublisher PDFen
dc.contributor.institutionUniversity of St Andrews.School of Medicineen
dc.contributor.institutionUniversity of St Andrews.Sir James Mackenzie Institute for Early Diagnosisen
dc.contributor.institutionUniversity of St Andrews.Cellular Medicine Divisionen
dc.identifier.doihttps://doi.org/10.1016/j.cct.2021.106482
dc.description.statusPeer revieweden


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