dc.contributor.author | Oza, B | |
dc.contributor.author | Frangou, E | |
dc.contributor.author | Smith, B | |
dc.contributor.author | Bryant, H | |
dc.contributor.author | Kaplan, R | |
dc.contributor.author | Choodari-Oskooei, B | |
dc.contributor.author | Powles, T | |
dc.contributor.author | Stewart, GD | |
dc.contributor.author | Albiges, L | |
dc.contributor.author | Bex, A | |
dc.contributor.author | Choueiri, TK | |
dc.contributor.author | Davis, ID | |
dc.contributor.author | Eisen, T | |
dc.contributor.author | Fielding, A | |
dc.contributor.author | Harrison, D | |
dc.contributor.author | McWhirter, A | |
dc.contributor.author | Mulhere, S | |
dc.contributor.author | Nathan, P | |
dc.contributor.author | Rini, B | |
dc.contributor.author | Ritchie, A | |
dc.contributor.author | Scovell, S | |
dc.contributor.author | Shakeshaft, C | |
dc.contributor.author | Stockler, MR | |
dc.contributor.author | Thorogood, N | |
dc.contributor.author | Parmar, MKB | |
dc.contributor.author | Larkin, J | |
dc.contributor.author | Meade, A | |
dc.coverage.spatial | United States | |
dc.date.accessioned | 2022-08-30T09:37:03Z | |
dc.date.available | 2022-08-30T09:37:03Z | |
dc.date.issued | 2021-09-16 | |
dc.identifier | ARTN 106482 | |
dc.identifier | S1551-7144(21)00218-4 | |
dc.identifier.citation | Contemporary Clinical Trials, 2021, 108 pp. 106482 - | en_US |
dc.identifier.issn | 1551-7144 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5341 | |
dc.identifier.eissn | 1559-2030 | |
dc.identifier.eissn | 1559-2030 | |
dc.identifier.doi | 10.1016/j.cct.2021.106482 | |
dc.description.abstract | BACKGROUND: 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). TRIAL REGISTRATION: ISRCTN #: ISRCTN53348826, NCT #: NCT03288532, EUDRACT #: 2017-002329-39, CTA #: 20363/0380/001-0001, MREC #: 17/LO/1875, ClinicalTrials.gov Identifier: NCT03288532, RAMPART grant number: MC_UU_12023/25, TransRAMPART grant number: A28690 Cancer Research UK, RAMPART Protocol version 5.0. | |
dc.format | Print-Electronic | |
dc.format.extent | 106482 - | |
dc.language | eng | |
dc.language.iso | eng | en_US |
dc.publisher | ELSEVIER SCIENCE INC | en_US |
dc.relation.ispartof | Contemporary Clinical Trials | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | en_US |
dc.subject | Check-point inhibitor | |
dc.subject | Durvalumab | |
dc.subject | MAMS | |
dc.subject | Platform trial | |
dc.subject | RAMPART | |
dc.subject | Renal cancer | |
dc.subject | Tremelimumab | |
dc.subject | Carcinoma, Renal Cell | |
dc.subject | Chronic Disease | |
dc.subject | Humans | |
dc.subject | Kidney Neoplasms | |
dc.subject | Quality of Life | |
dc.subject | Recurrence | |
dc.title | 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. | en_US |
dc.type | Journal Article | |
dcterms.dateAccepted | 2021-06-09 | |
dc.date.updated | 2022-08-30T09:36:17Z | |
rioxxterms.version | VoR | en_US |
rioxxterms.versionofrecord | 10.1016/j.cct.2021.106482 | en_US |
rioxxterms.licenseref.startdate | 2021-09-16 | |
rioxxterms.type | Journal Article/Review | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/34538402 | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer/Melanoma and Kidney Cancer (hon.) | |
pubs.publication-status | Published | |
pubs.volume | 108 | |
dc.contributor.icrauthor | Larkin, James | |
icr.provenance | Deposited by Mr Arek Surman on 2022-08-30. Deposit type is initial. No. of files: 1. Files: RAMPART A phase III multi-arm multi-stage trial of adjuvant checkpoint inhibitors in patients with resected primary renal ce.pdf | |