biostudies-literatureUrsprung SCancer Research UKMedical Research CouncilNIHR Cambridge Biomedical Research CentreAstraZenecaCancer Research UK Cambridge Centre1238https://www.ebi.ac.uk/biostudies/studies/S-EPMC8600815biostudies-literatureUnknown21(1)<h4>Background</h4>Window-of-opportunity trials, evaluating the engagement of drugs with their biological target in the time period between diagnosis and standard-of-care treatment, can help prioritise promising new systemic treatments for later-phase clinical trials. Renal cell carcinoma (RCC), the 7^th commonest solid cancer in the UK, exhibits targets for multiple new systemic anti-cancer agents including DNA damage response inhibitors, agents targeting vascular pathways and immune checkpoint inhibitors. Here we present the trial protocol for the WIndow-of-opportunity clinical trial platform for evaluation of novel treatment strategies in REnal cell cancer (WIRE).<h4>Methods</h4>WIRE is a Phase II, multi-arm, multi-centre, non-randomised, proof-of-mechanism (single and combinaBMC cancerThe WIRE study a phase II, multi-arm, multi-centre, non-randomised window-of-opportunity clinical trial platform using a Bayesian adaptive design for proof-of-mechanism of novel treatment strategies in operable renal cell cancer - a study protocol.PMC860081527176MR/T024097/1C9685/A25177MC_UU_00002/627150BRC-1215-20014Ursprung SWarren AYSkells RMatakidou ASala EOades GSullivan MFife KYoung GStone JMitchell TJSipple JANWelsh SJGallagher FAOrtuzar MCEisen TWalker AThomas MGProtheroe AVenugopal BStewart GDWason JMossop HChhabra AfalseThe WIRE study a phase II, multi-arm, multi-centre, non-randomised window-of-opportunity clinical trial platform using a Bayesian adaptive design for proof-of-mechanism of novel treatment strategies in operable renal cell cancer - a study protocol.<h4>Background</h4>Window-of-opportunity trials, evaluating the engagement of drugs with their biological target in the time period between diagnosis and standard-of-care treatment, can help prioritise promising new systemic treatments for later-phase clinical trials. Renal cell carcinoma (RCC), the 7^th commonest solid cancer in the UK, exhibits targets for multiple new systemic anti-cancer agents including DNA damage response inhibitors, agents targeting vascular pathways and immune checkpoint inhibitors. Here we present the trial protocol for the WIndow-of-opportunity clinical trial platform for evaluation of novel treatment strategies in REnal cell cancer (WIRE).<h4>Methods</h4>WIRE is a Phase II, multi-arm, multi-centre, non-randomised, proof-of-mechanism (single and combina2021-01-01T00:00:00Z2021 Nov2026-05-08T12:07:36.002Z2022-02-11T13:03:47.383ZS-EPMC86008153479441210.1186/s12885-021-08965-4