WIRE - Novel Treatments in Renal Cell Cancer — WIRE  

Renal Cell Cancer Clinical Trial

Official title: WIndow of Opportunity Clinical Trials Platform for Evaluation of Novel Treatments Strategies in REnal Cell Cancer

Status Recruiting

Clinical Trial Summary

Evaluation of proof of mechanism with relation to ktrans and/or CD8 count when 3 different IMPs are given as monotherapy or as combination therapy. These would be administered in the "window of opportunity", prior to nephrectomy in surgically resectable renal cell cancer

Clinical Trial Description

A Phase 2, multi-arm, multicentre, non-randomised, proof-of-mechanism (single and combination IMPs) trial using a Bayesian adaptive design.

A multi-centre trial. 2 centres initially planned - this may be reduced or increased in order to recruit the required number of participants.

Up to sixty (60) patients with surgically resectable renal cell cancer (Stage M0/M1). Up to twelve (12) participants will be registered for each of the single treatment arms and up to twenty (20) participants for the combination treatment arm(s) as per the Bayesian adaptive design.

The trial duration consists of a 28 day screening period, a minimum of 2 weeks oral IMP (Olaparib and/or Cediranib) treatment or a single dose of durvalumab alone or in combination in the window-of-opportunity period prior to surgery (nephrectomy or partial nephrectomy) performed as standard of care.

Participants will continue oral IMP treatment up until surgery (stopping when indicated for surgical safety reasons). As such treatment duration will be variable and an optional 21 day telephone assessment will take place for patients who remain on IMP. Patients will then be reviewed in the surgical follow-up clinic at 6 weeks and 3 months post-surgery as standard of care.

For patients on monotherapy or combination Olaparib and Cediranib IMP, response will be measured using DCE-MRI (Ktrans), defining reduced tumour capillary permeability.

For patients on monotherapy Durvalumab, or combination Olaparib and Durvalumab, response will be measured using CD8 positive T cells.

Additional safety outcomes will be assessed, along with the tumour response and various biological measures that would indicate drug mechanistic response. ;

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Cancer

• NCT number: NCT03741426
• Study type: Interventional
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: CCTU Cancer Theme
• Phone: 01223 256364
• Email: cctu.cancer@addenbrookes.nhs.uk
• Status: Recruiting
• Phase: Phase 2
• Start date: July 27, 2020
• Completion date: November 30, 2025