NCT03741426

WIRE - Novel Treatments in Renal Cell Cancer

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: CCTU- Cancer Theme · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Renal Cell Cancer

Interventions

Type	Name	Description
DRUG	Olaparib	Olaparib 300mg twice daily, oral medication administered for at least 2 weeks and up until the morning of nephrectomy. Arms 2, 3 and 5
DRUG	Cediranib	Cediranib 20mg once daily, oral medication administered for at least 2 weeks until 36 hours prior to nephrectomy. Arms 1 and 3
DRUG	Durvalumab	Durvalumab 1500mg intravenous infusion administered once, no greater than 4 weeks prior to nephrectomy

Timeline

• Start date: 2020-07-27
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2018-11-14
• Last updated: 2023-06-07

Locations

2 sites across 1 country: United Kingdom