ClinicaliQ Trial Snapshot
- WIRE – Novel Treatments in Renal Cell Cancer — Recruiting • Phase II • Oncology • NCT03741426.
- What is being tested: Novel immunomodulatory therapies (IMPs) administered as monotherapy or combination therapy in a "window of opportunity" period before surgical removal of the kidney, with assessment of mechanism of action via ktrans imaging and CD8+ T cell infiltration.
- Patient eligibility overview: Patients with surgically resectable renal cell carcinoma who have a defined interval between diagnosis and scheduled nephrectomy, allowing time for preoperative treatment administration and tumour response evaluation.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
Evaluation of proof of mechanism with relation to ktrans and/or CD8 count when 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
Eligibility Snapshot
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * Aged ≥18 years and over. * Predicted life expectancy ≥ 16 weeks. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. * Have biopsy proven clear cell RCC, either as part of the screening process or if undertaken prior to screening no more than 6 weeks prior to consent. * Allow access to archival Formalin-Fixed Paraffin-Embedded (FFPE) tumour tissue from any previous renal tumour biopsy * Have a surgically resectable tumour as determined by the treating urologist * T1b or above, N0 and M0; OR have any T status where either N1 or M1 (but the participant must be deemed suitable for cytoreductive nephrectomy at time of enrolment). * No prior exposure to PARP inhibitors (including but not limited to olaparib), tyrosine kinase inhibitors (including but not limited to cediranib, sunitinib, pazopanib, axitinib, bevacizumab and cabozantinib), immunotherapy or immune checkpoint inhibitors (including but not limited to other anti-CTLA-4, anti-TIGIT, anti-PD-1, or anti-PD-L1 antibodies), nor prior treatment with a mammalian target of rapamycin (mTOR) inhibitor (including, but not limited to…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.