WIRE - Novel Treatments in Renal Cell Cancer
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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
You may be eligible to participate in the study if you meet the following criteria:
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 ≥ 3 months. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. Have biopsy proven clear cell RCC. Have a surgically resectable tumour as determined by the treating Urologist Have any T or N status, M0. Have any T or N status, M1 (but if M1, the subject 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 or cabozantinib), immunotherapy or immune checkpoint inhibitors (including but not limited to other anti
Patients with brain metastases. A scan to confirm the absence of brain metastases is not required. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days. History of leptomeningeal carcinomatosis. Body weight <30kg Contraindication to cediranib, olaparib, durvalumab or chimeric or humanized antibodies or fusion proteins. Specifically patients with hereditary galactose intolerance, Lapp lactase deficiency or glucose
For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov
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