WIRE - Novel Treatments in Renal Cell Cancer

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

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Study’s contact

Call center

01223 256364

Email address

cctu.cancer@addenbrookes.nhs.uk

Condition

Renal Cell Cancer

Treatment type

Interventional

Investigational product

Cediranib

Phase

Phase 2

Sponsor

Cambridge University Hospitals NHS Foundation Trust

ClinicalTrials.gov identifier

NCT03741426

Study number

WIRE

Understanding clinical trials

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About the study

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

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion 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

Exclusion criteria

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

  1. and absence of hepatitis B surface antigen -HbsAg-) are eligible. As judged by the Investigator, any patient considered a poor medical risk due to a serious uncontrolled medical or psychiatric disorder, non-malignant systemic disease or on-going or active infection. Persistent toxicities (≥Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia and vitiligo. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician. For Durvalumab-containing arms only: Patient with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the investigator. Women who are pregnant, or are lactating or breastfeeding. Women of childbearing potential and male participants who are unwilling to use adequate contraception from screening and for 180 days after the last dose of study drug. Patients with contraindication to MRI including; contraindicated metallic implants, contraindicated coronary stents and pacemakers. Inability to lie flat or still in an MRI scanner for whatever reason (e.g. claustrophobia) Judgement by the Investigator that the patient should not participate in the trial.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

Find a Study Site

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