Window-of-opportunity clinical trials platform for evaluation of novel treatment strategies in renal cell cancer. - WIRE

Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge0 sites76 target enrollmentAugust 5, 2019

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Surgically resectable renal cell cancer (Stage M0/M1)
Sponsor: Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Enrollment: 76
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

August 5, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge

•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.
••Allow access to archival FFPE tumour tissue from biopsy and nephrectomy.
••Have a surgically resectable tumour as determined by the treating Urologist
•T1b or above, any N status, M0, OR have any T or N status, M1 (but if M1, the participant must be deemed suitable for cytoreductive nephrectomy at time of enrolment).
•No prior exposure to PARP inhibitors, tyrosine kinase inhibitors, immunotherapy or immune checkpoint inhibitors, nor prior treatment with an mammalian target of rapamycin (mTOR) inhibitor. Prior cytokine therapy (eg, IL\-2, IFN\-a) or treatment with cytotoxics is allowed.
•At least 1 measurable lesion according to RECIST Version 1\.1 at screening that can be accurately assessed at by MRI and is suitable for repeated assessment.

•cT1a N0 M0\-staged Renal Cell Cancer
•Participants with brain metastases. A scan to confirm the absence of brain metastases is not required.
•Participants with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days prior to start of treatment.
•History of leptomeningeal carcinomatosis.
•Body weight \=30kg
•Contraindication to cediranib, olaparib, durvalumab or chimeric or humanized antibodies or fusion proteins.
•Specifically participants with hereditary galactose intolerance, Lapp lactase deficiency or glucose\-galactose malabsorption should not enter the trial.
•History of hypersensitivity to active or inactive excipients of cediranib, olaparib or durvalumab.
•Other invasive malignancy within the last 2 years. Participants with previous history of malignancies with a negligible risk of metastasis or death and treated with expected curative intent are eligible at discretion of clinical team\- examples in Protocol\- word count
•Major surgery within 4 weeks prior to first dose of trial drug (excluding placement of vascular access). If patientparticipants have undergone major surgery more than 4 weeks prior to the scheduled first dose of studytrial drug, they must have fully recovered from the procedure.