EUCTR2018-003056-21-GB进行中（未招募）1 期
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 个研究点目标入组 76 人开始时间: 2019年8月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 76
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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.
- •Have adequate organ and marrow function
- •Creatinine clearance =30mL/min (calculated by Cockcroft and Gault equation
- •Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause (Protocol has further details of what this means- word count)
- •For women of childbearing potential a negative serum pregnancy test must be performed within 28 days of study treatment and confirmed prior to treatment on day 1.
- •Male patients must be willing to use a condom during treatment and for 3 months after the last dose of trial treatment when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also be willing to use a highly effective form of contraception if they are of childbearing potential
- •Patient is willing and able to comply with the protocol for the duration of the trial.
- •Adequately controlled thyroid function, with no symptoms of thyroid dysfunction
- •Some drug-specific Inclusion criteria apply, truncated due to word count
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 38
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
排除标准
- •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.
- •Minor surgery (not including the diagnostic biopsy) within 2 weeks prior to first dose of trial treatment
- •Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- •Concurrent enrolment in another clinical trial unless it is an observational (non-interventional NOT involving CTIMPs) or translational clinical trial, or during the follow-up period of an interventional clinical trial.
- •Receipt of the last dose of anticancer therapy or radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumour embolisation, monoclonal antibodies) =28 days prior to the first dose of trial drug.
- •Gastrointestinal abnormalities- see Protocol (word count)
- •Any of the following within 12 months prior to trial entry:
- •omyocardial infarction,
- •ouncontrolled angina,
- •ocoronary/peripheral artery bypass graft,
- •osymptomatic congestive heart failure,
- •ocerebrovascular accident or transient ischemic attack,
- •operipheral arterial embolus.
- •Current or prior use of immunosuppressive agents within 28 days prior to the of first day of trial drug, including anti-TNF and anti-IL17 agents, with the exceptions of intranasal or inhaled corticosteroids, or systemic corticosteroids at physiological doses which are not to exceed 10mg/day prednisolone (or an equivalent corticosteroid). See Protocol for exceptions (word count)
- •Immunocompromised participants (e.g., participants who are known to be serologically positive for human immunodeficiency virus (HIV), or have a history of active primary immunodeficiency).
- •Active infection including tuberculosis (clinical history, physical examination and radiographic findings, and Tuberculosis (TB) testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV1/2 antibodies).
- •oParticipants with a past or resolved HBV infection (defined as: presence of hepatitis B core antibody -anti-HBc- and absence of hepatitis B surface antigen –HbsAg-) are e
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