ACTRN12617000741381已完成1 期
ivolumab in renal transplant recipients with poor prognosis cancers - a safety study.
Central Northern Adelaide Local Health Network, Royal Adelaide Hospital0 个研究点目标入组 22 人开始时间: 2017年5月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •*Patient has provided written informed consent prior to initiation of any study specific activities/procedures.
- •*Recipient of renal transplant aged 18 years or older more than 3 months post-transplant
- •*Recipients of multiple renal transplants will be allowed
- •*Incurable locally advanced or metastatic, histologically proven tumours, progressing on standard first line therapy or metastatic solid tumours requiring palliative treatment (the latter group of patients are not required to have had prior anti-cancer therapy) or in-operable tumours where standard curative treatment approaches will either have failed or are not applicable.
- •*ECOG 0-1 and 2 by discussion with medical monitor
- •*Disease that is measurable by RECIST
- •*Eligible tumour types include:
- •a. SCC of the skin
- •b. SCC of head and neck
- •c. Melanoma
- •d. Merkel Cell Carcinoma
- •e. NSCLC Lung cancer
- •f. Urothelial cancer
- •g. Colorectal cancer which is MSI-H
- •.h. Breast cancer (triple negative)
- •i. Any other solid tumour which is MSI-H
- •j. Any tumour which is deemed to be sensitive to PD-1 blockade
- •*Co-morbid conditions are stable
- •*Life expectancy >3 months
- •*Patient has adequate organ and bone marrow function within 14 days of study entry
- •a. Neutrophil count >1.5 x109/L
- •b. Platelets >100 x109/L
- •c. Hb >80g/L
- •d. Total bilirubin <1.5 upper limit of normal, (ULN)
- •e. ALT and AST <3.0 x ULN
- •f. Serum creatinine <1.5 x ULN
- •g. PT and APTT <1.3 x ULN
- •*Willing to stay on, restart or have no contraindications to immunosuppressive agents including calcineurin inhibitors, antiproliferative agents and prednisolone if deemed appropriate by the study investigators.
- •*For females of reproductive potential-negative pregnancy test prior to study entry and use of highly effective contraception
- •*For males of reproductive potential: use of condoms
排除标准
- •An individual who meets any of the following criteria will be excluded from participation:
- •*Within 3 months of transplantation and at the time of initiation of Nivolumab.
- •*Unable to provide informed consent
- •*Not prepared or unable to re-join a renal dialysis program
- •*Unable to undertake monitoring for signs of rejection, toxicity or anti-tumour effect
- •*The patient has uncontrolled or significant intercurrent or recent illness including:
- •a) Auto-immune disorder or uncontrolled endocrinopathy
- •b) Cardiac disorder such as uncontrolled cardiac failure, unstable angina or NSTEMI or myocardial infarction, uncontrolled arrhythmia
- •c) Stroke or thromboembolic event within 3 months of study commencement
- •d) Active or uncontrolled severe infection
- •e) Active coagulopathy/bleeding diathesis
- •f) Cirrhosis, chronic active or untreated persistent hepatitis
- •* The patient is pregnant or lactating
- •* The patient doesn’t agree to use highly effective methods of contraception.
- •* Prisoners or subjects who are involuntarily incarcerated
- •* Subjects who are compulsorily detained for treatment of either a psychiatric or
- •physical (eg, infectious disease) illness
- •* Donor specific antibody with MFI >4000 units
研究者
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