EUCTR2016-000706-12-CZ进行中（未招募）1 期
A Phase 2, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab Versus Standard of Care in Subjects with Previously Untreated and Advanced (unresectable or metastatic) non-clear Cell Renal Cell Carcinoma - SUNNIFORECAST
Goethe University Frankfurt0 个研究点目标入组 306 人开始时间: 2017年4月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 306
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
- •1. Signed Written Informed Consent
- •a) Subjects must have signed and dated an IRB/IEC approved
- •written informed consent form in accordance with regulatory and
- •institutional guidelines. This must be obtained before the
- •performance of any protocol related procedures that are not part
- •of normal subject care.
- •b) Subjects must be willing and able to comply with scheduled
- •visits, treatment schedule, laboratory testing, and other
- •requirements of the study.
- •2. Target Population
- •a) Histological confirmation of non-clear RCC with at least 50%
- •non-clear cell component according to actual WHO
- •classification36
- •b) Advanced (not amenable to curative surgery or radiation therapy)
- •or metastatic (AJCC Stage IV) RCC
- •c) Karnofsky > 70%
- •d) Measurable disease as per RECIST v 1.1 documented by an
- •English radiology report
- •e) Tumor tissue (FFPE archival or recent acquisition) must be
- •available and sent to the central pathological in order to confirm
- •the diagnosis. (Note: Fine Needle Aspiration [FNA] and bone
- •metastases samples are not acceptable for submission).
- •f) Patients with all risk categories will be eligible for the study.
- •Patients will be stratified for papillary or non-papillary non-clear
- •cell histology and IMDC risk score Patients will be categorized
- •according to favorable versus intermediate versus poor risk status
- •at registration according to the International Metastatic RCC
- •Database Consortium (IMDC) criteria:
- •i. KPS equal to 70%
- •ii. Less than 1 year from diagnosis to randomization
- •iii. Hemoglobin less than the lower limit of normal (LLN)
- •iv. Corrected calcium concentration greater than the upper limit of normal (ULN)
- •v. Absolute neutrophil count greater than the ULN
- •vi. Platelet count greater than the ULN
- •If none of the above factors are present, subjects are only eligible for the
- •favorable-risk cohort, if 1-2 factors are present subjects are categorized
- •as intermediate risk and > 3 factors as poor risk.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. Target Disease Exceptions
- •a) Any active brain metastases requiring systemic corticosteroids.
- •Baseline imaging of the brain by MRI is required in patients with
- •clinical signs of potential CNS involvement within 28 days prior
- •to randomization.
- •b) Tumors with a clear-cell component of > 50%
- •Medical History and Concurrent Diseases
- •c) Prior systemic treatment with VEGF or VEGF receptor targeted
- •therapy (including, but not limited to, Sunitinib, pazopanib,
- •axitinib, tivozanib, and bevacizumab) or prior treatment with an
- •mTOR inhibitor or cytokines.
- •d) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-
- •CD137, or anti-CTLA-4 antibody, or any other antibody or drug
- •specifically targeting T-cell co-stimulation or checkpoint
- •e) Administration of an immune checkpoint inhibitor as standard of
- •f) Any active or recent history of a known or suspected
- •autoimmune disease or recent history of a syndrome that required
- •systemic corticosteroids (> 10 mg daily prednisone equivalent) or
- •immunosuppressive medications except for syndromes which
- •would not be expected to recur in the absence of an external
- •trigger. Subjects with vitiligo or type I diabetes mellitus or
- •residual hypothyroidism due to autoimmune thyroiditis only
- •requiring hormone replacement are permitted to enroll.
- •g) Any condition requiring systemic treatment with corticosteroids
- •(> 10 mg daily prednisone equivalents) or other
- •immunosuppressive medications within 14 days prior to first
- •dose of study drug. Inhaled steroids and adrenal replacement
- •steroid doses > 10 mg daily prednisone equivalents are permitted
- •in the absence of active autoimmune disease.
- •h) Uncontrolled adrenal insufficiency.
- •i) Ongoing symptomatic cardiac dysrhythmias, uncontrolled atrial
- •fibrillation, or prolongation of the Fridericia corrected QT
- •(QTcF) interval defined as > 450 msec for males and > 470 msec
- •for females, where QTcF = QT / 3vRR
- •j) Poorly controlled hypertension (defined as systolic blood pressure (SBP) of ??150 mmHg or diastolic blood pressure
- •(DBP) of ??90 mmHg), despite antihypertensive therapy.
- •k) History of any of the following cardiovascular conditions within
- •12 months of enrollment: cardiac angioplasty or stenting,
- •myocardial infarction, unstable angina, coronary artery by-pass
- •graft surgery, symptomatic peripheral vascular disease, class III
- •or IV congestive heart failure, as defined by the New York Heart
- •Association.
- •l) History of cerebrovascular accident including transient ischemic
- •attack within the past 12 months.
- •m) History of deep vein thrombosis (DVT) unless adequately treated
- •with low molecular weight heparin
- •n) History of pulmonary embolism within the past 6 months unless
- •stable, asymptomatic, and treated with low molecular weight
- •heparin for at least 6 weeks.
- •o) History of abdominal fistula, gastrointestinal perforation, or
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