EUCTR2016-000706-12-FR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: 2018年3月6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 classification
- •b) Advanced (not amenable to curative surgery or radiation therapy) or metastatic
- •(AJCC Stage IV) RCC
- •c) Karnofsky > 70% (See Appendix 2, 14.2)
- •d) Measurable disease as per RECIST v 1.1 (See Appendix 3, 14.3) documented by an English
- •radiology report
- •e) Tumor tissue (FFPE archival or recent acquisition) must be available and sent to the central
- •pathological reviewer (see Table 6) 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)
- •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 catogerized as intermediate risk and > 3 factors as poor risk.
- •3. Age and Reproductive Status
- •a) Males and Females, greater than or equal 18 years of age
- •b) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25
- •IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
- •c) Women must not be breastfeeding
- •d) WOCBP must agree to follow instructions for method(s) of contraception for a period of
- •30 days (duration of ovulatory cycle) plus the time required for the investigational drug to
- •undergo five half-lives. The terminal half-lives of Nivolumab and Ipilimumab are up to
- •25 days and 18 days, respectively. The terminal half-life of the active metabolite of
- •Sunitinib is up to 110 hours. The terminal half-life of other standard of care agents has to
- •be derived from the product information.
- •i. WOCBP randomized to receive Nivolumab + Ipilimumab should use an adequate
- •method to avoid pregnancy for 23 weeks (30 days plus the time required for
- •Nivolumab to undergo five half-lives) after the last dose of investigational drug.
- •ii. WOCBP randomized to receive a standard of care agent should use an adequate
- •method to avoid pregnancy for at least 8 weeks (30 days plus the time required for
- •the active metabolite of the standard of care agent to undergo five half-lives)
- •e) Males who are sexually active with WOCBP must agree to follow instructions for
- •method(s) of contraception for a period of 90 days (duration of sperm turnover) plus the
- •time required for the investigational drug to undergo five half-lives. The
排除标准
- •Exclusion Criteria
- •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 pathways.
- •e) 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.
- •f) 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.
- •g) Uncontrolled adrenal insufficiency.
- •h) 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
- •i) Poorly controlled hypertension (defined as systolic blood pressure (SBP) of ? 150 mmHg
- •or diastolic blood pressure (DBP) of ? 90 mmHg), despite antihypertensive therapy.
- •j) 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.
- •k) History of cerebrovascular accident including transient ischemic attack within the past
- •l) History of deep vein thrombosis (DVT) unless adequately treated with low molecular
- •weight heparin
- •m) History of pulmonary embolism within the past 6 months unless stable, asymptomatic,
- •and treated with low molecular weight heparin for at least 6 weeks.
- •n) History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
- •within the past 6 months.
- •o) Serious, non-healing wound or ulcer.
- •p) Evidence of active bleeding or bleeding susceptibility; or medically significant
- •hemorrhage within prior 30 days.
- •q) Any requirement for anti-coagulation, except for low molecular weight heparin.
- •r) Prior malignancy active within the previous 3 years except for locally curable cancers
- •that have been apparently cured, such as basal or squamous cell skin cancer, superficial
- •bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- •s) Known history of testing positive for human immunodeficiency virus (HIV) or known
- •acquired immunodeficiency syndrome (AIDS).
- •t) Any positive test for hepatitis B or
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