EUCTR2016-000706-12-ES进行中（未招募）1 期
A Phase 2, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab Versus Sunitinib Monotherapy 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5月31日最近更新:
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% (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) 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 catogerized as intermediate risk and > 3 factors as poor risk.
- •3. Age and Reproductive Status
- •a) Males and Females, ? 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.
- •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 Sunitinib should use an adequate method to avoid pregnancy for 8 weeks (30 days plus the time required for the active metabolite of Sunitinib 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 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
排除标准
- •1) Any active brain metastases requiring systemic corticosteroids.
- •2) Tumors with a clear-cell component of > 50% Medical History and Concurrent Diseases
- •3) 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.
- •4) 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.
- •5) 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.
- •6) 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.
- •7) Uncontrolled adrenal insufficiency.
- •8) 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
- •9) Poorly controlled hypertension (defined as systolic blood pressure (SBP) of = 150 mmHg or diastolic blood pressure (DBP) of = 90 mmHg), despite antihypertensive therapy.
- •10) 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.
- •11) History of cerebrovascular accident including transient ischemic attack within the past 12 months.
- •12) History of deep vein thrombosis (DVT) unless adequately treated with low molecular weight heparin
- •13) History of pulmonary embolism within the past 6 months unless stable, asymptomatic, and treated with low molecular weight heparin for at least 6 weeks.
- •14) History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months.
- •15) Serious, non-healing wound or ulcer.
- •16) Evidence of active bleeding or bleeding susceptibility; or medically significant hemorrhage within prior 30 days.
- •17) Any requirement for anti-coagulation, except for low molecular weight heparin.
- •18) 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.
- •19) Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- •20) Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.
- •21) Known medical condition (eg, a condition associated with diarrhea or acute diverticulitis) that, in the investigator’s op
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