EUCTR2012-000871-17-IT进行中（未招募）1 期
An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT) - ADAPT
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
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. Age = 18 years
- •2. Advanced disease, histologically assessed as RCC, with a component of clear cell histology
- •3. Measurable metastatic disease that can be monitored throughout the course of the study participation per RECIST 1.1
- •4. Subjects who are candidates for a first-line therapy initiating with sunitinib
- •5. Time from diagnosis to treatment <1 year
- •6. Karnofsky Performance Status (KPS) = 80%
- •7. Life expectancy of 6 months or greater
- •8. Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to Grade = 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
- •9. Adequate hematologic function, as defined by the following criteria (per the central lab):
- •a. Absolute neutrophil count (ANC) = LLN
- •b. Platelets = LLN
- •c. Hemoglobin (Hgb) = 9.0 g/dL
- •10. Adequate renal and hepatic function, as defined by the following criteria:
- •a. Serum creatinine = 1.5 x upper limit of normal (ULN)
- •- or, if serum creatinine > 1.5 x ULN, estimated glomerular filtration rate (eGFR) = 30 mL/min
- •b. Total serum bilirubin = 1.5 x ULN
- •c. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN
- •- or, AST and ALT = 5 x ULN if liver function abnormalities are due to underlying malignancy
- •11. Adequate coagulation function as defined by the following criteria:
- •a. Corrected calcium = 11.5 mg/dL
- •b. Activated partial thromboplastin time (PTT) < 1.5 x ULN
- •12. Negative serum pregnancy test for female subjects with reproductive potential, and agreement of all male and female subjects of reproductive potential to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug
- •13. Normal ECG or clinically non-significant finding(s) at Screening
- •14. Able to abstain from taking prohibited drugs, either prescription or non-prescription, during the treatment phase of the study
- •15. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- •16. Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
- •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 315
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 135
排除标准
- •1. Prior systemic therapy (including adjuvant or neoadjuvant) of any kind for RCC, including immunotherapy, chemotherapy, hormonal, or investigational therapy
- •2. Prior history of malignancy other than RCC within the preceding 3 years, except for adequately treated in situ carcinomas or non-melanoma skin cancer
- •3. History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease
- •4. Patients will be excluded if they have 5 or more of the following risk factors at Screening:
- •a. Time from diagnosis to treatment <1 year
- •b. Hgb < LLN
- •c. Corrected calcium > 10.0 mg/dL
- •d. KPS < 80%
- •e. Neutrophils > ULN
- •f. Platelets > ULN
- •- Note: Per inclusion criteria, eligible subjects will have a time from diagnosis to treatment of < 1 year and must have good performance status (eg., KPS = 80%).
- •5. Planned or elective surgical treatment or radiation therapy post-nephrectomy within 28 days before Visit 1 (Day 0)
- •- NOTE: Palliative radiotherapy to metastatic lesion(s) is permitted if it is completed > 28 days before Visit 1 (Day 0) and provided there is at least one measurable lesion that has not been irradiated.
- •6. NCI CTCAE Grade 3 hemorrhage < 28 days before Visit 1 (Day 0)
- •7. Clinically significant cardiovascular conditions within 3 months prior to Randomization, including:
- •a. Cardiac angioplasty
- •b. Myocardial infarction
- •c. Unstable angina
- •d. Coronary artery by-pass graft or stenting
- •e. Class III or IV congestive heart failure (CHF)
- •f. Symptomatic peripheral vascular disease
- •g. Cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- •h. Pulmonary embolism or deep vein thrombosis (DVT)
- •i. Ongoing cardiac dysrhythmias of NCI CTCAE Grade = 2, atrial fibrillation of any grade, or prolongation of the QTc for males > 450 msec and for females > 470 msec as corrected by either the Fridericia or Bazett formula
- •j. Left ventricular ejection fraction (LVEF) < LLN as assessed by either echocardiography or multiple gated acquisition (MUGA) scan
- •k. Poorly controlled hypertension, defined as a systolic blood pressure (SBP) = 150 mm Hg or diastolic blood pressure (DBP) = 90 mm Hg
- •- NOTE: Initiation of antihypertensive medication(s) is permitted prior to study entry. Blood pressure must be re-assessed on 2 occasions separated by at least 1 hour. The mean SBP/DBP values must be < 150/90 for a subject to be eligible.
- •l. Ongoing treatment with therapeutic doses of warfarin (oral low-dose warfarin up to 2 mg daily for DVT prophylaxis is allowed)
- •m. Evidence of active bleeding or a bleeding diathesis at Screening
- •8. Significant gastrointestinal abnormalities:
- •a. Any history of major resection of the stomach or small bowel
- •b. Malabsorption syndrome with active symptoms within 3 months prior to Randomization
- •c. Active peptic ulcer within 3 months prior to Randomization
- •d. Intra-luminal bleeding lesions within 3 months prior to Randomization
- •e. History of abdominal fistula or intra-abdominal abscess within 3 months prior to Randomization
- •9. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- •10. Active autoimmune disease or condition requiring chronic immunosuppressive therapy
- •- NOTE: Abnormal laboratory values for autoimmunity markers in the absence of other signs/symptoms of autoimmune disease are not exclusionary.
- •11. Clinically significant infections, including human immunodeficiency virus (HIV),
研究者
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