EUCTR2012-000871-17-HU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
适应症
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 predominatly clear cell histology
- •3. Metastatic disease (measureable or non-measurable) that can be monitored throughout the course of the study participation per RECIST 1.1
- •4. Subjects who are candidates for standard first-line therapy initiating with sunitinib
- •5. Time from initial RCC diagnosis to initiation of systemic treatment (sunitinib) <1 year
- •6. Karnofsky Performance Status (KPS) = 70%
- •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 central laboratory values for all three of the following criteria:
- •a. Absolute neutrophil count (ANC) = LLN, and
- •b. Platelets = 75,000/mm3 or 75.0 x 109/L, and
- •c. Hemoglobin (Hgb) = 9.0 g/dL
- •10. Adequate renal function, as defined by either of the following criteria:
- •a. Serum creatinine = 1.5 x upper limit of normal (ULN)
- •b. OR, if serum creatinine > 1.5 x ULN, estimated glomerular filtration rate (eGFR) = 30 mL/min
- •11. Adequate hepatic function, as defined by both of the following:
- •a. Total serum bilirubin = 1.5 x ULN
- •b. 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
- •12. Adequate coagulation function as defined by either of the following criteria:
- •a. INR <1.5 x ULN
- •b. For subjects receiving warfarin or LMWH, the subjets must, in the investigator's opinion, be clinically stable with no evidence of active bleeding while receiveing anticoagulant therapy. The INR for these patietns may exceed 1.5 x ULN if that is the goal of anticoagulant therapy.
- •13. 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
- •14. Normal ECG or clinically non-significant finding(s) at Screening, in the Investigator's opinion
- •15. Able to abstain from taking prohibited drugs, either prescription or non-prescription, during the treatment phase of the study
- •16. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- •17. 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 within the preceding 3 years, except for adequately treated in situ carcinomas or non-melanoma skin cancer, adequately treated early stage breast cancer, superficial bladder, and non-metastatic prostate cancer with a normal PSA.
- •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. Hgb < LLN
- •b. Corrected calcium > 10.0 mg/dL
- •c. KPS < 80%
- •d. Neutrophils > ULN
- •e. Platelets > ULN
- •5. NCI CTCAE Grade 3 hemorrhage < 28 days before Visit 1 (Day 0)
- •6.Clinically significant cardiovascular conditions within 3 months prior to Randomization which in the Investigator's opinion prohibits the initiation of standard targeted therapy, initiating with sunitinib, 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), per NYHA Classification
- •f. Symptomatic peripheral vascular disease
- •g. Cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- •h. Pulmonary Sumptomatic or uncontrolled pulmonary embolism or deep vein thrombosis (DVT)
- •i. Uncontrolled 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. Uncontrolled or untreated atrial fibrillation
- •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 mm Hg for a subject to be eligible.
- •l. Evidence of active bleeding or a bleeding diathesis at Screening
- •7. Significant gastrointestinal abnormalities:
- •a. Any history of major resection of the stomach or small bowel with ongoing impaired healing, which would significantly impair the absorption of sunitinib or other permitted oral targeted therapies during study treatment, in the Investigator's opinion
- •b. Malabsorption syndrome with active symptoms which would significantly impair the aborption of sunitinib or other permitted oral targeted therapies in the Investigator's opinion, within 3 months prior to Randomization
- •c. Active peptic ulcer which cannot be appropriately managed in the Investigator's opinion,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
- •8. Pre-existing thyroid abnormality with thyroid function that cannot be appropriately managed with medication, in the Investigator's opinion
- •9. Active autoimmune disease or condition requiring chronic immunosuppressive therapy such as rheumatic arthritis, systemic lupus erythematous, multiple scleorsis, organ transplant recipient, etc.)
- •- NOTE: Abnormal laboratory values for autoimmunity markers in the absence of other signs/symptoms of autoimmune disease are not exclusionary.
研究者
相似试验
进行中（未招募）
1 期
Personalized immune therapy (AGS-003) plus standard treatment for advanced kidney cancerEUCTR2012-000871-17-ESArgos Therapeutics, Inc.450
进行中（未招募）
不适用
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less.Patients with confirmed diagnosis of node positive (1-3 nodes)invasive breast carcinoma with positive hormone receptor status, and negative HER-2.MedDRA version: 14.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-000174-37-ESGEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)3,500
进行中（未招募）
1 期
Phase III Randomized Controlled Trial of Pembrolizumab with or without Chemo vs Chemo in Advanced Urothelial CarcinomaAdvanced or Metastatic Urothelial CarcinomaMedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 100000004864EUCTR2015-005731-41-IEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.990
已完成
3 期
A Phase III Randomized, Controlled Clinical Trial of Pembrolizumab with or without Platinum-Based Combination Chemotherapy versus Chemotherapy in Subjects with Advanced or Metastatic Urothelial Carcinomabladder cancerNL-OMON45288Merck Sharp & Dohme (MSD)20
进行中（未招募）
1 期
Phase III Randomized Controlled Trial of Pembrolizumab with or without Chemo vs Chemo in Advanced Urothelial CarcinomaAdvanced or Metastatic Urothelial CarcinomaMedDRA version: 19.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 100000004864EUCTR2015-005731-41-ESMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.990