EUCTR2014-004510-28-CZ进行中（未招募）1 期
An open-label, randomized, controlled, multicenter, phase II study evaluating safety and efficacy of intratumorally administered Intuvax pre-nephrectomy followed by Sunitinib post-nephrectomy, compared to Sunitinib post-nephrectomy in metastatic renal cell carcinoma patients
Immunicum Aktiebolag0 个研究点目标入组 90 人开始时间: 2015年9月14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
- 90
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
入选标准
- •1) Newly (<6 months) diagnosed RCC (histological/cytological verification is optional) with at least one (1) CT-verified metastasis =10 mm for which complete metastasectomy is not planned. US patients must have verified clear-cell tumor histology
- •2) Planned resection of primary tumor
- •3) Primary tumor diameter =40 mm
- •4) Candidate for first-line therapy with sunitinib initiated five (5) to eight (8) weeks after nephrectomy
- •5) Female or male =18 years of age
- •6) Willing and able to provide informed consent
- •7) Adequate hematological parameters, i.e.:
- •B-Leukocyte count =4.5 x109/L
- •B-Platelet count =150 x109/L
- •B-Hemoglobin (Hb) =90 g/L
- •8) Serum-creatinine and serum-bilirubin =1.5 × ULN. Serum-ALAT and serum-ASAT =2.5 × ULN (or =5 in case of liver metastases)
- •9) Female who has been post-menopausal for more than one (1) year or female of childbearing potential agreeing to use a highly efficient method of contraception (i.e. a method with less than 1% failure rate [e.g. sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner or combined birth control pills]) from Screening until 90 days after last dose of Intuvax and/or until completed sunitinib treatment whichever occurs later. Female of childbearing potential must have a negative blood pregnancy test at Screening, and if randomized to vaccination a negative blood or urine pregnancy test within one (1) day before each dose of Intuvax) and must not be lactating
- •Male agreeing to use condoms from Screening until 90 days after last dose of Intuvax and/or until completed sunitinib treatment whichever occurs later, or male having a female partner who is using a highly efficient method of contraception as described above
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1) Life expectancy less than 4 months
- •2) Central nervous system (CNS) metastasis that is symptomatic or progressing or untreated or that requires current therapy (e.g. evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases)
- •3) Active autoimmune disease which requires treatment with systemic immunosuppressive agents, e.g. inflammatory bowel disease, multiple sclerosis, sarcoidosis, psoriasis, autoimmune hemolytic anemia, rheumatoid arthritis, SLE, vasculitis, Sjögren's syndrome, scleroderma, autoimmune hepatitis, and other rheumatological diseases
- •4) Treatment with per oral systemic corticosteroids exceeding 10 mg/day within 7 days before Screening until Nephrectomy (inhaled, intranasal, and local steroids acceptable irrespective of dose)
- •5) Known cardiomyopathy and/or clinically significant abnormal ECG findings at Screening disqualifying the patient from nephrectomy and subsequent sunitinib treatment
- •6) Karnofsky performance status <70%
- •For patients in France Karnofsky performance status =70%
- •7) National Cancer Institute (NCI) Common Terminology criteria for Adverse Events (CTCAE) Grade 3 hemorrhage within 28 days before Screening
- •8) Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- •9) Clinically significant gastrointestinal abnormalities
- •10) Uncontrolled hypertension, or uncontrolled diabetes mellitus
- •11) Pulmonary embolism within 12 months prior to Screening
- •12) Prior history of invasive cancer within 5 years before Screening, except for adequately treated in situ carcinomas or non-melanoma skin cancer
- •13) Ongoing infection that requires parenteral treatment with antibiotics
- •14) Active or latent virus disease (HIV, HBV and HCV)
- •15) ECOG performance status >2 after optimization of analgesics
- •16) Abnormal or clinically significant coagulation parameters at the discretion of the investigator, i.e.:
- •Prothrombin Time - International Normalized Ratio (PT-INR)
- •Activated Partial Thromboplastin Time (APTT)
- •Patients being treated with anticoagulants are excluded if the coagulation parameters are outside the therapeutic intervals as described in the SmPC/USPI for the administered treatment
- •17) Known major adverse reaction/event in connection with previously made vaccination (e.g. asthma, anaphylaxis or other serious reaction)
- •18) Known hypersensitivity or allergy to sunitinib or to chemically related products or likely to be exacerbated by any component of the study products
- •19) Prior systemic antitumor therapy within 28 days before Screening Visit. However, local radiation therapy to any area except for the abdominal/retroperitoneal area including the kidney tumor is allowed
- •20) Exposure to other investigational products within 28 days prior to Screening Visit
- •21) Patients on anticoagulants for whom temporarily stop and start, supported by low molecular weight heparin (or other anticoagulation therapy at the discretion of the Investigator and/or per local standard of care) during vaccination and nephrectomy, is not an option
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