EUCTR2014-004510-28-LV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
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
- Immunicum AB
- 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
- •- Recent (<6 months) diagnosed RCC with at least one (1) CT-verified metastasis
- •- Planned resection of primary tumor
- •- Primary tumor diameter =4 cm
- •- Candidate for standard first-line therapy with Sunitinib
- •- Female or male =18 years of age
- •- Willing and able to provide informed consent
- •- Adequate hematological parameters, i.e:
- •B-Leukocyte count =4.5 x10^9/L
- •B-Platelet count =150 x10^9/L
- •B-Haemoglobin =100 g/L
- •- Adequate liver function, i.e. Child-Pugh maximum stage A
- •- Female who has been post-menopausal for more than one (1) year or female of childbearing potential using a highly efficient method of contraception (i.e. a method with less than 1% failure rate [e.g. sterilisation, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner or combined birth control pills]) during the study. 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 during the study, 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
- •- Life expectancy less than 4 months
- •- 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
- •- Treatment with systemic corticosteroids (inhaled, intranasal and local steroids accepted) within 7 days before Screening.
- •- Known cardiomyopathy and/or clinical significant finding in ECG at Screening
- •- Karnofsky performance status <70%, Section 3.2
- •- NCI CTCAE Grade 3 hemorrhage within 28 days before Screening
- •- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- •- Clinically significant gastrointestinal abnormalities
- •- Uncontrolled hypertension, or uncontrolled diabetes mellitus
- •- Pulmonary embolism within 12 months from randomization
- •- Prior history of invasive malignancy, except for adequately treated in situ carcinomas or non-melanoma skin cancer
- •- Ongoing infection that requires parenteral treatment with antibiotics
- •- Active or latent virus disease (HIV, HBV and HCV)
- •- ECOG performance status >2 after optimization of analgesics, Section 3.2
- •- Inadequate coagulation parameters, i.e:
- •* Prothrombin Time - International Normalized Ratio (PT-INR)
- •* Activated Partial Thromboplastin Time (APTT)
- •- Known major adverse reaction/event in connection with previously made vaccination (e.g. asthma, anaphylaxis or other serious reaction)
- •- Known hypersensitivity or allergy to Intuvax, to chemically related products
- •- Prior antitumor therapy within 28 days before Screening visit
- •- Exposure to other investigational products within 28 days prior to Screening
- •- History of alcohol or substance abuse
- •- Any reason that, in the opinion of the investigator, contraindicates that the patient participates in the study
研究者
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