EUCTR2010-022459-45-NL进行中（未招募）1 期
A randomized, controlled Phase III study investigating IMA901 multipeptide cancer vaccine in patients receiving sunitinib as first-line therapy for advanced/metastatic renal cell carcinoma - IMA901 in patients receiving sunitinib for advanced/metastatic RCC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 339
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.Aged at least 18 years
- •2.HLA type: HLA-A*02-positive (assessed by a central laboratory, the result of HLA-testing will be available within a maximum of 5 days)
- •3.Metastatic and/or locally advanced RCC with clear cell histology (histological confirmation by local pathologist required). NOTE: prior nephrectomy is NOT required.
- •4.Measurable and/or non-measurable tumor lesions as per RECIST 1.1 based on the local assessment.
- •5.Patients who are candidates for a first-line therapy with sunitinib
- •6.Favorable or intermediate risk according to the 6-score risk criteria in patients treated with VEGF-targeted agents according to Heng (Heng et al, 2009). Laboratory values for risk categorization will be determined by a central laboratory. The subject has a favorable risk if none, or intermediate risk if one or two of the following criteria apply (if three or more criteria apply the subject is not eligible):
- •a.Hemoglobin < LLN
- •b.Serum corrected calcium > ULN
- •c.Karnofsky performance status < 80%
- •d.Time from initial diagnosis to initiation of therapy < 1 year
- •e.Absolute neutrophil count > ULN
- •f.Platelets > ULN
- •7.Able to understand the nature of the study and give written informed consent
- •8.Willingness and ability to comply with the study protocol for the duration of the study
- •9.Female patients who are post menopausal (no menstrual period for a minimum of 1 year), or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or practice one of the following medically acceptable methods of birth control:
- •Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the patient’s usual menstrual cycle period) before study entry.
- •Intrauterine device (IUD).
- •Double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).
- •10.Male patients willing to use contraception (condoms with spermicidal jellies or cream) upon study entry and during the course of the study or have undergone vasectomy
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Prior systemic therapy for metastatic disease. (Note: prior adjuvant treatment for non-metastatic disease is allowed, however adjuvant therapy must have been stopped = 1 year before Visit C).
- •2.History of or current brain metastases.
- •3.Abnormal = CTC Grade 3 laboratory values at screening 2 (assessed by a central laboratory) for hematology (Hb, WBC, neutrophils, lymphocytes, platelets), liver (serum bilirubin, ALAT or ASAT) and renal function (serum creatinine).
- •4.Metastatic second malignancy
- •5.Localized second malignancy expected to influence the patient’s life span.
- •6.Patients with a history or evidence of systemic autoimmune disease, e.g. rheumatoid arthritis, multiple sclerosis, systemic lupus erythematodes (SLE), scleroderma, Sjögren's syndrome, Wegener's granulomatosis, Guillain-Barre syndrome
- •7.Known active hepatitis B or C infection
- •8.Known HIV infection
- •9.Active infections requiring oral or intravenous antibiotics
- •10.Any other known infection with a biological agent that can cause a severe disease and poses a severe danger to lab personnel working on patient tissues. Examples are: rabies, mycobacterium leprae, plasmodium falciparum, coccidiodes immitis.
- •11.Received study drug within any clinical study (including approved and experimental drugs) within 4 weeks before sunitinib start
- •12.Serious intercurrent illness, which according to the investigator, poses an undue risk for the patient when participating in the trial, including, but not limited to, any of the following:
- •Clinically significant cardiovascular disease (e.g., uncontrolled hypertension; clinically significant cardiac arrhythmia, clinically significant QT-prolongation),
- •New York Heart Association class III-IV congestive heart failure
- •Symptomatic peripheral vascular disease
- •Severe pulmonary dysfunction
- •Psychiatric illness or social situation that would preclude study compliance
- •13. Less than 12 months since any of the following:
- •Myocardial infarction
- •Severe or unstable angina
- •Coronary or peripheral artery bypass graft
- •Cerebrovascular event incl. transient ischemic attack
- •Pulmonary embolism / deep vein thrombosis (DVT)
- •14. Pregnancy or breastfeeding
- •15. Any condition which in the judgment of the investigator would place the patient at undue risk or interfere with the results of the study
研究者
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