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

immatics biotechnologies GmbH0 个研究点目标入组 339 人开始时间: 2010年12月23日最近更新: 2021年12月21日

适应症

试验速览

暂无简介。

•1.Aged at least 18 years
•2.HLA type: HLA-A*02-positive
•3.Metastatic and/or locally advanced RCC with clear cell histology 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
•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
•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 250
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•1.Prior systemic therapy for metastatic disease.
•2.History of or current brain metastases.
•3.Abnormal = CTC Grade 3 laboratory values at screening 2 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
•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.
•11.Received study drug within any clinical study (including approved and experimental drugs) within 4 weeks before sunitinib start
•12.Serious intercurrent illness
•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

发起方