A randomized, open-label, 2-arm, multicentre, Phase II study to evaluate the safety and efficacy of Trivax, a dendritic cell-based interleukin-12 secreting autologous cancer vaccine, in combination with Sunitinib compared with Sunitinib alone as first line treatment for patients with metastatic renal-cell carcinoma (mRCC). - Decavarec Study TRX 1.0

Trimed Biotech GmbH0 个研究点目标入组 70 人开始时间: 2008年1月8日最近更新: 2013年1月7日

适应症

试验速览

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•18 to 80 years of age, inclusive, on the day of screening.
•Able to comply with the protocol and provide written informed consent prior to any study specific screening activities entry.
•ECOG performance status = 1.
•Patients with histologically or cytologically confirmed clear cell mRCC with at least one measurable lesion or non-measureable lesion at baseline.
•Nephrectomy or nephron-sparing surgery has to be carried out prior to IMP administration.
•Patients must be eligible for Sunitinib treatment.
•Patients who were treated with systemic immune suppressive therapy are only eligible if they received their last immune therapy = 4 weeks prior to randomization.
•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

•Pregnant or lactating females. Pregnancy test to be assessed within 7 days prior to study treatment start.
•Evidence of an active infectious disease or active autoimmune disease.
•Evidence of other primary tumours (including primary brain tumour) within the last 5 years prior to randomization except for adequately treated carcinoma in situ of the cervix, squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
•Renal insufficiency requiring haemodialysis.
•Impaired renal function (serum creatinine >2.0 times upper limit of normal (ULN).
•Impaired hepatic function (SGOT and SGPT >2.5 times ULN).
•Impaired bone marrow function, including WBC <1 x 109/L, Hb <7,5 g/dL, or platelet count < 100 x 109/L.
•History of significant cardiovascular disease (myocardial infarct <3 months, unstable angina pectoris, NYHA (New York Heart Association) class II-IV, serious cardiac arrhythmia requiring medication).
•Untreated hypertension (systolic >180 mm Hg and/or diastolic >100 mm Hg).
•Sero-positivity for HIV1, 2, Treponema pallidium and active Hepatitis B and C infection.

发起方

Trimed Biotech GmbH