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

• Conditions: Metastatic renal cell carcinoma; MedDRA version: 9.1Level: LLTClassification code 10050513Term: Metastatic renal cell carcinoma

• Registration Number: EUCTR2007-002556-41-CZ
• Lead Sponsor: Trimed Biotech GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

•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

Exclusion Criteria

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified