Metastatic renal cell carcinoma MedDRA version: 9.1 Level: LLT Classification code 10050513 Term: Metastatic renal cell carcinoma
Conditions
Sponsors
Trimed Biotech GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 180 mm Hg and/or diastolic >100 mm Hg). •Sero-positivity for HIV1, 2, Treponema pallidium and active Hepatitis B and C infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy and safety of Trivax in patients with metastatic renal cell carcinoma who are treated with Sunitinib.;Secondary Objective: ECOG (Eastern Cooperative Oncology Group) performance status, DTH-skin test for in vivo assessment of antitumour immunity. Immunological in vitro assay to determine anti-tumour immunity.;Primary end point(s): Tumour progression scale according to the RECIST criteria. | — |
Countries
Czech Republic
Outcome results
None listed