E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic renal cell carcinoma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050513 |
E.1.2 | Term | Metastatic renal cell carcinoma |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate efficacy and safety of Trivax in patients with metastatic renal cell carcinoma who are treated with Sunitinib. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Tumour progression scale according to the RECIST criteria.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Standard therapy with Sunitinib |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 19 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |