E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
BLADDER CANCER AFTER TRANSURETRHAL RESECTION |
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MedDRA Classification |
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 |
Phase II: To demonstrate a superior safety profile of Bexidem with respect to “Frequent Immunotherapy-Linked Adverse Events” (FILAEs) compared to BCG therapy. Phase III: To compare efficacy (recurrence-free survival) of Bexidem therapy to BCG therapy. |
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E.2.2 | Secondary objectives of the trial |
Phase II: To evaluate overall efficacy and recurrence-free survival in patients treated with BEXIDEM therapy.Phase III: To evaluate overall safety of BEXIDEM therapy as compared to BCG. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
·Male and female patients Over 18 years of age Fully resected papillary transitional cell carcinoma Stage TaGI, TaGII, TaGIII, T1GI or T1GII (N0, M0) Either of the following: Plurifocal tumors or, Unifocal tumor with ≥ 2 tumor occurences within the last 24 months WHO performance state 0-2 Normal upper urinary tract as documented by either IV urography or CT-scan Blood creatinine < 200 µmol/L, ALT and AST < 2,5 x ULN, Leukocytes ≥ 3,500/mm3 Able to understand and follow treatment scheme Signed and dated Informed Consent |
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E.4 | Principal exclusion criteria |
·≥ T1 GIII bladder cancer Carcinoma in situ (CIS) Active tuberculosis/Other active infection (including urinary tract infection) and/or infections that may compromise the immune system such as HIV, HTLV, Hepatitis B or Hepatitis C infection/History of other active malignancy within five years, except adequately treated basal cell and squamous cell carcinoma of the skin /Other serious illness or medical conditions (e.g. history of significant cardiac or respiratory dysfunction) Patients with a contra-indication preventing apheresis / History of autoimmune-related disorder / Known hypersensitivity to any of the components of the study drugs (e.g. DMSO) Immunosuppression or congenital or acquired immune deficiencies, whether due to concurrent disease (e.g. AIDS, leukaemia, lymphoma), cancer therapy (cytotoxic drugs, radiotherapy) or immunosuppressive therapy (e.g. corticosteroids, cyclosporinFamily history of Creutzfeldt-Jacob disease and/or Risk of Creutzfeldt-Jacob disease defined as patient having received extracted growth hormone or neurosurgery before 1996 Prior systemic reaction to BCG therapy Pregnant or nursing women |
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E.5 End points |
E.5.1 | Primary end point(s) |
The two-point objectives of this trial are (i) to demonstrate a superior safety profile of BEXIDEM-therapy compared to BCG as assessed by “Frequent Immunotherapy-Linked Adverse Events” (FILAEs), and (ii) to compare the efficacy of BEXIDEM therapy to BCG-therapy as assessed by recurrence-free survival.It is intended to conduct an analysis at the end of Phase II for the Phase II primary endpoint (safety profile) and an interim analysis to determine the number of additional patients required to complete a Phase III step to compare the efficacy of BEXIDEM therapy to BCG. A decision whether to continue or to discontinue the trial will be taken at the interim point. |
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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 | Information not present in EudraCT |
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) | Yes |
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 | No |
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 | No |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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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PHASE III: DEPENDENT UPON TOTAL NUMBER OF PATIENTS |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 6 |