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| Name | Class |
|---|---|
| Ludwig Center for Cancer Research of Lausanne | OTHER |
| GlaxoSmithKline | INDUSTRY |
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In this study, the investigators would like to assess how intravesical BCG schedules after immunization of non muscle invasive bladder patients with the recMAGE-A3 protein, together with adjuvant AS15 (recMAGE-A3 + AS15 ASCI), may enhance innate and vaccine-specific T cell responses both systemically and locally in the bladder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMIBC at intermediate risk of progression | Experimental |
| |
| NMIBC at high risk of progression | Experimental |
| |
| NMIBC at low risk of progression | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAGE-A3 ASCI | Biological | 5 doses every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recording adverse events by assessment of vital signs, physical examination, haematology and blood chemistry to measure safety and tolerability | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Flow cytometric analysis of type and number of immune cell types in urine | 6 months | |
| Measurement of titers of antibodies against recMAGE-A3 in serum | 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
The use of prednisone, or equivalent, <0.125 mg/kg/day (absolute maximum 10 mg/day), or inhaled corticosteroids or topical steroids is permitted
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| Name | Affiliation | Role |
|---|---|---|
| Patrice Jichlinski, MD | University Hospital Lausanne (CHUV) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | 1011 | Switzerland |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 11, 2016 | |
| Reset | Dec 5, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 11, 2016 | Dec 5, 2016 |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001500 | BCG Vaccine |
| ID | Term |
|---|---|
| D032581 | Tuberculosis Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| BCG | Biological | 1 intravesical dose /week for 6 weeks |
|
|
| Assessment of disease recurrence by control cystoscopy |
| 6 months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D045424 |
| Complex Mixtures |