BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Non Muscle Invasive Bladder Cancer (NMIBC) Patients

Study Overview
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Brief Summary
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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.

Official Title
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BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Patients With Non Muscle Invasive Bladder Cancer

Conditions
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Bladder Cancer

Intervention / Treatment
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* Biological: MAGE-A3 ASCI
* Biological: BCG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patient with histological confirmation of NMIBC Full recovery from surgery (TUR) from 1 to 6 weeks Karnofsky performance status of 60% or more Laboratory parameters for vital functions should be in the normal range Women of childbearing potential must use adequate contraception and have negative pregnancy test before and during the whole period of study treatment administration Male patients should avoid behaviors leading to child conception up to 2 months after administration of study treatment Exclusion Criteria: Muscle invasive bladder cancer Metastatic disease to the central nervous system, for which other therapeutic options, including radiotherapy, may be available Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders) Any confirmed or suspected immunosuppressive or immunodeficient condition or potential immune-mediated diseases(Patients with vitiligo are not excluded to participate in the trial) History of severe allergic reactions to vaccines or unknown allergens Patients require concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents. The use of prednisone, or equivalent, <0.125 mg/kg/day (absolute maximum 10 mg/day), or inhaled corticosteroids or topical steroids is permitted Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study agent Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study Lack of availability for immunological and clinical follow-up assessment For female patients of childbearing potential: positive urine or serum pregnancy test or lactating Known positive HIV test, HBV, HCV.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NMIBC at intermediate risk of progression<br> | Biological: MAGE-A3 ASCI<br>* 5 doses every 3 weeks<br>Biological: BCG<br>* 1 intravesical dose /week for 6 weeks<br>* Other names: Oncotice;|
| Experimental: NMIBC at high risk of progression<br> | Biological: MAGE-A3 ASCI<br>* 5 doses every 3 weeks<br>Biological: BCG<br>* 1 intravesical dose /week for 6 weeks<br>* Other names: Oncotice;|
| Experimental: NMIBC at low risk of progression<br> | Biological: MAGE-A3 ASCI<br>* 5 doses every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Assessment of disease recurrence by control cystoscopy |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non muscle invasive bladder cancer