Clinical trial · Interventional
BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Non Muscle Invasive Bladder Cancer (NMIBC) Patients
BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Patients With Non Muscle Invasive Bladder Cancer
NCT01498172CI-TRIAL-00016774completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCG | Biological | — | UNRESOLVED |
| MAGE-A3 ASCI | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- NMIBC at intermediate risk of progression
- interventionNames
- Biological: MAGE-A3 ASCI
- Biological: BCG
- type
- EXPERIMENTAL
- label
- NMIBC at high risk of progression
- interventionNames
- Biological: MAGE-A3 ASCI
- Biological: BCG
- type
- EXPERIMENTAL
- label
- NMIBC at low risk of progression
- interventionNames
- Biological: MAGE-A3 ASCI
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.