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

Patrice Jichlinski

Status and phase: Completed; Phase 1

Conditions: Bladder Cancer

Treatments: Biological: BCG; Biological: MAGE-A3 ASCI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01498172

URO-68/11

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 3 patient groups

NMIBC at intermediate risk of progression

Experimental group

Treatment:

Biological: MAGE-A3 ASCI

Biological: BCG

NMIBC at high risk of progression

Experimental group

Treatment:

Biological: MAGE-A3 ASCI

Biological: BCG

NMIBC at low risk of progression

Experimental group

Treatment:

Biological: MAGE-A3 ASCI