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

Phase 1

Completed

• Conditions: Bladder Cancer
• Interventions: Biological: MAGE-A3 ASCI; Biological: BCG

• Registration Number: NCT01498172
• Lead Sponsor: Patrice Jichlinski

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-06
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-23
• Study Start: 2012-01
• Status Verified: 2015-02
• Primary Completion: 2015-02
• Last Update Submitted: 2015-02-03
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NMIBC at high risk of progression	BCG	-
NMIBC at low risk of progression	MAGE-A3 ASCI	-
NMIBC at intermediate risk of progression	MAGE-A3 ASCI	-
NMIBC at intermediate risk of progression	BCG	-
NMIBC at high risk of progression	MAGE-A3 ASCI	-

Primary Outcome Measures

Name	Time	Method
Recording adverse events by assessment of vital signs, physical examination, haematology and blood chemistry to measure safety and tolerability	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois (CHUV); 🇨🇭 Lausanne, Switzerland