NCT01498172

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 23, 2011

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

3.1 years

First QC Date

December 6, 2011

Last Update Submit

February 3, 2015

Conditions

Bladder Cancer

Keywords

Non muscle invasive bladder cancer

Outcome Measures

Primary Outcomes (1)

  • Recording adverse events by assessment of vital signs, physical examination, haematology and blood chemistry to measure safety and tolerability

    6 months

Secondary Outcomes (3)

  • 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

Study Arms (3)

NMIBC at intermediate risk of progression

EXPERIMENTAL
Biological: MAGE-A3 ASCIBiological: BCG

NMIBC at high risk of progression

EXPERIMENTAL
Biological: MAGE-A3 ASCIBiological: BCG

NMIBC at low risk of progression

EXPERIMENTAL
Biological: MAGE-A3 ASCI

Interventions

MAGE-A3 ASCIBIOLOGICAL

5 doses every 3 weeks

NMIBC at high risk of progressionNMIBC at intermediate risk of progressionNMIBC at low risk of progression
BCGBIOLOGICAL

1 intravesical dose /week for 6 weeks

Also known as: Oncotice
NMIBC at high risk of progressionNMIBC at intermediate risk of progression

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsNon-Muscle Invasive Bladder Neoplasms

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Tuberculosis VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Patrice Jichlinski, MD

    University Hospital Lausanne (CHUV)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of Urology Department

Study Record Dates

First Submitted

December 6, 2011

First Posted

December 23, 2011

Study Start

January 1, 2012

Primary Completion

February 1, 2015

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations

CH(1)