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

Phase 1
18 Years
Open (Enrolling by invite only)
Bladder Cancer

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Patrice Jichlinski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Lausanne (CHUV)


Switzerland: Swissmedic

Study ID:




Start Date:

January 2012

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Non muscle invasive bladder cancer
  • Urinary Bladder Neoplasms