Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT02010203
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed non-muscle invasive bladder cancer \[Ta, T1 or Tis (CIS)\] that has been removed by transurethral resection
* Either: (i) high-risk disease, defined as T1 and/or high-grade and/or CIS or (ii) intermediate-risk disease, defined as Ta low-grade with at least 3 of the following 4 risk factors: multiple tumors, tumor size \> 3cm, early recurrence (\<1 year from previous staging procedure), or recurrence with a frequency of more than once in any 12 month period
* Not have received bacillus Calmette-Guérin (BCG) or have completed previous BCG treatment \> 12 months prior to the baseline staging procedure.
* Phase 2 Arms 1-3: Suitable to receive a 6-week course of BCG in the adjuvant setting within 6 weeks following TURBT. Phase 2 Arm 4: Suitable for monotherapy vaccine administration post-TURBT. For Phase 1 only: Has previously received 3-6 weekly doses of BCG.
* Adequate laboratory parameters
Exclusion Criteria:
* Human immunodeficiency virus (HIV) infection or immunodeficiency disorders, either primary or acquired
* Infections or intercurrent illness requiring active therapy
* Any condition requiring active steroid or other immunosuppressive therapy
* Active malignancies within the past 12 months except negligible risk of metastasis or death treated with expected curative outcome.
* Prostate pelvic radiation within the past 12 months
* Significant cardiac impairment
* Current alcohol or chemical abuse, or mental or psychiatric condition precluding protocol compliance
* Pregnant or nursing
* Allergy to soy, egg, or peanut products
* Receiving another investigational agent (30 day wash-out required prior to first dose)
* Neo-adjuvant therapy prior to baseline staging procedures for the current occurrence of non-muscle invasive bladder cancer
* Prior treatment with a cancer vaccine for this indication
* Prior vaccination with BCG for tuberculosis disease
* Prior splenectomy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02010203
Study Brief:
Protocol Section:
NCT02010203