Clinical trial · Observational
Follow up of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC)
QUILT-205: Long-Term Follow-Up of Subjects in QUILT-2.005 Phase 1b Trial of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC)
NCT05981131CI-TRIAL-00109787active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this clinical trial is to obtain long-term follow-up information and status of bladder cancer for patients who received study treatment in the QUILT-2.005 study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| N803 plus Bacillus Calmette-Guerin (BCG) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Obtain Long Term Follow-Up data to be summarized using descriptive statistics
- timeFrame
- assessed up to 60 months
- description
- Follow-up data on survival status, bladder cancer status (high-grade or low-grade), cystoscopy results (including number of cystoscopies done for each subject), biopsy results, upper tract evaluations, posttherapies and responses and outcomes of posttherapies, urine cytology results, and other medical history or treatments (if available) related to bladder cancer will be collected from subjects who were enrolled and treated in QUILT-2.005 phase 1b study with intravesical N-803 plus BCG. Study endpoints will be summarized with descriptive statistics. Continuous variables will be summarized as mean, median, standard deviation, and minimum and maximum values. Categorical variables will be summarized as the number and percentage of subjects in each category. All confidence intervals will be constructed at the two-sided 95% level of confidence.
- measure
- Assess the Complete response yearly
- timeFrame
- assessed up to 60 months
- description
- CR rate yearly following completion of QUILT-2.005 phase 1b for subjects with CIS disease with or without papillary disease at the initial diagnosis. CR rate (as determined by the Investigator) yearly following completion of QUILT-2.005 phase 1b will be reported along with a two-sided exact 95% confidence interval. The exact confidence interval will be calculated using the Clopper-Pearson method.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Enrolled and treated with intravesical N-803 plus BCG in the phase 1b portion of QUILT-2.005. Exclusion Criteria: * Not applicable
References
Publications (0)
Data not yet available
No reference posted for this study.