Trial · NCT07189793
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response (CR) Rate at Month 3 in the CIS Cohort | Baseline to Month 3 | Proportion of participants in the CIS cohort achieving CR at month 3. CR is met by any of the following protocol-specified scenarios indicating no high-grade bladder disease: (a) negative urine cytology and negative cystoscopy; (b) negative cytology with cystoscopic lesions that are benign or low-grade Ta on biopsy; or (c) negative cystoscopy with positive cytology attributed to tumour in the upper tract or prostatic urethra and random bladder biopsies negative. |
| Primary | Median Recurrence-Free Survival (RFS) in the Non-CIS Cohort | From randomisation/start of treatment to first event, assessed up to 24 months | RFS is time to high-grade Ta recurrence, any T1, or new CIS, whichever occurs first. Recurrence requires cystoscopic suspicion confirmed by histopathology; if cytology becomes positive before histologic confirmation, the recurrence date is set at the first positive cytology once recurrence is subsequently confirmed. Death from any cause before documented recurrence is counted as an event. |
| Secondary | CR Rates at Months 6, 12, 18, and 24 in the CIS Cohort | Baseline to months 6, 12, 18, and 24 | Proportion of participants in the CIS cohort with CR at the specified time points using the protocol CR definition. |
| Secondary | Progression-Free Survival (PFS) Rates at Months 6, 12, 18, and 24 in the CIS Cohort | Baseline to months 6, 12, 18, and 24 | Proportion without progression at each time point. Progression is defined as lamina propria invasion from Ta/CIS to T1, or progression to ≥T2, or new nodal or distant metastasis. |
| Secondary | Overall Survival at Month 24, EOT+6 Months, and EOT+12 Months in the CIS Cohort | Baseline to Month 24, EOT+6 months, and EOT+12 months | Survival status at prespecified landmarks. |
| Secondary | Incidence of Adverse Events in the CIS Cohort | From first dose/instillation to 90 days post-last dose/instillation (≈ up to 27 months) | Participants with treatment-emergent AEs and grade ≥3 AEs (MedDRA; CTCAE v5.0). Immune-related and instillation-related events summarised. |
| Secondary | Recurrence-Free Survival Rates at Months 6, 12, 18, and 24 in the Non-CIS Cohort | Baseline to months 6, 12, 18, and 24 | Proportion without recurrence (high-grade Ta, any T1, or new CIS) or death at each time point; recurrence confirmation rules per protocol. |
| Secondary | High-Grade Recurrence-Free Survival (HG-RFS) Rates at Months 6, 12, 18, and 24 in the Non-CIS Cohort | Baseline to months 6, 12, 18, and 24 | Proportion without high-grade recurrence at each time point. High-grade recurrence is defined as Tis or Ta/T1 high-grade, or muscle-invasive disease identified at TURBT or cystectomy. |
| Secondary | Progression-Free Survival Rates at Months 6, 12, 18, and 24 in the Non-CIS Cohort | Baseline to Months 6, 12, 18, and 24 | Proportion without progression (lamina propria invasion from Ta/CIS to T1, progression to ≥T2, or new nodal/distant metastasis). Death before documented progression counts as an event. |
| Secondary | Overall Survival at Month 24, EOT+6 Months, and EOT+12 Months in the Non-CIS Cohort | Baseline to Month 24, EOT+6 months, and EOT+12 months | Survival status at prespecified landmarks. |
| Secondary | Incidence of Adverse Events in the Non-CIS Cohort | From first dose/instillation to 90 days post-last dose/instillation (≈ up to 27 months) | Participants with treatment-emergent AEs and grade ≥3 AEs (MedDRA; CTCAE v5.0). |
| Other | CR Rate at Month 3 in PD-L1-Positive Participants in the CIS Cohort | Baseline to Month 3 | Proportion of PD-L1-positive participants in the CIS cohort who achieve CR at Month 3. CR is met by any of: (a) negative urine cytology and negative cystoscopy; (b) negative cytology with cystoscopic lesions that are benign or low-grade Ta on biopsy; or (c) negative cystoscopy with positive cytology attributed to tumour in the upper tract or prostatic urethra and random bladder biopsies negative. |
| Other | CR Rate at Month 3 in PD-L1-Negative Participants in the CIS Cohort | Baseline to Month 3 | Proportion of PD-L1-negative participants in the CIS cohort who achieve CR at Month 3; CR definition as above. |
| Other | Median Recurrence-Free Survival in PD-L1-Positive Participants in the Non-CIS Cohort | From randomisation/start of treatment to first event, up to 24 months | RFS is time from randomisation/start of treatment to high-grade Ta recurrence, any T1, or new CIS, whichever occurs first. Recurrence requires cystoscopic suspicion confirmed by histopathology; if cytology becomes positive before histologic confirmation, the event date is the first positive cytology once recurrence is subsequently confirmed. Death before recurrence counts as an event. |
| Other | Median Recurrence-Free Survival in PD-L1-Negative Participants in the Non-CIS Cohort | From randomisation/start of treatment to first event, up to 24 months | RFS definition and event-dating rules as above. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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