Trial · NCT05024773
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Centrally assessed Complete Response Rate (CRR) at any time. | CRR will be evaluated at any time from enrollment to 24 months after induction or re-induction start. | CRR calculated as the proportion of patients achieving a CR at any time within 24 months after induction or re-induction start. CRR will be based on central assessment of response |
| Secondary | Centrally assessed CRR | CRR will be evaluated at 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48 months after induction or re-induction | CRR calculated as the proportion of patients achieving a CR at 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48 months after induction or re-induction start |
| Secondary | Duration of Response (DoR) | DoR will be evaluated at 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48 months after induction or re-inductiononths after treatment start | DoR defined as the time from first documented evidence of CR to time of documented recurrence (CIS or Ta-T1), progression to MIBC, to extravesical disease, or death |
| Secondary | Duration of Response (DoR) rate | DoR rates will be evaluated at 6, 9, 12, 15, 18, 21, 30, 36, 42 and 48 after induction or re-induction start | DoR rate calculated as the proportion of patients who maintained a CR after 6, 9, 12, 15, 18, 21, 30, 36, 42 and 48 months after induction or re-induction start. |
| Secondary | Progression rate | Progression rate will be evaluated at EOIT/EROIT, 15, 24 and 48 months after induction or re-inductionstart | Progression rate calculated as the proportion of patients with muscle invasion or extravesical expansion of the disease at EOIT/EORIT, 15, 24 and 48 months after induction or re-induction start |
| Secondary | Time to progression | Time to progression will be evaluated at 15, 24 and 48 months after induction or re-induction start | Time to progression defined as time from treatment start to time of documented tumor progression to MIBC or extravesical disease. |
| Secondary | Rate of patients undergoing cystectomy | Rate of patients undergoing cystectomy will be evaluated at EOIT/EROIT, 9, 15, 24, 24 and 48 months after induction or re-induction start. | Proportion of patients undergoing cystectomy for disease progression at EOIT/EORIT, 9, 15, 24 and 48 months after induction or re-induction start. |
| Secondary | Time to cystectomy defined as time from start of treatment to the date of cystectomy | from start of treatment to date of cystectomy | Time to cystectomy is defined as the time (months) form start of treatment to the date of cystectomy, analyzed using the Kaplan-Meier method. The median time to cystectomy will be presented along with 95% CI. |
| Secondary | event-free survival (EFS) | Event-free survival (EFS) will be evaluated at any time during the study up to 48 months after treatment start | EFS defined as time from treatment start to the time of documented recurrence after CR, or progression or death due to any cause. |
| Secondary | Overall survival (OS) | overall survival (OS) will be evaluated at any time during the study up to 48 months after treatment start | OS defined as time from treatment start to death due to any cause. |
| Secondary | Incidence of Treatment-Emergent Adverse Events (Overall Safety) | Safety data will be evaluated up to study month 16 | Overall safety and tolerability evaluated throughout the study on the basis of the incidence, nature, severity and causality of TEAEs, coded to preferred term and system organ class (SOC) using the Medical Dictionary for Regulatory Activities (MedDRA) and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5 and the incidence of serious adverse events (SAEs) |
| Secondary | Treatment time of retention (tolerability) | Tolerability will be evaluated up to study month 16 | The tolerability of ONCOFID-P-B expressed as the ability to retain intravesical instillation for the desired dwell time (optimal retention time is 120 minutes) and measured as time of retention. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05024773/registered