Trial · NCT02138734
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response (CR) Rate | 6 Months | Patients in Cohort A: compare complete response rate between treatment arms using cystoscopy, confirmatory bladder biopsy and urine cytology. |
| Primary | Disease Free Survival (DFS) | 13 Years and 3 Months | Patients in Cohort B: compare disease-free survival between treatment arms using cystoscopy, confirmatory bladder biopsy and urine cytology. |
| Secondary | Progression-free survival (PFS) | 13 Years and 3 Months | For phase IIb, Cohorts A \& B: Time from randomization to disease progression or death. |
| Secondary | Overall survival | 13 Years and 3 months | Time from randomization to death resulting from any cause to determine survival. |
| Secondary | Disease specific survival | 13 Years and 3 months | For phase IIb, Cohorts A \& B: Time from randomization to death resulting from bladder cancer. |
| Secondary | Time to disease worsening | 13 Years and 3 Months | For phase IIb, Cohorts A \& B: Cystectomy or change in therapy indicative of more advanced disease, including systemic chemotherapy or radiation therapy. |
| Secondary | Cystectomy Free Rate | 13 years and 3 months | Cystectomy-free rate will be calculated for each treatment group as the ratio of the number of subjects who don't have documented cystectomy in the database divided by the number of subjects in the ITT (Intent to treat) population. |
| Secondary | Safety Profile: Number and severity of treatment emergent AEs [Time Frame: 39 Months] | 39 Months | For phase Ib and phase IIb: Number of participants with TEAEs as assessed by CTCAE v4.03. |
| Secondary | Duration of Complete Response | 13 Years and 3 months | To assess the duration of CR of patients treated with N-803 plus BCG compared to patients treated with BCG alone. |
| Secondary | Complete Response Rate( All Recurrent Bladder Cancer Including Low Grade Ta Disease) | 13 Years and 3 months | To assess the CR rate (all recurrent bladder cancer including low grade Ta disease) of patients treated with N-803 plus BCG compared to patients treated with BCG alone. |
| Secondary | Long Term Complete Response Rate | 13 years and 3 Months | To assess the long-term CR rate (as determined by the Investigator) following completion of QUILT-2.005 phase 2b. |
| Secondary | Duration of Complete Response ( All Recurrent Bladder Cancer Including Low Grade Ta Disease) | 13 Years and 3 months | Time from the date of first CR (All Recurrent bladder cancer including low grade Ta Disease) to the date of evidence that the subject no longer meets the definition for CR. |
| Secondary | Cohort B: Disease Free Survival Rate | 36 Months | To assess DFS rate at 12, 18, 24, 30, and 36 months. The time from randomization until recurrence of high-grade Ta (excluding low grade Ta) or any grade T1, CIS, disease progression, cystectomy, change in therapy indicative of more advance disease or death (any cause), whichever occurs first. |
| Secondary | Cohort B: Disease Free Survival | 13 Years and 3 Months | DFS was assessed in the following groups: 1\) All recurrent bladder cancer, including low grade Ta disease the time from randomization until recurrence of any grade Ta (including low grade Ta) or any grade T1, CIS, disease progression, cystectomy, change in therapy indicative of more advanced disease, or death (any cause), whichever occurs first 2) Patients who have high-grade Ta, low-grade T1, or CIS at 3-months and received re-induction, and have no evidence of \> low-grade Ta disease at 6-months will be considered disease-free from randomization until a second recurrence \> low-grade Ta 3) Patients who have high-grade Ta, low-grade T1, or CIS at 3-months and received re-induction, and have no evidence of any disease (including low grade Ta) at 6-months will be considered disease-free from randomization until a second recurrence ≥ low grade Ta. |
| Secondary | Vital signs and clinical laboratory assessment | 36 Months | Vital signs include heart rate, systolic and diastolic blood pressures, respiration rate, and body temperature. Labs include the following: complete blood count with differential, complete metabolic panel, and urinalysis. |
| Secondary | Long Term Follow Up(LTFU) data from subjects who were treated | 10 Years after treatment period visits | Yearly collection of LTFU data, which includes the following: survival status, bladder cancer status (high 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. |
| Other | Exploratory Endpoints- Immunogenicity: Serum level of anti-N-803 in patient samples | 36 Months | For phase Ib and IIb Measures the serum level of anti-N-803 in patient samples. |
| Other | Quality of Life Endpoint | 39 Months | Quality of Life (QoL) as assessed by the European Organization for Research and Treatment of Cancer (EORTC) questionnaires for patients with cancer (QLQ-C30) and for patients with NMIBC (QLQ-NMIBC24). |
| Other | Exploratory Endpoints- Whole Slide Images (Baseline and any on-study biopsy) | 39 Months | For Phase IIb |
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/NCT02138734/registered