Trial · NCT04640623
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohorts 1, 2, and 3: Overall Complete Response (CR) Rate | From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months) | Overall CR rate was defined as the percentage of participants who met at least one of the following: negative cystoscopy and negative (including atypical) centrally read urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade non-muscle invasive bladder cancer (NMIBC) and negative (including atypical) centrally read cytology at any time point. |
| Primary | Cohort 4: Disease-free Survival (DFS) | From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months) | DFS was defined as the time from the date of first dose of study treatment to the time of one of the following events, whichever occurred first: (1) The first recurrence of high-risk disease (high-grade Ta, any T1 or CIS), (2) progression to muscle invasive bladder cancer (MIBC) (T greater than or equal to \[\>=\] 2) or to lymph node (N+) or to distant disease (M+), whichever occurred first, (3) Death due to any cause. |
| Secondary | Cohorts 1, 2, and 3: Number of Participants With at Least 12 Months Duration of Response | From onset of first CR up to clinical cut-off date 3rd July 2025 (up to 47.3 months) | DOR was defined as the date of first complete response (CR) achieved to the date of first evidence of recurrence or progression or death, using cystoscopy, centrally read bladder biopsy and urine cytology, and imaging, if available. Complete response was defined as having a negative cystoscopy and negative (including atypical) centrally assessed urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative (including atypical) centrally assessed cytology at any time point. Number of participants with at least 12 months duration of response were reported. |
| Secondary | Overall Survival (OS) | From Week 0 up to 6 years 7 months | |
| Secondary | Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite) | Predose at Week 0 and at any time between Days 2-7 during Weeks 3, 6, 9, 15, 18, and 21 postdose | Plasma concentrations of gemcitabine and dFdU were reported. |
| Secondary | Cohorts 1 and 2: Maximum Observed Urine Concentration (Cmax) of Gemcitabine and dFdU (Metabolite) | At Week 0 | Cmax was defined as maximum observed urine concentration. |
| Secondary | Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite) | At Weeks 3, 6, 9, 15, 18, and 21 | Urine concentrations of gemcitabine and dFdU were reported. |
| Secondary | Cohort 1and 3: Serum Concentration of Cetrelimab | At Weeks 0, 3, 12, 24, 48, 60, 84 (end of infusion) [EOI] | Serum concentration of cetrelimab were reported. |
| Secondary | Cohort 3: Serum Concentration of Cetrelimab | At Weeks 60 (EOI) | Serum concentration of cetrelimab were reported. |
| Secondary | Cohorts 1 and 3: Number of Participants With Anti-cetrelimab Antibodies | From date of first dose up to clinical cut-off date 3rd July 2025 (54 months) | Number of participants positive to anti-cetrelimab antibodies was reported using validated immunoassay for anti-drug antibody (ADA) analysis. |
| Secondary | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30 Scores | From Week 0 up to 6 years 7 months | |
| Secondary | Change From Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores | From Week 0 up to 6 years 7 months | |
| Secondary | Time to Symptom Deterioration as Assessed by European Organisation for Research and Treatment of Cancer Qualityof-life Questionnaire (EORTC QLQ) -C30 Scores | From Week 0 up to 6 years 7 months | |
| Secondary | Time to Symptom Deterioration as Assessed by EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores | From Week 0 up to 6 years 7 months | |
| Secondary | Number of Participants With Adverse Events (AEs) by Severity Grades | From Week 0 up to 6 years 7 months | |
| Secondary | Number of Participants With Clinical Laboratory Abnormalities by Severity Grades | From Week 0 up to 6 years 7 months |
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.
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