Trial · NCT04960709
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess the safety and tolerability as evaluated by adverse events occurring throughout the study (Safety Run-In part) | At completion of study treatment by the last patient and at 3 months. | Frequency of Adverse Events. |
| Primary | To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by vital signs (blood pressure in mmHg) (Safety Run-In part) | Up to 84 months | |
| Primary | To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by vital signs (pulse rate) in beats per minute (Safety Run-In part) | Up to 84 months | |
| Primary | To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by vital signs (respiration rate) in breaths per minute (Safety Run-In part) | Up to 84 months | |
| Primary | To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by vital signs (temperature) in degrees Celsius (Safety Run-In part) | Up to 84 months | |
| Primary | To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by abnormality in clinical chemistry by liver function (Safety Run-In part) | Up to 84 months | Clinical chemistry will be assessed by liver function assessment (ALT, AST, albumin, total bilirubin measured in units per dL) |
| Primary | Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatin as assessed by abnormality in clinical chemistry by kidney function (Safety Run-In part) | Up to 84 months | Clinical chemistry will be assessed by kidney function assessment in mg/dL |
| Primary | To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by abnormality in clinical chemistry by thyroid function (Safety Run-In part) | Up to 84 months | Clinical chemistry will be assessed by thyroid function assessment in units per mL. |
| Primary | To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by abnormality in haematology (Safety Run-In part) | Up to 84 months | Hematology will be assessed by white cell count, platelet count, absolute neutrophil count and absolute lymphocyte count. |
| Primary | To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as as assessed by ECG (pulse rate) (Safety Run-In part) | Up to 84 months | |
| Primary | Changes in WHO/ECOG performance status (Safety Run-In part) | Up to 84 months | Eastern Cooperative Oncology Group (ECOG) performance status scale range 0 to 5, where 0 is fully active, able to carry on all pre disease performance without restriction - best outcome and 5 -death - worst outcome. |
| Primary | Compare efficacy of durvalumab + tremelimumab + EV (Arm 1) relative to cystectomy (Arm 3) and durvalumab + EV (Arm 2) relative to cystectomy (Arm 3) on EFS (Main Study) | Up to 3 years | Event-free survival (EFS;) is defined as the time from randomization to the first occurrence of any of the following events: recurrence of disease post-radical cystectomy, the first documented progression in participants who did not receive radical cystectomy, failure to undergo radical cystectomy in participants with residual disease, or death due to any cause, up to 3 years. |
| Secondary | 1. To evaluate the efficacy of durvalumab + tremelimumab + EV on pCR rate (Safety Run-in part) | 3 years | Pathologic complete response (pCR) rate is defined as the number of participants whose pathological staging was T0N0M0 as assessed per local pathology and central independent review using specimens obtained via cystectomy, at 3 years. |
| Secondary | 2. To evaluate the efficacy of durvalumab + tremelimumab + EV on EFS (Safety Run-in part) | 3 years | Event-free survival (EFS;) is defined as the time from randomization to the first occurrence of any of the following events: recurrence of disease post-radical cystectomy, the first documented progression in participants who did not receive radical cystectomy, failure to undergo radical cystectomy in participants with residual disease, or death due to any cause, up to 3 years. |
| Secondary | 3. Pathologic complete response (pCR) rates at time of cystectomy in Arm1 vs Arm3 and Arm 2 vs Arm 3 (Main Study part) | 3 years | Pathologic complete response (pCR) rate is defined as the number of participants whose pathological staging was T0N0M0 as assessed per local pathological review using specimens obtained via cystectomy, at 3 years. |
| Secondary | 4. Overall survival (Safety Run-in and Main Study part) | Up to 5 years | Overall Survival is defined as length of time from randomization until the date of death due to any cause, whichever came first, assessed up to 5 years. |
| Secondary | 5. EFS at 24 months (EFS24) (Safety Run-in and Main Study part) | Up to 24 months | EFS24 is defined as proportion of participants alive and event-free at 24 months |
| Secondary | 6. Overall survival rate at 5 years (Safety Run-in and Main Study part) | At 5 years | The proportion of participants alive at 5 years (OS5) is defined as the Kaplan-Meier estimate of OS at 5 years after randomization |
| Secondary | 7. Disease-free survival (DFS) (Safety Run-in and Main Study part) | Up to first recurrence of disease or death up to 5 years | DFS is defined as time from radical cystectomy to recurrence or death, whichever came first, assessed up to 5 years. |
| Secondary | 8. Pathologic downstaging (pDS) rate-to < pT2 (Safety Run-in and Main Study part) | 3 years | pDS rate is defined as the rate of downstaging to \< pT2, including pT0, pTis, pTa, pT1, and N0 |
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
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