Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03528694 | Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 1,018 | — | — | May 14, 2018 | Oct 3, 2028 | Apr 14, 2026 | 120 | Australia, Austria +10 |
Disease-free survival using Investigator disease assessments.
| Arm | Type | Description |
|---|---|---|
| Durvalumab plus BCG (induction + maintenance) | EXPERIMENTAL | Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy |
| Durvalumab plus BCG (induction only) | EXPERIMENTAL | Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy |
| BCG treatment (Standard of care therapy) | ACTIVE_COMPARATOR | Bacillus Calmette-Guerrin (BCG) standard of care treatment |
| Name | Type | Description |
|---|---|---|
| Durvalumab (MEDI4736) | BIOLOGICAL | Investigational product |
| Bacillus Calmette-Guerin (BCG) | BIOLOGICAL | Standard of care |
Inclusion Criteria: For inclusion in the study, patients should fulfill the following criteria: * Aged at least 18 years * BCG-naïve (patients who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before study entry are eligible) * Local histologi...