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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04165317 | A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 1,068 | — | — | Dec 30, 2019 | Dec 2, 2026 | Jan 22, 2026 | 194 | United States, Australia +12 |
EFS: time from randomization till recurrence of high-grade disease, progression of disease, persistence of carcinoma in situ (CIS), death due to any cause, whichever occurred first. Recurrence of high-grade disease: re-appearance of high-grade disease after randomization/study intervention initiation, re-appearance of high-grade disease after complete response (CR) for CIS participants or re-appearance of high-grade disease before CR for CIS participants and concurrent papillary disease at baseline. Progression of disease defined as any of following: Lamina propria invasion, muscle invasive disease, lymph node positive disease, metastatic disease, high-grade stage of bladder cancer (non-invasive papillary carcinoma \[Ta\] or invasion into the lamina propria without invasion into the muscularis propria \[T1\]) in participants with CIS only at baseline before achieving CR. Persistence of CIS: persistent CIS after induction, re-induction. EFS estimated using Kaplan-Meier analysis.
| Arm | Type | Description |
|---|---|---|
| PF-06801591 + BCG induction and maintenance | EXPERIMENTAL | PF-06801591 in combination with Bacillus Calmette Guerin(induction+maintenance). |
| PF-06801591 + BCG induction only | EXPERIMENTAL | PF-06801591 in combination with Bacillus Calmette Guerin (induction only). |
| BCG induction and maintenance | ACTIVE_COMPARATOR | Bacillus Calmette Guerin (induction and maintenance). |
| BCG Unresponsive CIS | EXPERIMENTAL | PF-06801591 |
| BCG Unresponsive NMIBC | EXPERIMENTAL | PF-06801591 |
| Name | Type | Description |
|---|---|---|
| PF-06801591 | DRUG | A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2. |
| Bacillus Calmette-Guerin | DRUG | Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer |
Inclusion Criteria: * Histological confirmed diagnosis of high risk non-muscle invasive transitional cell carcinoma (TCC) of the urothelium of the urinary bladder (tumors of mixed transitional/non-transitional cell histology are allowed, but TCC must be the predominant histology) * Complete resecti...