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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05843448 | IDO and PD-L1 Peptide Based Immune-Modulatory Therapeutic (IO102-IO103) in Combination With Pembrolizumab for BCG-Unresponsive or Intolerant, Non-Muscle Invasive Bladder Cancer | PHASE1 | RECRUITING | 30 | — | — | Apr 19, 2023 | Dec 1, 2026 | Mar 13, 2026 | 1 | United States |
Safety and toxicity will be evaluated according to Common Terminology Criteria for Adverse Events version 5.0 and pre-defined treatment-limiting toxicities.
| Arm | Type | Description |
|---|---|---|
| Treatment (IO102-IO103, pembrolizumab) | EXPERIMENTAL | Patients receive PD-L1/IDO peptide vaccine SC and pembrolizumab IV on study. Patients also undergo CT and/or CT/PET and collection of blood samples throughout the trial. |
| Name | Type | Description |
|---|---|---|
| PD-L1/IDO Peptide Vaccine | BIOLOGICAL | Given SC |
| Pembrolizumab | BIOLOGICAL | Given IV |
Inclusion Criteria: * Adults \>= 18 years of age * Histologically confirmed high-risk NMIBC (T1, high-grade Ta, or carcinoma in situ \[CIS\]/Tis). Mixed histologies are allowed if predominantly transitional cell histology. Archival tissue or planned cystoscopy within 28 day of planned initiation of...