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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03978624 | Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 20 | — | — | Sep 23, 2020 | Nov 22, 2026 | Oct 15, 2025 | 2 | United States |
Gene expression levels with the CD8 T cell gene signature were measured using RNA sequencing. The expression level of each gene in the signature were log2 transformed and the mean of the signature genes was calculated in each sample. Then the mean expression of signature in each sample was compared to the average expression and variability across other sample to center the expression values (mean = 0) and scale them by standard deviation and generate a Z-score. Change in z-score was then calculated between pre- and post-treatments for each individual patient and then changes in z-score were compared between treatment arms. An increase in Z-score with treatment denotes an increase in expression of the immune gene signature (IGS).
| Arm | Type | Description |
|---|---|---|
| A: Pembrolizumab alone | EXPERIMENTAL | Subjects will be administered pembrolizumab alone 200 mg IV on day 1 and day 22 |
| B: Pembrolizumab plus Entinostat | EXPERIMENTAL | Subjects will be administered pembrolizumab on day 1 and day 22 and entinostat 5 mg given orally on day 1, day 8 and day 15 |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | DRUG | 200 mg IV on day 1 and day 22 |
| Entinostat | DRUG | 5 mg given orally on day 1, day 8 and day 15 |
| Procedure/Surgery | PROCEDURE | A radical cystectomy is a surgical procedure to remove the entire urinary bladder and maximal transurethral resection of bladder tumor (TURBT) is a surgical procedure used to remove as much of the bladder tumor as possible. |
Inclusion Criteria: * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. * Subjects must agree to donate tumor tissue from their transurethral resection of the bladder tumor (TURBT) and from their cystectomy, as well as ...