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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05106296 | Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer | PHASE1 | RECRUITING | 37 | — | — | Feb 8, 2022 | Sep 30, 2028 | Jan 9, 2026 | 1 | United States |
To determine the pediatric recommended phase 2 dose (RP2D) of ibrutinib, when combined with indoximod-based chemo-immunotherapy (Regimen A)
Defined as the proportion of patients with a best objective response of either complete response (CR) or partial response (PR), using "immunotherapy Response Assessment for Neuro-Oncology" (iRANO) criteria
To determine the pediatric recommended phase 2 dose (RP2D) of ibrutinib, when combined with indoximod-based chemo-immunotherapy (Regimen B)
Defined as the proportion of patients with a best objective response of either complete response (CR) or partial response (PR), using "immunotherapy Response Assessment for Neuro-Oncology" (iRANO) criteria
| Arm | Type | Description |
|---|---|---|
| Regimen A | EXPERIMENTAL | Patients will be treated with ibrutinib plus indoximod, cyclophosphamide, and etoposide. Cycles are a minimum of 28 days. |
| Regimen B | EXPERIMENTAL | Patients will be treated with ibrutinib plus indoximod and temozolomide. Cycles are a minimum of 28 days. |
| Name | Type | Description |
|---|---|---|
| Indoximod | DRUG | Indoximod will be taken by mouth twice daily, throughout each treatment cycle. |
| Ibrutinib | DRUG | For Regimen A, Ibrutinib will be taken by mouth once daily, on days 1-21 of each treatment cycle. |
| Cyclophosphamide | DRUG | Cyclophosphamide will be taken by mouth once daily, on days 1-21 of each treatment cycle. |
| Etoposide | DRUG | Etoposide will be taken by mouth once daily, on days 1-21 of each treatment cycle. |
| Temozolomide | DRUG | Temozolomide will be taken by mouth once daily, on days 1-5 of each treatment cycle. |
Inclusion Criteria: Diagnosis: * Patients must have prior documented progressive or refractory disease with histologically proven initial diagnosis of ependymoma, medulloblastoma, glioblastoma, or another type of primary cancer of the central nervous system with no curative conventional therapy op...