Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Indoximod · 2 trials · 5 indications
For patients with relapsed glioblastoma, medulloblastoma, or ependymoma.
For patients with newly diagnosed DIPG (diffuse intrinsic pontine glioma).
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 |
|---|---|---|
| Core Regimen, sub-cohort A | EXPERIMENTAL | For patients not eligible for re-irradiation; Start with Core Regimen chemo-immunotherapy (indoximod with oral temozolomide). |
| Core Regimen, sub-cohort B | EXPERIMENTAL | For patients who are eligible for partial re-irradiation; Start with indoximod plus up-front re-irradiation, using a palliative low-dose or partial-field radiation plan (low-dose radiation or not all disease sites included); Followed by Core Regimen chemo-immunotherapy (indoximod with oral temozolomide). |
| Core Regimen, sub-cohort C | EXPERIMENTAL | For patients who are eligible for full-dose radiation; (All newly diagnosed DIPG patients and some relapsed ependymoma patients); Start with indoximod plus up-front radiation, using a palliative full-dose radiation plan to all known sites of disease (\>50 Gy to brain, \>45 Gy to spine); Followed by Core Regimen chemo-immunotherapy (indoximod with oral temozolomide). |
| Salvage Regimen 1 | EXPERIMENTAL | For patients who wish to continue access to indoximod after progression on the Core Regimen; Cross-over to indoximod with oral metronomic cyclophosphamide and etoposide). |
| Salvage Regimen 2 | EXPERIMENTAL | For patients who wish to continue access to indoximod after progression on the Core Regimen; Cross-over to indoximod with oral lomustine and temozolomide). |
| 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 during radiation and throughout each chemo-immunotherapy treatment cycle. |
| Partial Radiation | RADIATION | Palliative low-dose or partial-field radiation plan (low-dose radiation or not all disease sites included). |
| Full-dose Radiation | RADIATION | Palliative full-dose radiation plan to all known sites of disease (\>50 Gy to brain, \>45 Gy to spine). |
| Temozolomide | DRUG | Temozolomide will be taken by mouth once daily, on days 1-5 of each chemo-immunotherapy treatment cycle. |
| Cyclophosphamide | DRUG | Cyclophosphamide will be taken by mouth once daily, on days 1-21 of each chemo-immunotherapy treatment cycle. |
| Etoposide | DRUG | Etoposide will be taken by mouth once daily, on days 1-21 of each chemo-immunotherapy treatment cycle. |
| Lomustine | DRUG | Lomustine will be taken by mouth once daily, on day 1 of each chemo-immunotherapy treatment cycle. |
| Ibrutinib | DRUG | For Regimen A, Ibrutinib will be taken by mouth once daily, on days 1-21 of each treatment cycle. |
Inclusion Criteria: Diagnosis: * Progressive disease with histologically proven initial diagnosis of glioblastoma, medulloblastoma, or ependymoma; With confirmation of progression by either MRI or CSF analysis; Measureable disease is not required for study entry; Patients with progressive disease ...
Indoximod is an investigational small molecule being studied for the treatment of pediatric brain tumors, including ependymoma and glioblastoma. It is also being evaluated in medulloblastoma and diffuse intrinsic pontine glioma. The drug is in clinical development and has not been approved by the FDA.
Indoximod is an investigational small molecule that targets the IDO pathway, which is involved in immune suppression in the tumor microenvironment. By modulating this pathway, Indoximod is being studied to enhance the immune system's ability to fight cancer cells in pediatric brain tumors.
Indoximod is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical trials to evaluate the drug's safety and efficacy in pediatric patients with brain tumors.
Indoximod is in Phase 1 clinical development. It is being studied in combination with ibrutinib for pediatric brain cancer. The drug is investigational and has not received FDA approval.
Indoximod is being studied in two clinical trials. NCT04049669 is a Phase 2 trial of Indoximod with chemotherapy and radiation for relapsed brain tumors or newly diagnosed DIPG. NCT05106296 is a Phase 1 trial of chemo-immunotherapy using ibrutinib plus Indoximod for pediatric brain cancer.
Indoximod is a distinct investigational drug and is not known to be the same as any other approved medication. It is being studied under its own name in clinical trials for pediatric brain tumors.