Trial · NCT05106296
Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer
NCT05106296, Phase 1, Recruiting, Theodore S. Johnson
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer. Trials, record NCT05106296. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05106296
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer
- NCT number
- NCT05106296
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 37 participants, estimated
- Lead sponsor
- Theodore S. Johnson
- Conditions
- Ependymoma, Medulloblastoma, Glioblastoma, Primary Brain Tumor
- Interventions
- Indoximod, Ibrutinib, Cyclophosphamide, Etoposide, Ibrutinib, Temozolomide
- First posted
- 2021-11-03
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of regimen-limiting toxicity (RLT) for Regimen A | First 90 days of treatment | To determine the pediatric recommended phase 2 dose (RP2D) of ibrutinib, when combined with indoximod-based chemo-immunotherapy (Regimen A) |
| Primary | Objective Response Rate (ORR) for Regimen A | Up to 5 years | 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 |
| Primary | Incidence of regimen-limiting toxicity (RLT) for Regimen B | First 90 days of treatment | To determine the pediatric recommended phase 2 dose (RP2D) of ibrutinib, when combined with indoximod-based chemo-immunotherapy (Regimen B) |
| Primary | Objective Response Rate (ORR) for Regimen B | Up to 5 years | 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 |
| Secondary | Adverse events (AEs) | Up to 19 months | To assess frequency, severity, and recoverability of AEs for the treatment regimen |
| Secondary | Frequency of cycle delays for toxicity | Up to 18 months | To assess whether the immunotherapy contributes to delays in starting subsequent cycles of the chemotherapy drugs |
| Secondary | Frequency of dose-reductions of the chemotherapy regimen | Up to 18 months | To assess whether the immunotherapy contributes to reductions in the doses of the chemotherapy drugs |
| Secondary | Complete Response Rate (CRR) | Up to 5 years | Defined as the proportion of patients with a best objective response of CR using iRANO criteria |
| Secondary | Partial Response Rate (PRR) | Up to 5 years | Defined as the proportion of patients with a best objective response of PR using iRANO criteria |
| Secondary | Modified Objective Response Rate (mORR) | Up to 5 years | Defined as the proportion of patients with best objective response of complete response (CR), partial response (PR), or stable disease (SD, on at least 2 sequential study-timed MRIs) using iRANO criteria |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05106296
GET https://conductscience.org/api/trials/v1/NCT05106296/registered