OncoMatch/Clinical Trials/NCT05106296
Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer
Is NCT05106296 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for ependymoma.
Treatment: Indoximod · Ibrutinib · Cyclophosphamide · Etoposide · Ibrutinib · Temozolomide — Recent lab-based discoveries suggest that IDO (indoleamine 2,3-dioxygenase) and BTK (Bruton's tyrosine Kinase) form a closely linked metabolic checkpoint in tumor-associated antigen-presenting cells. The central clinical hypothesis for the GCC2020 study is that combining ibrutinib (BTK-inhibitor) with indoximod (IDO-inhibitor) during chemotherapy will synergistically enhance anti-tumor immune responses, leading to improvement in clinical response with manageable overlapping toxicity. The GCC2020 trial is a prospective open-label phase 1 trial to determine the best safe dose of the BTK-inhibitor ibrutinib to use in combination with previously studied chemo-immunotherapy regimens comprised of the investigational IDO-inhibitor indoximod plus oral palliative chemotherapy for participants, age 6 to 25 years, with relapsed or refractory primary brain cancer. Those previously treated with indoximod-based therapy may be eligible, including prior treatment via the phase 2 indoximod study (GCC1949, NCT04049669), the now closed phase 1 study (NLG2105, NCT02502708), or any expanded access (compassionate use) protocols. Ibrutinib will be combined with either indoximod plus oral cyclophosphamide and etoposide (Regimen A) or indoximod plus oral temozolomide (Regimen B). No cross-over between these two regimens will be allowed. Dose-escalation cohorts will determine the best safe dose of ibrutinib for each of these regimens. This will be followed by expansion cohorts, using ibrutinib at the best safe dose for each regimen, to allow assessment of preliminary evidence of efficacy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Prior therapy
Must have received: chemotherapy
Patients must have prior documented progressive or refractory disease
Lab requirements
Blood counts
ANC ≥ 1000/mm3 (independent of growth factor support); Platelets ≥ 100,000/mm3 (independent of transfusion support); Hemoglobin ≥ 8 g/dL (independent of transfusion support)
Kidney function
Creatinine clearance (CLcr) > 25 mL/min (by calculated methods) AND Creatinine ≤ 1.5-times upper limit of age-adjusted normal for age of patient
Liver function
ALT ≤ 3-times upper limit of normal; AST ≤ 3-times upper limit of normal; Total bilirubin ≤ 1.5-times upper limit of normal unless due to Gilbert's syndrome or of non-hepatic origin
Adequate renal function: Creatinine clearance (CLcr) > 25 mL/min (by calculated methods) AND Creatinine ≤ 1.5-times upper limit of age-adjusted normal for age of patient. Adequate liver function: ALT ≤ 3-times upper limit of normal; AST ≤ 3-times upper limit of normal; Total bilirubin ≤ 1.5-times upper limit of normal unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin. Adequate bone marrow function: ANC ≥ 1000/mm3 (independent of growth factor support); Platelets ≥ 100,000/mm3 (independent of transfusion support); Hemoglobin ≥ 8 g/dL (independent of transfusion support).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Augusta University, Georgia Cancer Center · Augusta, Georgia
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