Clinical Trials for Brain Tumor

Phase I Study of Cellular Immunotherapy Using Memory Enriched T Cells Lentivirally Transduced to Express an IL13Rα2-Targeting, Hinge-Optimized, 41BB-Costimulatory Chimeric Receptor and a Truncated CD19 for Children With Recurrent/Refractory Malignant Brain Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Pediatric patients with recurrent or refractory IL13Rα2-positive malignant brain tumors receive lymphodepleting cyclophosphamide/fludarabine followed by repeated intraventricular infusions of autologous IL13Rα2-targeted CAR T cells (IL-13 mutein binder, 4-1BB/CD3ζ; includes truncated CD19). Locoregional delivery aims to enhance CNS exposure while monitoring safety, CAR T persistence, and preliminary antitumor activity.

ClinicalTrials.gov ID: NCT04510051

Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with melanoma and at least one measurable, untreated brain metastasis (0.5–3 cm), ECOG 0–1, and no steroid-requiring neurologic symptoms receive fixed-dose nivolumab (PD-1 inhibitor) plus relatlimab (LAG-3 inhibitor) IV every 28 days. Prior limited SRT/excision allowed if non-irradiated measurable disease remains; excludes leptomeningeal disease, lesions >3 cm, prior metastatic PD-1 therapy, and significant autoimmune/infectious comorbidities.

ClinicalTrials.gov ID: NCT05704647

Phase 1 Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma/Diffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Enrolls children and young adults (1–26 years) with DIPG/DMG after standard therapy or with recurrent/refractory primary CNS tumors lacking options, requiring an indwelling CNS catheter. Investigational treatment is autologous B7-H3 (CD276)–targeted CAR T cells (SCRI-CARB7H3/BCB-276) delivered locoregionally via tumor cavity or intraventricular catheter without lymphodepletion, with dosing over two courses and safety/feasibility as primary endpoints.

ClinicalTrials.gov ID: NCT04185038

A Phase 0, Single-center, Open-label, Dose-escalating Trial Using Super-selective Intra-arterial Infusion of a Single Dose of Temsirolimus for the Treatment of Recurrent High-grade Glioma

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with recurrent, resectable WHO grade 3–4 frontal lobe glioma that is mTOR‑pathway positive (e.g., PTEN loss or PI3K/AKT/mTOR alterations) after prior Stupp regimen receive a single pre-resection dose of temsirolimus given via super-selective intra-arterial infusion or standard IV. Temsirolimus is an mTORC1 inhibitor; the study compares intratumoral drug exposure and target inhibition (pS6) between delivery routes.

ClinicalTrials.gov ID: NCT05773326

Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with advanced cancers and actively progressing, measurable, untreated asymptomatic brain metastases (including BRCA1/2-mutated, other HRR-aberrant tumors, SCLC, NSCLC, and TNBC) receive niraparib (PARP inhibitor exploiting HRD/synthetic lethality) plus dostarlimab (PD‑1 inhibitor) to assess intracranial response and durability; prior PD‑1/L1 allowed, prior full‑dose PARP monotherapy excluded. Requires ECOG 0–2, adequate organ function, no leptomeningeal disease, and no need for immediate local therapy or steroids.

ClinicalTrials.gov ID: NCT05700721

Phase 1 Trial of Engineered HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Children and young adults (3 to <22 years) with recurrent or progressive malignant cerebellar brain tumors (e.g., medulloblastoma, high‑grade glioma/GBM, ependymoma, ATRT, PNET, germ cell tumor) with surgically accessible lesions ≤3 cm receive intratumoral G207, an engineered, tumor‑selective oncolytic HSV‑1 (γ34.5 deletions, UL39 inactivation; TK‑retained), with later cohorts also receiving a single 5‑Gy focal radiation dose within 24 hours. Key exclusions include diffuse multifocal disease (≥3 lobes), need for ventricular/brainstem inoculation or access, active infection/immunosuppression, and concurrent anticancer therapy.

ClinicalTrials.gov ID: NCT03911388

DURABLE: Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and rEarrangements

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with treatment-naïve, stage IV ALK-rearranged NSCLC and asymptomatic or minimally symptomatic brain metastases are randomized to alectinib (ALK TKI with strong CNS activity) alone with delayed brain RT versus upfront stereotactic radiosurgery followed by alectinib. Designed to assess neurologic outcomes and CNS control, with a Phase 1b run-in for safety/feasibility of alectinib.

ClinicalTrials.gov ID: NCT05987644

A Phase 2 Study of Erdafitinib in Patients With Recurrent or Progressive IDH-Wild Type Glioma With an FGFR-TACC Gene Fusion

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with recurrent/progressive IDH–wild type glioma (WHO grade 2–4) harboring a CLIA-confirmed FGFR–TACC fusion receive oral erdafitinib monotherapy (continuous 28-day cycles) until progression/toxicity. Erdafitinib is a pan-FGFR1–4 tyrosine kinase inhibitor targeting the oncogenic FGFR–TACC fusion; prior FGFR inhibitor exposure is excluded.

ClinicalTrials.gov ID: NCT05859334

An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients with Select Solid Tumors.

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

TrialFetch AI summary: This clinical trial evaluates the safety and efficacy of the investigational drug NEO212, a novel conjugate of temozolomide and perillyl alcohol with enhanced brain penetration, in adults with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype, or uncontrolled brain metastases from select solid tumors, including combinations with standard treatments like pembrolizumab or ipilimumab.

ClinicalTrials.gov ID: NCT06047379

A Randomized Pivotal Study Assessing the Safety and Efficacy of Targeted Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound During the Standard of Care Treatment of Brain Metastases of Non-small Cell Lung Cancer (NSCLC) Origin

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adult patients with NSCLC and measurable brain metastases eligible for immune checkpoint inhibitor therapy are randomized to receive standard ICI treatment alone or in combination with targeted blood-brain barrier opening using Exablate focused ultrasound, a device-based method to enhance drug delivery to brain lesions.

ClinicalTrials.gov ID: NCT05317858