Clinical Trials for Brain Tumor

A Phase I/II Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon Combined With Stereotactic Radiation Therapy in Patients With 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.

No known activity

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

TrialFetch AI summary: Adults with solid-tumor brain metastases (largest lesion ≤2 cm), off steroids before SRS and ≥2 months from prior cranial RT, receive stereotactic radiosurgery plus azeliragon, an oral RAGE inhibitor aimed at reducing inflammation/vascular dysfunction and potentially overcoming radioresistance. Single-arm dose-finding then expansion assesses safety and early intracranial response versus historical SRS outcomes; excludes leptomeningeal disease and strong CYP2C8 inhibitor use.

ClinicalTrials.gov ID: NCT05789589

Pre-Operative vs. Post-Operative Stereotactic Radiosurgery for Operative Metastatic Brain 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.

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: Adults with a single resectable intraparenchymal brain metastasis (solid tumors; ECOG 0–2; ≤10 total brain lesions) are randomized to stereotactic radiosurgery given either before or after surgical resection, excluding prior WBRT, leptomeningeal disease, lesions near the optic chiasm, very large lesions (>5 cm), or certain histologies. The trial compares pre-op versus post-op SRS using standard-of-care techniques to determine impact on CNS control (local recurrence, LMD, symptomatic radiation necrosis) and survival/quality-of-life outcomes.

ClinicalTrials.gov ID: NCT03750227

A Randomized Phase 2 Trial of Encorafenib + Binimetinib + Nivolumab vs Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With 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.

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: Adults with BRAF V600–mutant melanoma and active, measurable brain metastases (including leptomeningeal disease), no prior systemic therapy for metastatic disease, are randomized to encorafenib (BRAF inhibitor) + binimetinib (MEK1/2 inhibitor) plus nivolumab (PD-1 antibody) versus standard ipilimumab (CTLA-4 antibody) + nivolumab. Allows limited steroids, extracranial disease, and prior adjuvant/neoadjuvant therapy; excludes uveal melanoma and significant autoimmune or recent radiation contraindications.

ClinicalTrials.gov ID: NCT04511013

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.

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: 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

A Phase III Trial of Pre-Operative Stereotactic Radiosurgery (SRS) Versus Post-Operative SRS for 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.

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: Adults with 1+ surgically resectable brain metastases (≤4 cm single-fraction or ≤7 cm multifraction; KPS ≥70/ECOG ≤2; no prior brain RT or LMD; excluding SCLC, lymphoma, leukemia, myeloma) are randomized to pre-operative SRS followed by craniotomy versus surgery followed by adjuvant SRS. The trial compares these standard-of-care strategies for 1-year leptomeningeal disease, with secondary endpoints including local/distant brain control, survival, neurocognition, and quality of life.

ClinicalTrials.gov ID: NCT03741673

A Phase I Study of Intra-Tumoral Injections of Ex Vivo Expanded Natural Killer Cells in Children and Young Adults With Recurrent or Progressive Malignant Brain Tumors

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 (1–39 years) with recurrent or progressive malignant supratentorial brain tumors undergoing resection and Ommaya placement receive weekly intratumoral infusions of universal donor, ex vivo–expanded, TGFβ-imprinted natural killer cells for up to three 28‑day cycles. The NK cells are engineered ex vivo to resist TGFβ-mediated immunosuppression and enhance antitumor cytotoxicity; key exclusions include need for ventricular/brainstem access, uncontrolled infection, significant comorbidities, and immunosuppression.

ClinicalTrials.gov ID: NCT05887882

A Combination Therapy Trial Using an Adaptive Platform Design for Children and Young Adults With Diffuse Midline Gliomas (DMGs) Including Diffuse Intrinsic Pontine Gliomas (DIPGs) at Initial Diagnosis, Post-Radiation Therapy and at Time of Progression

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

No known activity

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

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.

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: Children, adolescents, and young adults (2–39 years) with diffuse midline glioma/DIPG at diagnosis, post-radiation, or first progression receive ONC201 (dordaviprone; DRD2/3 antagonist and ClpP activator activating the integrated stress response) as backbone therapy, with cohorts optimizing ONC201 dosing (including with radiation/ re-irradiation) or combining ONC201 with targeted agents (e.g., paxalisib [PI3K/mTOR inhibitor] or alteration-guided therapies for BRAFV600E, PDGFRA, FGFR1, NF1). Allocation is nonrandomized and molecularly guided in active cohorts.

ClinicalTrials.gov ID: NCT05009992

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.

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: 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 Study of Locoregional Injections of Ex Vivo Expanded Natural Killer Cells in Children and Young Adults With Recurrent, Progressive, or Refractory Brain Tumors

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 with recurrent, progressive, or refractory primary CNS tumors (excluding DMG/DIPG) receive repeated locoregional infusions of universal-donor, TGFβ-imprinted natural killer cells via Ommaya reservoir or programmable VP shunt. The NK product is engineered ex vivo to resist TGFβ-mediated suppression and maintain cytotoxicity in TGFβ-rich brain tumor microenvironments; measurable disease is not required but patients must be eligible for intratumoral or intraventricular access.

ClinicalTrials.gov ID: NCT04254419

ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas

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: Adults with first recurrence of WHO grade 2–3 IDH1 R132H–mutant, predominantly nonenhancing glioma (KPS ≥70) receive oral vorasidenib (brain‑penetrant mutant IDH1/2 inhibitor) plus PEPIDH1M, an intradermal peptide vaccine targeting the IDH1 R132H neoepitope with GM‑CSF/Montanide and Td priming. Excludes prior mutant IDH therapy and measurable enhancing disease >1×1 cm; primary endpoints focus on safety and PFS.

ClinicalTrials.gov ID: NCT05609994