Clinical Trials for Brain Tumor

Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

TrialFetch AI summary: Adults with 1-8 intact (unresected), non-brainstem brain metastases from solid tumors (such as NSCLC, melanoma, breast, renal, or GI cancers), good performance status, and no prior brain radiotherapy are randomized to receive either single-session stereotactic radiosurgery (SRS) or fractionated SRS (three sessions). Both approaches are non-invasive, high-precision outpatient radiotherapy options for brain metastases.

ClinicalTrials.gov ID: NCT06500455

A Multi-Center Phase I Dose Escalation Study of Avutometinib, a RAF/MEK Clamp, in Pediatric Patients With Refractory or Recurrent Solid Tumors Harboring Activating MAPK Pathway Alterations

Active drug

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

TrialFetch AI summary: Pediatric and young adult patients (3–30 years) with refractory or recurrent solid tumors, including CNS tumors, harboring activating MAPK pathway alterations (e.g., BRAF/RAF fusions or mutations, RAS, PTPN11, SOS1/2, NF1 loss) receive oral avutometinib. Avutometinib is a first-in-class RAF/MEK “clamp” that allosterically inhibits RAF and MEK to suppress MAPK signaling; prior RAF/MEK monotherapy is allowed, and key exclusions include significant ocular, cardiac, or rhabdomyolysis risk.

ClinicalTrials.gov ID: NCT06104488

A Three-part, Phase I/II Dose-Escalation Study to Define the Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 With Subsequent Extension of Optimal Dose in Recurrent GBM Subjects

Active drug

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

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 first-recurrent, supratentorial, IDH-wildtype GBM (KPS ≥70%) receive the investigational CMV-targeted vaccine VBI-1901—a virus-like particle presenting gB (humoral) and pp65 (T-cell) antigens—given with GM-CSF or AS01B; the randomized extension compares VBI-1901 + GM-CSF versus single-agent nitrosourea (lomustine or carmustine). Key exclusions include high-dose steroids, significant CMV viremia, autoimmune/immunosuppressive conditions, multifocal/leptomeningeal disease, and IDH-mutant tumors.

ClinicalTrials.gov ID: NCT03382977

ICON-RT: Intracranial Consolidation and Deferral of Radiation Therapy in Patients Receiving Approved CNS-Active Systemic Therapeutics

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: This trial enrolls adults with EGFR-mutant NSCLC and at least one measurable brain metastasis (≥1 cm) who are TKI-naïve or recently started osimertinib, randomizing them after 3 months of osimertinib to either continue osimertinib alone or add stereotactic radiosurgery (SRS) to residual brain metastases. It excludes patients with prior brain-directed radiotherapy, leptomeningeal disease, or more than 20 brain metastases after initial TKI therapy.

ClinicalTrials.gov ID: NCT06741085

A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH ADVANCED SOLID 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: This trial enrolls adults with advanced or metastatic solid tumors, including primary brain tumors, who have exhausted standard therapies, with dedicated cohorts for BRAF-mutant melanoma and other BRAF-mutated solid tumors; patients receive PF-07799544, a novel oral brain-penetrant MEK inhibitor, alone or in combination with a pan-mutant BRAF inhibitor (PF-07799933) or encorafenib, depending on tumor type and molecular profile.

ClinicalTrials.gov ID: NCT05538130

Phase II Study of Adagrasib + Stereotactic Radiosurgery (SRS) for Patients With Metastatic KRAS G12C-mutated NSCLC With Untreated 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: This trial enrolls adults with metastatic KRAS G12C-mutated NSCLC and untreated brain metastases (up to 10 lesions, none >3 cm), who are either treatment-naïve or have received up to two prior lines of therapy, to receive combination therapy with the selective KRAS G12C inhibitor adagrasib plus stereotactic radiosurgery. Prior KRAS G12C inhibitor therapy is not allowed.

ClinicalTrials.gov ID: NCT06248606

A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer 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.

TrialFetch AI summary: This trial enrolls adults with HER2-negative metastatic breast cancer and measurable brain metastases (ECOG 0-1, ≤3 prior chemo regimens) to receive utidelone, a microtubule-stabilizing epothilone analog, alone or with capecitabine. Key exclusions include prior capecitabine failure, leptomeningeal disease, or lesions needing urgent intervention.

ClinicalTrials.gov ID: NCT06764940

Safety and Efficacy of Brodalumab in the Treatment of Immune-Related Adverse Events: A Pilot Study

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: This trial enrolls adults with advanced or metastatic solid tumors who developed IL-17–mediated immune-related adverse events after immunotherapy and require systemic steroids, testing brodalumab (an IL-17 receptor A inhibitor) as a potential steroid-sparing treatment for irAEs. Patients receive subcutaneous brodalumab alongside a planned steroid taper.

ClinicalTrials.gov ID: NCT06673329

Brain [18F]-FES PET/CT in the Diagnosis, Treatment Planning and Response Assessment of Brain Metastases in Patients With Estrogen-Receptor Positive Breast Cancer

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: This trial enrolls adults with biopsy-proven estrogen receptor (ER)-positive breast cancer and new or recurrent brain metastases who are candidates for planned radiation therapy, using investigational brain imaging with 18F-FES PET/CT (a radiotracer targeting ER expression) in addition to standard imaging to potentially enhance radiotherapy planning and response assessment.

ClinicalTrials.gov ID: NCT06072807

Repurposing Ibrutinib for Chemo-Immunotherapy in a Phase 1b Study of Ibrutinib With Indoximod Plus Metronomic Cyclophosphamide and Etoposide for Pediatric Patients With Brain Cancer

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: Relapsed/refractory primary CNS tumors in patients aged 6–25 (e.g., ependymoma, medulloblastoma, glioblastoma) with measurable disease and adequate organ function; key exclusions include active autoimmune disease requiring systemic therapy, significant cardiovascular/bleeding risks, warfarin/strong CYP3A inhibitors, and uncontrolled infection. Single-arm regimen of oral ibrutinib (BTK inhibitor) plus indoximod (IDO/TDO pathway modulator restoring T-cell function) with metronomic cyclophosphamide and etoposide in 28+ day cycles.

ClinicalTrials.gov ID: NCT05106296