The Stanford Neuro-Oncology Program Adult Clinical Trials

Newly Diagnosed Glioma

A Phase I Study of Tumor Treating Fields with 5-Day Hypofractionated Stereotactic Radiosurgery and Concurrent and Maintenance Temozolomide in Newly Diagnosed Glioblastoma
PI: Scott Soltys, MD
ClinicalTrials.gov#: NCT04474353
ClinicalTrials.gov#: NCT03746080

A Phase II Study of BPM31510 with Vitamin K1 in Subjects with Newly Diagnosed Glioblastoma (GB)
PI: Seema Nagpal, MD
ClinicalTrials.gov#: NCT04752813

Pivotal, Randomized, Open-label Study of Optune (Tumor Treating Fields) Concomitant with RT & TMZ for the Treatment of Newly Diagnosed GBM (EF-32)
PI: Seema Nagpal, MD
ClinicalTrials.gov#: NCT04471844

ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
PI: Kate Therkelsen, MD
ClinicalTrials.gov#: NCT05580562

Recurrent High Grade Glioma

Phase I Clinical Trial of Locoregionally (LR) Delivered Autologous B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Adults with Recurrent Glioblastoma Multiforme (GBM)
PI: Reena Thomas, MD PhD
ClinicalTrials.gov#: NCT05474378

Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects
PI: Seema Nagpal, MD
ClinicalTrials.gov#: NCT03382977

A Phase Ib Clinical Trial to Evaluate Early Immunologic Pharmacodynamic Parameters Following Neoadjuvant Anti-PD-1 (Nivolumab), or the Combination of Anti-PD-1 Plus Anti-CTLA-4 (Nivolumab Plus Ipilimumab) in Patients With Surgically Accessible Glioblastoma
PI: Michael Lim, MD
ClinicalTrials.gov#: NCT04606316

Brain Metastases

A Phase IIa Study Assessing QBS72S For Treating Brain Metastases of Breast Cancer
PI: Melanie Hayden Gephart, MD
ClinicalTrials.gov#: NCT05305365

Leptomeningeal Metastases

A Longitudinal Therapy Response Monitoring Study in Subjects with Leptomeningeal Metastases using CNSide (CSF Tumor Cells) Compared to Standard of Care (CSF Cytology, Clinical Evaluation, and Imaging)
PI: Seema Nagpal, MD
ClinicalTrials.gov#: NCT05414123

BRAF V600 Mutations

A Phase I, First-In-Human, Multicenter, Open-Label Study of ABM-1310, Administered Orally in Adult Patients with Advanced Solid Tumors
PI: Seema Nagpal, MD
ClinicalTrials.gov#: NCT04190628

FGFR1-3 Alterations

A Phase II, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations (FIGHT-209)
PI: Michael Lim, MD
ClinicalTrials.gov#: NCT05267106

Primary CNS Lymphoma

An Open-Label Phase II Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Tirabrutinib in Patients with Primary Central Nervous System Lymphoma (PCNSL)
PI: Neel Gupta, MD
ClinicalTrials.gov#: NCT04947319